Inspections Observations FY13 (FINAL)

Number of 483 issued from the System*
Inspections ending between 10/1/2012 12:00:00 AM and 9/30/2013 12:00:00 AM
Center Name 483 issued

Foods 2386
Devices 1099
Drugs 690
Veterinary medicine 328
Bioresearch monitoring 273
Biologics 191
Human tissue for transplantation 121
Parts 1240 and 1250 91
Radiological health 32
Sum Product Area 483s from System* 5211
Actual Total in system 483s** 5050
*This table does not represent the complete set of 483's issued
during the fiscal year as some 483's were manually prepared and not
available in this format. The sum of 483's for all Product Areas will be
greater than the actual Total 483's issued during the fiscal year since
a 483 may include citations related to multiple product areas, and
counted more than once, under each relevant product center.
** This is the Actual Total number of 483's issued from this system,
and that are represented in this spreadsheet.
0 AM
Center Name Cite Id Reference Number
Biologics 76 21 CFR 606.100(b)
Biologics 98 21 CFR 606.100(c)
Biologics 160 21 CFR 606.160(a)(1)
Biologics 154 21 CFR 606.160(a)(1)
Biologics 9225 21 CFR 606.171
Biologics 4425 21 CFR 606.60(a)
Biologics 94 21 CFR 606.100(b)(15)
Biologics 41 21 CFR 606.40(a)(1)
Biologics 67 21 CFR 606.65(e)
Biologics 12202 21 CFR 606.170(a)
Biologics 12203 21 CFR 606.170(a)

Biologics 159 21 CFR 606.160(a)(1)
Biologics 224 21 CFR 640.4(f)
Biologics 9236 21 CFR 630.6(b)(1)
Biologics 88 21 CFR 606.100(b)(9)
Biologics 89 21 CFR 606.100(b)(10)

Biologics 9086 21 CFR 600.14(a)(1)
Biologics 9087 21 CFR 600.14(a)(1)
Biologics 15036 21 CFR 610.47(a)(1)(B)
Biologics 15044 21 CFR 610.47(b)(3)
Biologics 15075 21 CFR 610.46(b)(3)

Biologics 86 21 CFR 606.100(b)(7)
Biologics 87 21 CFR 606.100(b)(8)
Biologics 91 21 CFR 606.100(b)(12)
Biologics 93 21 CFR 606.100(b)(14)
Biologics 110 21 CFR 606.120(b)(2)
Biologics 123 21 CFR 606.121(c)(4)
Biologics 129 21 CFR 606.121(c)(8)
Biologics 132 21 CFR 606.121(c)(11)
Biologics 161 21 CFR 606.160(a)(2)
Biologics 198 21 CFR 640.2(c)(3)
Biologics 218 21 CFR 640.3(c)(2)
Biologics 227 21 CFR 640.4(h)

Biologics 338 21 CFR 640.65(b)(2)(i)
Biologics 371 21 CFR 640.72(a)(3)
Biologics 3455 21 CFR 601.12(f)(1)
Biologics 9095 21 CFR 600.80(c)(1)(i)
Biologics 9096 21 CFR 600.80(c)(1)(ii)
Biologics 9220 21 CFR 606.100(b)(20)
Biologics 9223 21 CFR 606.160(b)(6)
Biologics 9269 21 CFR 610.40(h)


Short Description
Maintained and followed
Thorough investigations
Person performing, test results, interpretation
Concurrent documentation
Required records
Biological product deviation report
Equipment observed, standardized, calibrated
Equipment calibration frequency
Record review prior to release
Schedules and procedures for equipment & calibration
Provide space for examination
Maintain and clean equipment
Following manufacturer's instructions
Donor suitability
Notification
Adverse Reaction - Investigations
Adverse Reaction- Reports of Investigations

Qualifications of responsible personnel
Donor suitability procedures not followed
Clean & orderly
Personnel capabilities
Provide proper equipment to meet requirements
Legibility and indelibility
Arm preparation
Storage temps./agitation
Blood & Blood Components
Deferred or not suitable
Written SOPs available for use by personnel
Written methods for investigating adverse reactions
Controlling storage temperatures
Establishment of spec., standards, and test procedures
Provisions to monitor lab test procedures &

instruments
Adequate identification and handling of test samples
Procedures to maintain records of emergency

transfusions
Unsuitable donors
Adverse reaction - Maintenance of Reports
Adverse reaction - fatality
Donations in less than eight weeks
Donor suitability not performed on day of collection
Closed system
Who must report - manufacturer
Who must report - receiving information
When to report
Review of Adverse Experiences - SOPs
Notification w/in 8 weeks
Documentation
Donor suitability by means of medical history
Notify Consignees [Collecting Establishment]
Notify Transfusion Recipients or MD of Record

[Consignee]
Notify Transfusion Recips or MD of Record [Consignee]

Adequate lighting, ventilation, and screening
Provide space for blood withdrawal
Provide adequate toilet facilities
Safe, sanitary, orderly storage
Methods for performance of all tests
Methods for pre-transfusion testing
Criteria for suitability of reissue of returned blood
QC procedures for supplies and reagents
Destruction of obsolete labels
Expiration date
Caution statement - transfusion
Caution statement - manufacturing use
Determination of lot numbers and supplies
Blood not stored between 1-6 deg / shipped 1-10 deg
History of viral hepatitis - close contact
Storage temperatures after collection
Testing - inspection
General requirements - storage

Criteria for plasmapheresis donor suitability
Fresh Frozen Plasma - storage requirements
Medical supervision
Prevention of contamination
Physician review of four month sample
Donor consent
Explanation of hazards
Labeling changes
Maintenance - concurrence
Reporting Requirements
Reporting Requirements - 15-day alert
Reporting Requirements - 15-day alert follow up
Donor notification
Required records - transfusion reaction and complaints
Test for communicable disease agents
Approved screening tests
Shipment/use of reactive units, units from deferred

donors
Sterile system
Same as for whole blood

Long Description
Written standard operating procedures including all steps to be followed in the [collection] [processing]
[compatibility testing] [storage] [distribution] of blood and blood components for [homologous
transfusion] [autologous transfusion] [further manufacturing purposes] are not always [maintained]
[followed] [maintained on the premises]. Specifically, ***
Failure to [perform a thorough investigation] [make a record of the conclusions and follow-up] of [an
unexplained discrepancy] [a failure of a lot or unit to meet any of its specifications]. Specifically,***
Records fail to [identify the person performing the work] [include dates of the various entries] [show test
results] [include interpretation of the results] [show the expiration date assigned to specific products] [be
as detailed as necessary] so as to provide a complete history of the work performed. Specifically, ***
Records are not concurrently maintained with the performance of each significant step in the [collection]
[processing] [compatibility testing] [storage] [distribution] of each unit of blood and blood components
so that all steps can be clearly traced. Specifically, ***
Failure to maintain [donor] [processing] [storage and distribution] [compatibility testing] [quality control]
[general] records. Specifically, ***
Failure to submit a biological product deviation report [within 45 days from the date you acquired
information suggesting that a reportable event occurred]. Specifically, ***
Equipment used in the [collection] [processing] [compatibility testing] [storage and distribution] of blood
and blood components is not [observed] [standardized] [calibrated] on a regularly scheduled basis as
prescribed in the SOP Manual. Specifically, ***
Equipment used in the [collection][processing][compatibility testing][storage and distribution] of blood

and blood components is not observed, standardized and calibrated with at least the frequency required.
Specifically, ***
All records pertinent to a lot or unit were not reviewed before the release or distribution of a lot or unit
of final product. Specifically, ***
The standard operating procedure fails to include a written description of schedules and procedures for
equipment maintenance and calibration. Specifically, ***
Failure to provide adequate space for [private] [accurate] examinations of individuals to determine their
suitability as blood donors. Specifically, ***
Failure to [maintain] [locate] equipment used in the [collection] [processing] [compatibility testing]
[storage] [distribution] of blood and blood products [in a clean and orderly manner] [so as to facilitate
cleaning and maintenance]. Specifically, ***
Failure to use supplies and reagents in a manner consistent with instructions provided by the
manufacturer. Specifically, ***
Failure to ensure that [whole blood] [plasmapheresis] donors meet suitability criteria. Specifically, ***
Failure to make reasonable attempts to notify a donor who has been [deferred based on the results of
tests for evidence of communicable disease agent(s)] [determined not be to suitable as a donor based on
suitability criteria]. Specifically, ***
A thorough investigation of each reported adverse reaction was not made. Specifically,
Written reports of investigations of adverse reactions, including conclusions and follow up, are not
prepared and maintained. Specifically,
The personnel responsible for the [collection] [processing] [compatibility testing] [storage] [distribution]
of blood or blood components are not adequate in [number] [educational background] [training and
experience, including professional training as necessary] to assure competent performance of their
assigned functions, and to ensure that the final product has the safety, purity, potency, identity and
effectiveness it purports or is represented to possess. Specifically, ***
Failure to [follow] [maintain] [maintain on the premises] standard procedures and methods for
determining the suitability of a donor as a source of blood. Specifically, ***
Failure to maintain facilities in a clean and orderly manner. Specifically, ***
Failure to assure that personnel have [capabilities commensurate with] [the necessary training in]
[necessary experience in] [a thorough understanding of] the operations which they perform. Specifically,
***
Failure of equipment to perform in the manner for which it was designed so as to assure compliance with
the official requirements prescribed in 21 CFR 606. Specifically, ***
Records are [illegible] [not indelible]. Specifically, ***
The phlebotomy site is not prepared by a method that gives maximum assurance of a sterile container of
Whole Blood. Specifically, ***
Failure to store platelets immediately after resuspension [at 20 to 24 degrees Celsius with continuous
gentle agitation] [at 1 to 6 degrees Celsius]. Specifically, ***
Failure to maintain temperatures during shipment of [Fresh Frozen Plasma at -18 C or colder]
[Cryoprecipitated AHF at -18 C or colder] [Liquid Plasma at 1 to 10 C] [Plasma at -18 C or colder]
[Platelets as close as possible to the labeled range] [Platelet Rich Plasma as close as possible to the
labeled range] [Red Blood Cells between 1 and 10 C] [Red Blood Cells, Frozen at -65 C or colder] [Source
Plasma at -5 C or colder] [Source Plasma Liquid at 10 C or colder] [Whole Blood as required].
Specifically, ***
Failure to notify the donor [that the donor is deferred or determined not to be suitable] [of the reason for
deferral]. Specifically, ***
Failure to make available written procedures for use by personnel in the areas where the procedures are
performed. Specifically, ***
The standard operating procedure fails to include a written description of the procedures for investigating
adverse donor and recipient reactions. Specifically, ***
The standard operating procedure fails to include a written description of the storage temperatures and
methods of controlling storage temperatures for all blood products and reagents Specifically, ***
Failure to establish scientifically sound and appropriate specifications, standards and test procedures to
assure that blood and blood components are safe, pure, potent and effective. Specifically, ***
Failure to establish adequate provisions for monitoring the [reliability] [accuracy] [precision]
[performance] of laboratory test procedures and instruments. Specifically, ***
Failure to adequately provide for identification and handling of all test samples so that they are accurately
related [to the specific unit of product being tested] [to its donor] [to the specific recipient]. Specifically,
***
Records [including signature by the physician requesting the procedure] are not maintained of all
emergency transfusions [including complete documentation justifying the emergency action].
Specifically, ***
A record is not available from which unsuitable (deferred) donors may be identified so that products from
such individuals will not be distributed. Specifically, ***
Failure to maintain reports of complaints of adverse reactions regarding each unit of blood or blood
product arising as a result of [blood collection] [transfusion]. Specifically, ***
A confirmed, fatal complication of [blood collection] [transfusion] was not [reported as soon as possible]
[submitted in writing within 7 days after the fatality] to the Director, Office of Compliance, Center for
Biologics Evaluation and Research by the [collecting facility in the event of a donor reaction] [facility that
performed the compatibility tests in the event of a transfusion reaction]. Specifically, ***
A person served as a source of blood more than once in 8 weeks and was not examined at the time of
donation and certified by a physician to be in good health as indicated in part in 21 CFR 640.3(b).
Specifically, ***
Failure to determine the suitability of a donor as a source of blood by a qualified physician or by a trained
person under his supervision on the day of collection. Specifically, ***
The blood is [not collected by aseptic methods in a sterile system] [collected using a vented system which
fails to protect the blood against contamination]. Specifically, ***
Failure to submit [a] biological deviation [report] [reports]. Specifically, ***
Failure to [establish] [maintain] [follow] procedures for obtaining information on all [deviations]
[complaints] [adverse events] for a distributed biological product subject to biological product deviation
reporting. Specifically, ***
Biological product deviations [were] [are] not reported within the 45 calendar day timeframe.
Specifically, ***
There are no written procedures for the [surveillance] [receipt] [evaluation] [reporting] of post-marketing
adverse experiences to FDA. Specifically, ***
Failure to make reasonable attempts to notify the donor within 8 weeks after determining that the donor
is deferred or determined not to be suitable for donation. Specifically, ***
Failure to [document that you have successfully notified a deferred donor] [document that you have
made reasonable attempts to notify a deferred donor]. Specifically, ***
Failure to [always] determine donor suitability on the day of collection by means of [medical history] [test
for hemoglobin level] [physical examination]. Specifically, ***
Failure to notify consignees to quarantine all previously collected in-date blood and blood components
identified under the regulations (blood and blood components collected twelve months and less before
the donor's most recent nonreactive screening tests or twelve months and less before the donor's
reactive direct viral detection test) if intended for use [in another person] [for further manufacture into
injectable products]. Specifically, ***
Failure to notify [transfusion recipients who received previous collections of blood and blood components
at increased risk of transmitting HCV infection] [the physician of record for transfusion recipients who
received previous collections of blood and blood components at increased risk of transmitting HCV
infection] of the need for recipient HCV testing and counseling. Specifically, ***
Failure to notify [transfusion recipients who received previous collections of blood and blood components
at increased risk of transmitting HIV infection] [the physician of record for transfusion recipients who
received previous collections of blood and blood components at increased risk of transmitting HIV
infection] of the need for recipient HIV testing and counseling. Specifically, ***
Failure to provide adequate [lighting] [ventilation] [screening of open windows and doors]. Specifically,
***
Failure to provide adequate space for the withdrawal of blood from donors with minimal [risk of
contamination] [exposure to activities and equipment unrelated to blood collection]. Specifically, ***
Failure to provide [adequate] [clean] [convenient] toilet facilities for donors and personnel. Specifically,
***
Failure to store all supplies and reagents used in the [collection] [processing] [compatibility testing]
[storage] [distribution] of blood and blood components in a safe, sanitary and orderly manner.
Specifically, ***
The standard operating procedure fails to include a written description of all tests and repeat tests
performed on blood and blood components during processing. Specifically, ***
The standard operating procedure fails to include a written description of pretransfusion testing, where
pretransfusion testing is applicable, including precautions to be taken to identify accurately the recipient
blood samples and crossmatched donor units. Specifically, ***
The standard operating procedure fails to include a written description of the criteria for determining
whether returned blood is suitable for reissue. Specifically, ***
The standard operating procedure fails to include a written description of the quality control procedures
for supplies and reagents employed in [blood collection] [processing] [pretransfusion testing].
Specifically, ***
Failure to destroy stocks of obsolete labels. Specifically, ***
The container label fails to include the [expiration date, including the day, month, and year] [hour of
expiration, for product less than 72 hours expiration]. Specifically, ***
The product is intended for transfusion and the container label fails to include the statement(s) [Rx
only] [See circular of information for indications, contraindications cautions, and methods of infusion.]
[Properly identify intended recipient.]. Specifically, ***
For products intended for manufacturing use only, the container label fails to contain the statement:
"Caution: For Manufacturing Use Only". Specifically, ***
Appropriate records are not available to determine the lot numbers of [supplies] [reagents] used for
specific [lots] [units] of the final product. Specifically, ***
Reissued blood has not been [stored continuously at 1 to 6 C] [shipped between 1 and 10 C]. Specifically,
***
An individual was used as a source of Blood who had a history of close contact within twelve months of
donation with an individual having viral hepatitis. Specifically, ***
After collection, blood is not [immediately stored at a temperature between 1 and 6 degrees Celsius]
[transported from the donor clinic to the processing laboratory in temporary storage to cool the blood
continuously toward a range between 1 and 6 degrees Celsius]. Specifically, ***
Failure to [visually inspect blood during storage and immediately prior to issue for] [prevent issuance of
blood found to have] abnormal color, physical appearance, or indication or suspicion of microbial
contamination. Specifically, ***
Failure to [store] [maintain] the Red Blood Cells between 1 and 6 degrees Celsius immediately after
processing. Specifically, ***
Failure of a plasmapheresis donor to [meet the same criteria for donor suitability as specified for Source
Plasma donors (21 CFR 640.63)] [be presented the informed consent]. Specifically, ***
Failure to place plasma, separated from red blood cells and intended to be labeled Fresh Frozen Plasma,
in a freezer within eight hours after phlebotomy at a temperature of -18 degrees Celsius or colder.
Specifically, ***
Failure to have a qualified licensed physician on the premises when [donor suitability is being
determined] [immunizations are being made] [whole blood is being collected] [red blood cells are being
returned to donors]. Specifically, ***
The phlebotomy site is not prepared by a method that gives maximum assurance of a sterile container of
blood. Specifically, ***
Failure of the physician or physician substitute to [review] [sign] the [plasma or serum protein
electrophoresis data] [collection records] within 21 days after the sample was drawn. Specifically, ***
Failure to maintain the original or a clear copy of the donor's written consent for participation in the
plasmapheresis program or for immunization. Specifically, ***
Failure to explain to the prospective Source Plasma donor [by a qualified physician] the [hazards of the
plasmapheresis procedure] [risks of a hemolytic transfusion reaction] [hazards involved if the donor is
hyperimmunized]. Specifically, ***
Failure to [submit a supplement] [receive FDA approval] before distributing the product with labeling
changes. Specifically, ***
Records are not made [concurrently with the performance] of each step in the [manufacture]
[distribution] of products. Specifically, ***
Adverse experience information was not reported to FDA as required. Specifically, ***
All [serious] [unexpected] adverse experiences were not reported within 15 calendar day of initial receipt
of the information. Specifically, ***
Regarding the follow up of [serious] [unexpected] adverse experiences, [investigations were not promptly
performed] [follow-up reports containing new information were not submitted in the appropriate time
frames] [there is no documentation of unsuccessful attempts to seek additional information]. Specifically,
***
The standard operating procedure fails to include a written description of the [donor notification process]
[process for follow-up if the initial attempt at donor notification fails]. Specifically, ***
Failure to maintain records of transfusion reaction reports and complaints, including investigation and
follow up. Specifically, ***
Failure to test each donation of human [blood] [blood components] for evidence of [HIV, type 1] [ HIV,
type 2] [Hepatitis B virus] [Hepatitis C virus] [HTLV, type 1] [HTLV, type 2]. Specifically, ***
Blood or blood components were not tested for evidence of infection due to communicable disease
agents [using screening tests that the FDA has approved for such use][in accordance with the
manufacturer's instructions]. Specifically, ***
Human blood or blood components that were [reactive by a screening test] [collected from a donor with
a previous record of a reactive screening test] for evidence of a communicable disease agent were
[shipped] [used] without meeting the exceptions set forth at 21 CFR 610.40(h)(2). Specifically, ***
Failure to ensure that all surfaces that come into contact with red cells are [sterile] [pyrogen-free].
Specifically, ***
Blood for reagent red blood cells is not collected from peripheral donors as prescribed under applicable
sections of the regulation for the collection of whole blood. Specifically, ***
Frequency
105
44
26
18
18
18
10
5
5
2
2
1
1
1
1
1
1
1
Bioresearch 7560 21 CFR 312.60

monitoring
Bioresearch 7530 21 CFR 312.62(b)
monitoring
Bioresearch 7318 21 CFR 56.115(a)(2)

monitoring
Bioresearch 7526 21 CFR 312.62(a)

monitoring
monitoring

monitoring

monitoring

monitoring

monitoring

monitoring
Bioresearch 7290 21 CFR 56.108(c)

monitoring

monitoring

monitoring
Bioresearch 7293 21 CFR 56.109(f)
monitoring
Bioresearch 7320 21 CFR 56.109(e)

monitoring
monitoring
monitoring
Bioresearch 3926 21 CFR 58.35(b)(1)

monitoring

monitoring
monitoring
monitoring
monitoring
monitoring

monitoring

monitoring

monitoring

monitoring

monitoring

monitoring

monitoring

monitoring
monitoring

monitoring

monitoring
monitoring

monitoring

monitoring

monitoring

monitoring
Bioresearch
7353 21 CFR 50.52
monitoring

monitoring

monitoring

monitoring
monitoring

monitoring

monitoring

monitoring
monitoring

monitoring

monitoring

monitoring

monitoring

monitoring
Bioresearch 7411 21 CFR 312.53(c)(1)

monitoring

monitoring
Bioresearch
monitoring 7459 21 CFR 312.57(a)

monitoring
monitoring

monitoring

monitoring
monitoring

monitoring

monitoring

monitoring
monitoring
Bioresearch 4047 21 CFR 58.195(g)
monitoring
monitoring
monitoring
monitoring
monitoring
Bioresearch 7369 21 CFR 56.109(h)

monitoring

monitoring

monitoring

monitoring
Bioresearch 7456 21 CFR 312.57(d)

monitoring

monitoring
monitoring

monitoring

monitoring

monitoring

monitoring
monitoring

monitoring

monitoring

monitoring

monitoring

monitoring
Bioresearch
monitoring 3943 21 CFR 58.45

monitoring
monitoring
monitoring
monitoring
monitoring
Bioresearch 3978 21 CFR 58.90(g)
monitoring

monitoring

monitoring

monitoring

monitoring

monitoring

monitoring

monitoring

monitoring
monitoring
monitoring
monitoring
monitoring
Bioresearch
monitoring 4040 21 CFR 58.190(d)

monitoring

monitoring
Bioresearch 7322 21 CFR 56.111 (a)(2)

monitoring

monitoring
monitoring

monitoring

monitoring

monitoring
Bioresearch 7373 21 CFR 56.109(c)(1)

monitoring

monitoring

monitoring

monitoring

monitoring

monitoring

monitoring
Bioresearch
monitoring 7483 21 CFR 312.55(b)

monitoring

monitoring
monitoring

monitoring
monitoring

monitoring

monitoring

monitoring

monitoring

monitoring

monitoring

monitoring

monitoring

monitoring
Short Description
FD-1572, protocol compliance
Case history records- inadequate or inadequate
Minutes of IRB meetings
Accountability records
Initial and continuing reviews
List of members
Consent form not approved/signed/dated
Unanticipated problems
General responsibilities of sponsors
Informed consent
Members present for review
Consent not obtained, exceptions do not apply
Written procedures per 56.108(a) and (b)
Continuing review
IRB approvals/disapprovals - general

Safety reports
Reporting findings and actions to

investigator/institution
QAU: maintain a master schedule
Minor changes
Copies of IRB/CI correspondence
Children as subjects
Reasonably foreseeable risks or discomforts
Management: personnel understand their functions
QAU: authorize deviations from protocols or SOPs
At least five members with varying backgrounds
Copies of all research proposals and related documents
Retention of records
Prompt reporting of noncompliance
More frequent reviews, verification of no changes
Transfer of obligations
Initial and continuing review

Research not eligible for expedited review
Personnel: education, training, experience
Study director: follow study protocol
Equipment: calibration
SOPs: required
Conduct: in accordance with protocol
Archives: data, documentation, specimens
Method to keep members advised
Factors required for approval
Ensuring compliance with plan and protocol
Record retention
Understandable language
QAU: monitor facilities, etc.
QAU: review final study report
SOPs: laboratory methods
Conduct: date and sign
Procedures, identification of those which were

experimental
Prompt reporting of unanticipated problems
Reporting of suspension/termination
Statement of risks
Possible additional costs to the subject
Whom to contact
Investigator statement (FDA 1572)
Investigator non-compliance
Records of receipt, shipment, disposition
Monitoring investigations
Changes in research
Study director: all data recorded and verified
Facility: article mixture storage areas

Equipment: appropriate design and adequate capacity
SOPs: authorization and documentation of deviations
SOPs: availability
Final report: circumstances affecting data qual.,

integrity
Final report: storage locations
Archives: records not retained as originals, true copies
Conflict of interest
Information given to subjects
Records of continuing review
Emergency use and IRB approval
Children as subjects
Statement of research, purpose, duration of

participation
Confidentiality, FDA inspection of records
Participation; refusal and discontinuance
Bioequivalence samples
Records of unused drug disposition

Exculpatory language, waiving of rights
Notifying contractor of GLP status
Management: testing of test and control articles
Study director: unforeseen circumstances
Study director: test system specified in protocol
Study director: follow GLP regulations
Study director: transfer of data to archives
QAU: separate and independent
QAU: inspect study at adequate intervals
QAU: problems affecting study integrity
QAU: SOPs and required records
Facility: supply storage areas
Equipment: inspection, cleaning and maintenance
Equipment: maintenance SOPs
Equipment: maintenance records
SOPs: historical file
Reagents: outdated
Animal care: feed and water analysis records
Test article: storage container labeling
Mixtures: uniformity and concentration
Protocol: experimental design
Protocol: approval of changes
Conduct: changes not obscuring original entries
Conduct: identification of individual inputting data
Final report: names of those involved
Final report: reports of individual scientists
Final report: statement by QAU
Final report: corrections or additions
Archives: reference other storage locations
Archives: individual responsible
Archives: unauthorized personnel
One non-affiliate member
Invited individual allowed to vote with IRB
Risks to subjects reasonable
Prompt reporting of changes

Provisions for soliciting assent and permission
Adequate assent of children; items to consider
Documentation of permission by parents or guardian
Access to records
Exception for informed consent; minimal risk study
Copy of consent form not provided
Number of subjects in study
Consequences of withdrawing
Benefits to the subject
Alternate procedures, courses of treatment
Shipment to unauthorized persons
New observations, adverse effects and risks
Unused drug disposition (sponsor)
Controlled substances (investigator)
FDA access to clinical investigator records
Unauthorized recipients (investigator)

Foreign clinical trials
Record retention requirement
Reporting
Risks minimized by using procedures already being

performed
Approval from a majority of members present
Significant new findings
Termination by investigator
Compensation, medical treatment in event of injury
Circumstances of obtaining consent
Changes in contact or chairperson information

Long Description
An investigation was not conducted in accordance with the [signed statement of investigator]
[investigational plan]. Specifically***
Failure to prepare or maintain [adequate] [accurate] case histories with respect to [observations and data
pertinent to the investigation] [informed consent]. Specifically, ***
Minutes of IRB meetings have not been [prepared] [maintained] in sufficient detail to show [attendance
at the meetings] [actions taken by the IRB] [the vote on actions, including the number of members voting
for, against and abstaining] [the basis for requiring changes in or disapproving research] [a written
summary of the discussion of controverted issues and their resolution]. Specifically, ***
Investigational drug disposition records are not adequate with respect to [dates] [quantity] [use by
subjects]. Specifically, ***
The IRB [has no] [did not follow its] written procedure for conducting its [initial] [continuing] review of
research. Specifically, ***
A list of IRB members has not been [prepared] [maintained], identifying members by [name] [earned
degrees] [representative capacity] [indications of experience sufficient to describe each member's chief
anticipated contribution to IRB deliberations] [any employment or other relationship between each
member and the institution]. Specifically, ***
Informed consent was not properly documented in that the written informed consent used in the study
[was not approved by the IRB] [was not signed by the subject or the subjects legally authorized
representative at the time of consent ] [was not dated by the subject or the subject's legally authorized
representative at the time of consent]. Specifically, ***
Failure to report promptly to the IRB all unanticipated problems involving risk to human subjects or
others. Specifically, ***
Failure to [select qualified investigators] [provide investigators with the information needed to conduct
the study properly] [ensure proper monitoring of the study] [ensure the study is conducted in accordance
with the protocol and/or investigational plan] [ensure that FDA and all investigators are promptly
informed of significant new adverse effects or risks]. Specifically, ***
Failure to obtain informed consent in accordance with 21 CFR Part 50 from each human subject prior to
[drug administration] [conducting study-related tests] . Specifically***
For other than expedited reviews, the IRB does not always review proposed research at convened
meetings at which a majority of the members of the IRB are present, including at least one member
whose primary concerns are in nonscientific areas. Specifically, ***
Legally effective informed consent was not obtained from a subject or the subject's legally authorized
representative, and the situation did not meet the criteria in 21 CFR 50.23 - 50.24 for exception.
Specifically, ***
Documentation has not been [prepared] [maintained] of written procedures for the IRB, as required by
21 CFR 56.108(a) and (b). Specifically, ***
The IRB does not conduct continuing review of research at intervals [appropriate to the degree of risk] [of
not less than once per year]. Specifically, ***
The IRB has not promptly notified in writing [the investigator] [the institution] when the IRB has
[approved] [disapproved] [required modifications to secure IRB approval of] proposed research activity.
Specifically, ***
Failure to report [promptly] to the sponsor adverse effects that may reasonably be regarded as caused by,
or probably caused by, an investigational drug. Specifically, ***
The IRB [has no] [did not follow its] written procedure for reporting its [findings] [actions] to the
[investigator] [institution]. Specifically, ***
The quality assurance unit failed to maintain a copy of a master schedule sheet that contained all
required elements for all nonclinical laboratory studies conducted by the testing facility. Specifically, ***
The IRB used an expedited review procedure to review supposedly minor changes to previously-approved
research, but the changes were not minor in nature. Specifically, ***
Copies have not been maintained of all correspondence between the IRB and the investigators.
Specifically, ***
The IRB approved the conduct of research involving children as subjects, but did not determine that the
research was in compliance with 21 CFR 50 Subpart D. Specifically, ***
The informed consent document lacked a description of reasonably foreseeable risks or discomforts to
the subject. Specifically, ***
Testing facility management failed to assure that all personnel clearly understood the functions they were
to perform. Specifically, ***
The quality assurance unit failed to determine whether any deviations from approved protocols or
standard operating procedures had been made with proper authorization and documentation.
Specifically, ***
The IRB is not composed of at least five members [with varying backgrounds to promote complete and
adequate review of research activities commonly conducted by the institution]. Specifically, ***
Copies have not been [prepared] [maintained] of all [research proposals reviewed] [scientific evaluations,
if any, accompanying research proposals] [approved sample consent documents] [progress reports
submitted by investigators] [reports of injuries to subjects]. Specifically, ***
Records required by 21 CFR 56 have not been maintained for three years following completion of the
research. Specifically, ***
The IRB [has no] [did not follow] written procedures for ensuring prompt reporting to [the IRB]
[appropriate institutional officials] [the FDA] of any instance of serious or continuing noncompliance with
theses regulations or the requirements or determinations of the IRB. Specifically, ***
The IRB [has no] [did not follow its] written procedure for determining which projects [require review
more often than annually] [need verification from sources other than the investigator that no material
changes have occurred since previous IRB review] . Specifically, ***
Transfer of obligations to a contract research organization [was not described in writing] [did not describe
each of the obligations assumed by the contract research organization, where not all obligations were
assumed]. Specifically, ***
Failure to assure that an IRB [complying with applicable regulatory requirements] was responsible for the
initial and continuing review and approval of a clinical study. Specifically, ***
The IRB used an expedited review procedure for research which did not appear in an FDA list of
categories eligible for expedited review, and which had not previously been approved by the IRB [within
one year]. Specifically, ***
Not all individuals engaged in the conduct of or responsible for the supervision of a nonclinical laboratory
study have education, training, and experience, or combination thereof, to enable that individual to
perform assigned functions. Specifically, ***
The study director failed to assure that the protocol, including any change, was approved and was
followed. Specifically, ***
Not all equipment used for the generation, measurement, or assessment of data is adequately tested,
calibrated and/or standardized. Specifically, ***
Standard operating procedures have not been established for [animal room preparation] [animal care]
[receipt, identification, storage, handling, mixing, and method of sampling of the test and control articles]
[test system observations] [laboratory tests] [handling of animals found moribund or dead during study]
[necropsy of animals or postmortem examination of animals] [collection and identification of specimens]
[histopathology] [data handling, storage, and retrieval] [maintenance and calibration of equipment]
[transfer, proper placement, and identification of animals]. Specifically, ***
Not all nonclinical laboratory studies were conducted in

accordance with the protocol. Specifically, ***
Not all [raw data] [documentation] [protocols] [final reports] [specimens (except those specimens
obtained from mutagenicity tests and wet specimens of blood, urine, feces, and biological fluids)]
generated as a result of a nonclinical laboratory study were retained. Specifically, ***
The IRB uses an expedited review procedure, but [has not adopted] [is not following] a method for
keeping members advised of research proposals which have been approved under the procedure.
Specifically, ***
The IRB approved a clinical investigation in which more than minimal risk to children was presented by 1)
an intervention or procedure that held out the prospect of direct benefit for the individual subjects,
and/or 2) by a monitoring procedure which was likely to contribute to the individual subjects' well-being.
However, the IRB did not [find] [document] that [the risk was justified by the anticipated benefit to the
subjects] [the relation of the anticipated benefit to the risk was at least as favorable to the subjects as
that presented by available alternative approaches] [adequate provisions had been made for soliciting
the assent of the children and the permission of their parents or guardians, as set forth in 21 CFR 50.55].
Specifically, ***
Failure to ensure that an investigation was conducted in accordance with the general investigational plan
and protocols as specified in the IND. Specifically, ***
Investigational records were not retained for a period of two years following [approval of a drug's
marketing application] [discontinuance of the investigation and notification of FDA]. Specifically, ***
The general requirements for informed consent were not met in that the information given was not in
language understandable to the subject or the subject's representative. Specifically, ***
The quality assurance unit did not monitor each study to assure management that the facilities,
equipment, personnel, methods, practices, records, and controls were in conformance with FDA GLP
regulations. Specifically, ***
The quality assurance unit failed to review the final study report to assure that such report accurately
described the methods and standard operating procedures, and that the reported results accurately
reflected the raw data of the study. Specifically, ***
The testing facility does not have written standard operating procedures setting forth nonclinical
laboratory study methods that management is satisfied are adequate to insure the quality and integrity of
the data generated in the course of a study. Specifically, ***
Not all data entries were dated on the date of entry and signed or initialed by the person entering the
data. Specifically, ***
The informed consent document did not contain [a description of the procedures to be followed]
[identification of any procedures which were experimental]. Specifically, ***
[appropriate institutional officials] [the FDA] of any unanticipated problems involving risks to human
subjects or others. Specifically, ***
[appropriate institutional officials] [the FDA] of any suspension or termination of IRB approval .
Specifically, ***
The informed consent document did not contain a statement that the test article or procedure might
involve risks to the subject (or to the embryo or fetus, if the subject is or may become pregnant) that are
currently unforeseeable. Specifically, ***
The informed consent document did not include a statement of any additional costs to the subject that
might result from participation in the research, as appropriate. Specifically, ***
The informed consent document lacked an explanation of whom to contact [for answers to pertinent
questions about the research and research subjects' rights] [in the event of a research-related injury to
the subject]. Specifically, ***
Failure to obtain [an] [a complete] investigator statement, form FDA-1572, before permitting an
investigator to participate in an investigation. Specifically, ***
An investigator who did not comply with [the signed agreement] [the general investigational plan]
[applicable regulatory requirements] was not [promptly brought into compliance] [terminated].
Specifically, ***
Lack of [adequate] records covering [receipt] [shipment to investigators] [disposition] of an investigational
drug. Specifically, ***
Failure to monitor the progress of an investigation conducted under your IND. Specifically, ***
Not all changes in research activity were approved by an Institutional Review Board prior to
implementation. Specifically, ***
The study director failed to assure that all experimental data, including observations of unanticipated
responses of the test system, were accurately recorded and verified. Specifically, ***
The testing facility does not provide separate areas, as necessary, to prevent contamination or mix-ups for
storage of the test and control article mixtures. Specifically, ***
Not all [equipment used in the generation, measurement, or assessment of data] [equipment used for
facility environmental control] is of appropriate design and adequate capacity to function according to
the protocol and is suitably located for operation, inspection, cleaning, and maintenance. Specifically,
***
Not all deviations from standard operating procedures in a study were authorized by the study director
and documented in the raw data. Specifically, ***
Not all laboratory areas have immediately available laboratory manuals and standard operating
procedures relative to the laboratory procedures being performed. Specifically, ***
The final study report did not include a description of all circumstances that may have affected the quality
or integrity of the data. Specifically, ***
The final study report did not include the locations where all [specimens] [raw data] [the final report] are
to be stored. Specifically, ***
Not all required records were retained as original records or as true copies of the original records.
Specifically, ***
The IRB allowed a member to participate in the IRB's [initial] [continuing review] of a project in which the
member had a conflicting interest. Specifically, ***
The IRB does not require that information given to subjects as part of informed consent contain all
necessary elements of informed consent. Specifically, ***:
Records have not been [prepared] [maintained] of all continuing review activities. Specifically, ***
A clinical investigator did not report to the IRB [, within five days of use,] the emergency use of a test
article for which the IRB had not reviewed the research proposal. Specifically, ***
The IRB did not determine [at the time of initial review] [at the time of continuing review for an on-going
study which was started on/before April 30, 2001] that a study was in compliance with 21 CFR Part 50
Subpart D, "Additional Safeguards for Children in Clinical Investigations." Specifically, ***
The informed consent document did not contain [a statement that the study involved research] [an
explanation of the purposes of the research, and the expected duration of the subject's participation].
Specifically, ***
There was no statement in the informed consent document that [described the extent, if any, to which
confidentiality of records identifying the subject would be maintained] [noted the possibility that the
Food and Drug Administration might inspect the records]. Specifically, ***
The informed consent document did not contain a statement that [participation was voluntary] [refusal to
participate would involve no penalty or loss of benefits to which the subject was otherwise entitled] [the
subject might discontinue participation at any time without penalty or loss of benefits to which the
subject was otherwise entitled]. Specifically, ***
Samples of the [test article] [reference standard] used in a [bioavailability] [bioequivalence] study were
not [retained] [released to FDA upon request as required by 21 CFR Part 320.138]. Specifically, ***
Failure to maintain [adequate] written records of the disposition of an investigational drug in accordance
with 21 CFR Part 312.57. Specifically, ***
The general requirements for informed consent were not met in that the consent form contained
exculpatory language [through which the subject or the subject's representative was made to waive or
appear to waive some of the subject's legal rights] [that released or appeared to release the investigator,
sponsor, the institution, or its agents from liability for negligence]. Specifically, ***
Not all consulting laboratories, contractors, or grantees were notified that the study must be conducted
in compliance with FDA GLP regulations. Specifically, ***
Testing facility management failed to assure that all test and control articles or mixtures had been
appropriately tested for identity, strength, purity, stability, and uniformity, as applicable. Specifically, ***
The study director failed to assure that unforeseen circumstances that might affect the quality and
integrity of the nonclinical laboratory study were noted when they occurred and corrective action was
taken and documented. Specifically, ***
The study director failed to assure that test systems were as specified in the protocol. Specifically, ***
The study director failed to assure that all applicable GLP regulations were followed. Specifically, ***
The study director failed to assure that all raw data, documentation, protocols, specimens, and final
reports were transferred to the archives during or at the close of the study. Specifically, ***
The quality assurance unit, for any given study, was not entirely separate from and independent of the
personnel engaged in the direction and conduct of that study. Specifically, ***
The quality assurance unit failed to inspect each nonclinical laboratory study at intervals adequate to
assure the integrity of the study and maintain written and properly signed records of each periodic
inspection. Specifically, ***
The quality assurance unit failed to immediately bring to the attention of the study director and
management any problems found during the course of an inspection which are likely to affect study
integrity. Specifically, ***
The quality assurance unit failed to maintain and make available for inspection required records regarding
its responsibilities and procedures and the method of indexing such records. Specifically, ***
The testing facility does not provide storage areas, as needed, for feed, bedding, supplies, and
equipment. Specifically, ***
Not all equipment is adequately inspected, cleaned, and maintained. Specifically, ***
The standard operating procedures for routine inspection, cleaning, maintenance, testing, calibration,
and/or standardization of equipment are not adequate. Specifically, ***
Adequate written records are not maintained of all equipment inspection, maintenance, testing,
calibrating and/or standardizing operations. Specifically, ***
A historical file of standard operating procedures, and all revisions, including the dates of such revisions,
was not maintained. Specifically, ***
Deteriorated or outdated reagents and solutions were used. Specifically, ***

Not all feed and water analyses for contaminants were maintained as raw data. Specifically, ***.
Not all storage containers for a test or control article were labeled by name, chemical abstract number or
code number, batch number, expiration date, if any, and, where appropriate, storage conditions necessary
to maintain the identity, strength, purity, and composition of the test or control article. Specifically, ***
Not all test or control articles mixed with a carrier were tested by appropriate analytical methods to
determine [the uniformity of the mixture] [periodically, the concentration of the test or control article in
the mixture]. Specifically, ***
Not all protocols contained a description of the experimental design, including the methods for the
control of bias. Specifically, ***
Not all changes in, or revisions of, an approved protocol and the reasons therefore were documented,
signed by the study director, dated, and maintained with the protocol. Specifically, ***
Not all changes in entries were made so as not to obscure the original entry, indicated the reason for such
change, and were dated and signed or identified at the time of the change. Specifically, ***
In automated data collection systems, the individual responsible for direct data input was not identified
at the time of data input. Specifically, ***
The final study report did not include [the name of the study director] [the names of other scientists or
professionals] [the names of all supervisory personnel] involved in the study. Specifically, ***
The final study report did not include the signed and dated reports of each of the individual scientists or
other professionals involved in the study. Specifically, ***
The final study report did not include the statement prepared and signed by the quality assurance unit as
required by FDA Good Laboratory Practice regulations. Specifically, ***
Not all corrections or additions to a final report were in the form of an amendment by the study director.
Specifically, ***
The testing facility archive failed to specifically reference other locations where raw data or specimens are
stored. Specifically, ***
An individual was not identified as responsible for the archives. Specifically, ***
Unauthorized personnel entered the archives. Specifically, ***
The IRB does not include at least one member who is not otherwise affiliated with the institution, and
who is not part of the immediate family of a person who is affiliated with the institution. Specifically, ***
The IRB invited an individual with competence in a special area to assist in the review of complex issues
which required expertise beyond or in addition to that available on the IRB; however, the IRB allowed the
individual to vote with the IRB. Specifically, ***
The IRB approved the conduct of research, but did not determine that the risks to subjects were
reasonable in relation to the anticipated benefits (if any) to subjects, and to the importance of the
knowledge that might be expected to result. Specifically, ***
The IRB [has no] [did not follow its] written procedure for ensuring prompt reporting to the IRB of
changes in research activity. Specifically, ***
For a clinical investigation in which no greater than minimal risk to children as subjects was presented,
the IRB did not [find] [document] that adequate provisions had been made for [soliciting the assent of
the children] [soliciting the permission of the parents or guardians of the children] as set forth at 21 CFR
50.55. Specifically, ***
The IRB did not take into consideration the [ages] [maturity] [psychological state] of the children involved
in a clinical investigation when the IRB was determining whether those children were capable of
providing assent. Specifically, ***
Permission by parents or guardians for the participation of children as subjects in a clinical investigation
was not documented in accordance with and to the extent required by 21 CFR 50.27. Specifically, ***
Records required to be maintained under 21 CFR 56 were not accessible for [inspection] [copying] by
authorized representatives of the FDA. Specifically, ***
The IRB waived the requirement for a written consent form signed by the [subject] [subject's legally
authorized representative], without first determining the research [presented no more than minimal risk
of harm to subjects] [involved no procedure for which written consent was normally required outside the
research context]. Specifically, ***
A copy of the written consent form which had been approved by the IRB and signed and dated by the
subject or the subject's legally authorized representative, was not provided to the subject or the subject's
legally authorized representative at the time of consent. Specifically, ***
The informed consent document did not state the approximate number of subjects involved in the study.
Specifically, ***
The informed consent document did not provide information regarding the consequences of a subject's
decision to withdraw from the research, and procedures for orderly termination of participation by the
subject. Specifically, ***
A description of any benefits [to the subject] [to others] which might reasonably be expected from the
research was not included in the informed consent document. Specifically, ***
There was [no] [an incomplete] disclosure in the informed consent document of appropriate alternate
procedures or courses of treatment, if any, that might be advantageous to the subject. Specifically, ***
Shipment of an investigational new drug to someone not an investigator participating in the investigation.
Specifically, ***
Not all participating investigators were [promptly] informed of new observations discovered by or
reported to the sponsor [with respect to adverse effects and safe use]. Specifically, ***
Failure to assure the return or other disposition of all unused supplies of an investigational drug from
each individual investigator whose participation in the investigation was discontinued or terminated.
Specifically, ***
Inadequate precautions to prevent theft or diversion with respect to [storage of] [access to] an
investigational drug which is a controlled substance. Specifically, ***
Failure to permit an authorized officer or employee of FDA to [have access to] [copy] [verify] records or
reports. Specifically, ***
A study drug was [administered to subjects] [provided to persons] not under the investigator's personal
supervision or under the supervision of a subinvestigator responsible to the investigator. Specifically, ***
Failure to assure that foreign clinical research was conducted in accordance with [the ethical principles
stated in the ``Declaration of Helsinki''] [the laws and regulations of the country in which the research
was conducted]. Specifically, ***
Records and reports were not retained for two years after [marketing application approval]
[discontinuance of the investigation and notification of FDA]. Specifically***
The IRB's [suspension] [termination of approval] for research was not reported [promptly] to [the
investigator] [appropriate institutional officials] [the Food and Drug Administration]. Specifically, ***
The IRB approved the conduct of research, but did not determine that risks to subjects were minimized,
whenever appropriate, by using procedures already being performed on the subjects for diagnostic or
treatment purposes. Specifically, ***
For other than expedited reviews, research approved by the IRB does not always receive the approval of a
majority of those IRB members present. Specifically, ***
The informed consent document did not include a statement that significant new findings developed
during the course of the research, which might relate to the subject's willingness to continue
participation, would be provided to the subject. Specifically, ***
The informed consent document did not include a statement of anticipated circumstances under which
the subject's participation might be terminated by the investigator, without regard to the subject's
consent. Specifically, ***
For research involving more than minimal risk, the informed consent document lacked an explanation as
to whether any [compensation] [medical treatments] were available if injury occurred, and, if so, [of what
they consisted] [where further information might be obtained]. Specifically, ***
The general requirements for informed consent were not met in that [you] [the investigator] did not seek
consent under circumstances that [provided the prospective subject or the subject's representative
sufficient opportunity to consider whether or not to participate] [minimized the possibility of coercion or
undue influence]. Specifically, ***
The IRB did not revise its registration information with respect to changes in [the contact person] [the
chairperson] within 90 days of the change. Specifically, ***
Frequency
129
85
30
24
23
19
18
15
14
14
12
8
8
5
5
4
3
2
2
2
2
1
1
1
1
1
1
1
Devices 3130 21 CFR 820.100(a)
Devices 14713 21 CFR 820.198(a)
Devices 3696 21 CFR 820.100(b)
Devices 546 21 CFR 820.75(a)
Devices 630 21 CFR 803.17
Devices 3282 21 CFR 820.90(a)
Devices 3103 21 CFR 820.30(i)
Devices 3331 21 CFR 820.181

Devices 2327 21 CFR 820.22
Devices 14712 21 CFR 820.184
Devices 3125 21 CFR 820.80(d)
Devices 3172 21 CFR 820.198(c)
Devices 2350 21 CFR 820.25(b)
Devices 3101 21 CFR 820.30(g)
Devices 3168 21 CFR 820.198(a)
Devices 14722 21 CFR 820.40
Devices 3666 21 CFR 820.20(c)
Devices 2371 21 CFR 820.30(a)
Devices 3680 21 CFR 820.70(a)
Devices 3160 21 CFR 820.184
Devices 3678 21 CFR 820.30(g)
Devices 3159 21 CFR 820.184

Devices 3233 21 CFR 820.72(a)
Devices 3121 21 CFR 820.80(b)
Devices 541 21 CFR 820.70(c)
Devices 732 21 CFR 803.50(a)(2)
Devices 3120 21 CFR 820.80(a)
Devices 3415 21 CFR 820.22
Devices 3118 21 CFR 820.75(a)
Devices 3127 21 CFR 820.80(e)
Devices 3375 21 CFR 820.198(e)

Devices 2650 21 CFR 820.30(f)
Devices 3104 21 CFR 820.30(j)
Devices 3128 21 CFR 820.90(a)
Devices 4059 21 CFR 820.22
Devices 2328 21 CFR 820.22
Devices 3669 21 CFR 820.20(c)
Devices 539 21 CFR 820.70(b)
Devices 419 21 CFR 820.20(b)
Devices 537 21 CFR 820.70(a)
Devices 3427 21 CFR 820.50(a)(2)
Devices 2604 21 CFR 820.30(e)

Devices 3117 21 CFR 820.70(i)
Devices 3837 21 CFR 820.25(b)
Devices 486 21 CFR 820.50(a)
Devices 731 21 CFR 803.50(a)(1)
Devices 2968 21 CFR 812.100
Devices 2974 21 CFR 812.110(b)
Devices 3123 21 CFR 820.80(c)
Devices 3132 21 CFR 820.120
Devices 3426 21 CFR 820.50(a)(1)
Devices 14716 21 CFR 820.30(f)
Devices 14720 21 CFR 820.50(a)(3)
Devices 3345 21 CFR 820.200(a)
Devices 4191 21 CFR 806.10(a)(1)
Devices 2302 21 CFR 820.20(e)
Devices 3285 21 CFR 820.90(b)(2)
Devices 631 21 CFR 803.17(a)(1)
Devices 2430 21 CFR 820.30(b)
Devices 2557 21 CFR 820.30(c)
Devices 3286 21 CFR 820.90(b)(1)
Devices 14710 21 CFR 820.150
Devices 3102 21 CFR 820.30(h)
Devices 3170 21 CFR 820.198(b)
Devices 3263 21 CFR 820.250(b)

Devices 3201 21 CFR 820.40(a)
Devices 14505 21 CFR 812.140(a)(3)
Devices 3119 21 CFR 820.75(b)
Devices 3226 21 CFR 820.70(g)(1)
Devices 3269 21 CFR 820.80(b)
Devices 632 21 CFR 803.17(a)(2)
Devices 3108 21 CFR 820.70(e)
Devices 3207 21 CFR 820.50(b)
Devices 3671 21 CFR 820.25(a)
Devices 3262 21 CFR 820.250(a)
Devices 3266 21 CFR 820.86
Devices 3433 21 CFR 820.75(c)
Devices 4070 21 CFR 820.30(g)
Devices 14714 21 CFR 820.30(c)
Devices 3676 21 CFR 820.30(f)
Devices 454 21 CFR 820.40(a)
Devices 2984 21 CFR 812.140(a)(3)(i)
Devices 3313 21 CFR 820.120(d)
Devices 3425 21 CFR 820.50(a)(1)
Devices 3432 21 CFR 820.75(b)(2)

Devices 4189 21 CFR 820.198(a)
Devices 14711 21 CFR 820.160(a)
Devices 2293 21 CFR 820.20(d)
Devices 3171 21 CFR 820.198(b)
Devices 3191 21 CFR 820.30(g)
Devices 3192 21 CFR 820.30(g)
Devices 3199 21 CFR 820.40(a)
Devices 3204 21 CFR 820.40(b)
Devices 3231 21 CFR 820.70(i)
Devices 3235 21 CFR 820.72(a)
Devices 3270 21 CFR 820.80(c)
Devices 3683 21 CFR 820.70(g)
Devices 14715 21 CFR 820.30(d)
Devices 2269 21 CFR 820.20(a)
Devices 2630 21 CFR 820.30(e)
Devices 2981 21 CFR 812.140(a)(2)(i)
Devices 3264 21 CFR 820.250(b)
Devices 3668 21 CFR 820.20(c)
Devices 4212 21 CFR 806.20(b)(4)

Devices 633 21 CFR 803.17(a)(3)
Devices 2970 21 CFR 812.100
Devices 3173 21 CFR 820.198(d)
Devices 3203 21 CFR 820.40(b)
Devices 3206 21 CFR 820.50(b)
Devices 3232 21 CFR 820.72(a)
Devices 3677 21 CFR 820.30(g)
Devices 3686 21 CFR 820.90(b)(2)
Devices 14507 21 CFR 812.140(a)(3)(ii)
Devices 14718 21 CFR 820.30(g)
Devices 14719 21 CFR 820.30(h)
Devices 636 21 CFR 803.17(b)(2)
Devices 3139 21 CFR 820.140
Devices 3149 21 CFR 820.180
Devices 3190 21 CFR 820.30(g)
Devices 3237 21 CFR 820.72(b)
Devices 3310 21 CFR 820.120(b)
Devices 3409 21 CFR 820.200(d)
Devices 4057 21 CFR 820.20(a)
Devices 635 21 CFR 803.17(b)(1)

Devices 3138 21 CFR 820.130
Devices 3147 21 CFR 820.170(a)
Devices 3236 21 CFR 820.72(b)
Devices 14717 21 CFR 820.30(g)
Devices 733 21 CFR 803.50(b)(1)
Devices 3346 21 CFR 820.200(b)
Devices 3434 21 CFR 820.75(c)
Devices 3674 21 CFR 820.30(d)
Devices 3841 21 CFR 820.90(b)(2)
Devices 2431 21 CFR 820.30(b)
Devices 2648 21 CFR 820.30(f)
Devices 2985 21 CFR 812.140(a)(3)(ii)
Devices 2994 21 CFR 812.140(b)(3)
Devices 3064 21 CFR 812.140(a)(4)
Devices 3109 21 CFR 820.70(d)
Devices 3155 21 CFR 820.181(a)
Devices 3239 21 CFR 820.72(b)
Devices 3309 21 CFR 820.120(b)
Devices 3372 21 CFR 820.198(d)
Devices 4192 21 CFR 806.10(a)(2)
Devices 14721 21 CFR 820.70(g)(2)
Devices 2339 21 CFR 820.22

Devices 2628 21 CFR 820.30(e)
Devices 2910 21 CFR 812.7(a)
Devices 2928 21 CFR 812.40
Devices 2980 21 CFR 812.140(a)(1)
Devices 3007 21 CFR 812.140(d)
Devices 3111 21 CFR 820.70(f)
Devices 3113 21 CFR 820.70(g)
Devices 3115 21 CFR 820.70(h)
Devices 3175 21 CFR 820.186
Devices 3328 21 CFR 820.180(b)
Devices 3332 21 CFR 820.184(e)
Devices 14511 21 CFR 812.2(b)
Devices 14523 21 CFR 812.43(c)
Devices 538 21 CFR 820.70(a)
Devices 2338 21 CFR 820.22
Devices 2602 21 CFR 820.30(d)

Devices 2969 21 CFR 812.100
Devices 2973 21 CFR 812.110(a)
Devices 2983 21 CFR 812.140(a)(2)(iii)
Devices 2993 21 CFR 812.140(b)(2)
Devices 3027 21 CFR 812.150(a)(4)
Devices 3048 21 CFR 812.150(b)(5)
Devices 3049 21 CFR 812.150(b)(5)
Devices 3065 21 CFR 812.140(a)(5)
Devices 3193 21 CFR 820.30(g)
Devices 3198 21 CFR 820.40(b)
Devices 3200 21 CFR 820.40(a)
Devices 3291 21 CFR 820.100(b)
Devices 3323 21 CFR 820.170(b)
Devices 3343 21 CFR 820.198(e)
Devices 3672 21 CFR 820.30(c)
Devices 3692 21 CFR 820.100(a)(4)
Devices 7017 21 CFR 812.150(b)(7)

Devices 638 21 CFR 803.17(b)(4)
Devices 640 21 CFR 803.18(a)
Devices 642 21 CFR 803.18(b)(1)(i)
Devices 648 21 CFR 803.18(e)
Devices 649 21 CFR 803.18(e)
Devices 658 21 CFR 803.30(a)(2)
Devices 735 21 CFR 803.50(b)(2)
Devices 745 21 CFR 803.52(b)(2)
Devices 793 21 CFR 803.53(a)
Devices 2913 21 CFR 812.7(b)
Devices 2923 21 CFR 812.20(a)(1)
Devices 2930 21 CFR 812.42
Devices 2937 21 CFR 812.43(c)(1)
Devices 2940 21 CFR 812.43(c)(4)(i)
Devices 2966 21 CFR 812.66

Devices 2991 21 CFR 812.140(b)(1)
Devices 2995 21 CFR 812.140(b)(4)
Devices 2996 21 CFR 812.140(b)(4)(i)
Devices 2999 21 CFR 812.140(b)(4)(iv)
Devices 3000 21 CFR 812.140(b)(4)(v)
Devices 3001 21 CFR 812.140(b)(4)(vi)
Devices 3003 21 CFR 812.140(b)(6)
Devices 3021 21 CFR 812.150(a)(1)
Devices 3025 21 CFR 812.150(a)(3)
Devices 3028 21 CFR 812.150(a)(4)
Devices 3034 21 CFR 812.150(a)(6)
Devices 3038 21 CFR 812.150(b)(1)
Devices 3052 21 CFR 812.150(b)(6)
Devices 3054 21 CFR 812.150(b)(7)
Devices 3156 21 CFR 820.181(b)
Devices 3167 21 CFR 820.198(a)

Devices 3208 21 CFR 820.50(b)
Devices 3210 21 CFR 820.65
Devices 3283 21 CFR 820.90(a)

Devices 3347 21 CFR 820.200(c)
Devices 3355 21 CFR 820.198(f)
Devices 3371 21 CFR 820.198(a)(3)
Devices 3378 21 CFR 820.198(e)(4)
Devices 3383 21 CFR 820.198(g)
Devices 3414 21 CFR 820.200(d)(6)
Devices 3417 21 CFR 820.70(a)(2)
Devices 3682 21 CFR 820.70(d)
Devices 3688 21 CFR 820.100(a)(1)
Devices 4201 21 CFR 806.10(c)(8)
Devices 4202 21 CFR 806.10(c)(9)
Devices 4204 21 CFR 806.10(c)(11)
Devices 4207 21 CFR 806.10(d)
Devices 4208 21 CFR 806.20(a)
Devices 4210 21 CFR 806.20(b)(2)
Devices 4227 21 CFR 821.20(a)
Devices 4252 21 CFR 821.25(c)(3)
Devices 4278 21 CFR 821.50(a)
Devices 4430 21 CFR 803.18(d)(1)

Devices 4436 21 CFR 803.40(a)
Devices 7006 21 CFR 812.43(c)(5)
Devices 7012 21 CFR 812.100
Devices 14508 21 CFR 812.140(a)(4)
Devices 14513 21 CFR 812.2(c)(3)
Devices 14520 21 CFR 812.36(d)
Devices 14521 21 CFR 812.36(e)

Short Description
Lack of or inadequate procedures
Lack of or inadequate complaint procedures
Documentation
Lack of or inadequate process validation
Lack of Written MDR Procedures
Purchasing controls, Lack of or inadequate procedures
Nonconforming product, Lack of or inadequate

procedures
Design changes - Lack of or Inadequate Procedures
DMR - not or inadequately maintained

Quality audits - Lack of or inadequate procedures
DHR - not or inadequately maintained
Lack of or inadequate final acceptance procedures
Investigation of device failures
Training - Lack of or inadequate procedures
Design validation- Lack of or inadequate procedures
Complaints
Procedures not adequately established or maintained
Management review - Lack of or inadequate

procedures
Design control - no procedures
Process control procedures, Lack of or inadequate
procedures
Lack of or inadequate DHR procedures
Design Validation - Risk analysis not

performed/inadequate
DHR content
Calibration, Inspection, etc. Procedures Lack of or
Inadequ
Lack of or inadequate receiving acceptance procedures
Environmental control Lack of or inadequate

procedures
Report of Malfunction
Lack of or inadequate procedures - Acceptance

activities
Quality Audit/Reaudit - conducted
Documentation
Documentation
Records of complaint investigation

Lack of procedures, or not maintained
Design verification - Lack of or inadequate procedures
Design history file
Nonconforming product control
Quality Audits - defined intervals
Quality audits - auditor independence
Management review - defined interval, sufficient

frequency
Production and Process Change Procedures, lack of or

Inad.
Lack of or inadequate organizational structure
Production processes
Supplier oversight
Design review - Lack of or inadequate procedures

Software validation for automated processes
Training records
Evaluation of suppliers, contractors, etc., requirements
Report of Death or Serious Injury
Investigator non-compliance with

agreement/plan/regulations
Investigator non-compliance with

agreement/plan/regulations
Lack of or inadequate In-process acceptance

procedures
Lack of or inadequate procedures for labeling
Documented evaluation
Design verification - output does not meet input

requirement
Acceptable supplier records, inadequate records
Servicing - Lack of or inadequate procedures
Report of risk to health
Quality System Procedures

Product rework procedures, Lack of or inadequate
procedures
Lack of System for Event Evaluations
Design plans - Lack of or inadequate
Design input - documentation

Procedures for product review,disposition lack
of/inadequate
Lack of or inadequate procedures for storage.
Design transfer - Lack of or inadequate procedures
Review and evaluation for investigation
Sampling plans
Not approved or obsolete document retrieval
Investigator's subject records inadequate
Lack/Inad procedure-Monitoring/Control of Validated

Proces
Maintenance schedule, Lack of or inadequate schedule
Incoming acceptance records, documentation
Lack of System for Determining MDR Events
Contamination control, Lack of or inadequate

procedures
Supplier notification of changes
Personnel
Statistical techniques - Lack of or inadequate

procedures
Acceptance status
Process changes - review, evaluation and revalidation
Design validation - documentation
Design input - Lack of or inadequate procedures
Design verification - documentation
Document review, approval by designated individual
Investigator records of informed consent inadequate
Records, DHR {see also 820.184(e)}
Evaluation and Selection, Suppliers, Contractors, etc.
Documentation of validated process performance

General
Lack of or inadequate procedures for distribution
Quality plan
Rationale documented for no investigation
Design validation - production units
Design validation - user needs and intended uses
Document review, approval documentation
Change records, content
Documentation of software validation
Equipment control activity documentation
Documentation
Equipment Installation, Placement, Specified

Requirements
Design output - Lack of or inadequate procedures
Submission Within One Month
Quality policy and objectives
Design review - documentation
Investigator device accountability inadequate
Sampling methods - Lack of or inadequate procedures
Management review dates
Justification for not reporting
Identification procedures, Lack of or inadequate

procedures
Lack of System for Timely Submission of Reports
Investigator lack of informed consent
Evaluation, timeliness, identification
Document change records, maintained.
Approval, inadequate purchasing data
Equipment suitability & capability
Design validation - software validation not performed
Product rework documentation, DHR {see also 820.184}
Investigator adverse effect records inadequate
Design validation - Risk analysis
Incorrect translation to production specifications
Reports and information documentation
Lack of or inadequate procedures for handling
Availability
Design validation acceptance criteria
Remedial action
DHR documentation of label release {see also 820.184}
Service reports
Management ensuring quality policy is understood
Info evaluated to determine if event was reportable

Packaging
Lack of or inadequate instructions
Calibration procedures - content
Design validation - software validation documentation
Reporting Information Reasonably Known
Analyzing service report

Documentation - review in response to changes or
deviations
Design output - documentation
Product rework adverse effects {see also 820.184}
Design plans- updated
Design verification procedures
Investigator records of relevant observations

inadequate
Sponsor records of investigator agreements inadequate
Investigator protocol records inadequate
Personnel requirements, Lack of or inadequate

requirements
DMR device specifications
Remedial action - documentation
Examination for accuracy
Records of MDR Investigation
Report of violation of the Act (see 803.52(e)(9))
Periodic equipment inspections
Quality Audit/Reaudit - documentation

Design review procedures - personnel
Promotion or test marketing
Sponsors' general responsibilities
Investigator correspondence records inadequate
Record retention inadequate
Buildings
Equipment design and installation
Use and removal, Lack of or inadequate procedures
QSR
Retention period
ID label, labeling
Abbreviated requirements / non-significant risk study
No investigator agreement
Process control procedures
Quality audit - audit report review
Design output - review and approval

No investigator protection - subject rights, safety,
welfare
Subject participation prior to study approval
Investigator records of disposition of devices

inadequate
Sponsor device disposition records inadequate
Investigator non-emergency safety or soundness

changes
Sponsor progress reports for non-significant risk study
Sponsor progress reports for significant risk study
Additional investigator records FDA requires
Design validation - simulated testing
Document changes, review and approval,

communication
Document locations, Dissemination, etc.
Procedures
Installer records
Maintained
Design input - review and approval
CAPA verification/validation of corrective/preventive

action
Sponsor final report for non-significant risk study
Failure to use FDA Form 3500A

Info which facilitates timely FDA follow-up
Event files--failure to establish
Adverse events--all info not in file
MDR not evaluated per 820.162 and 820.198
Info not obtained or submitted
Report of Serious Injury Within 10 Days
Explanation of Incomplete Information
Death
Firm Did Not Submit 5 Day Report
Commercialization
Did not submit IDE application to FDA
Sponsor began study before IRB/FDA approval
No curriculum vitae in investigator agreement
No investigation agreement statement of commitment
No IRB notification of significant risk determination

Sponsor correspondence records inadequate
Availability of records of non-significant risk studies
Sponsor records re device use in non-significant risk

study
Sponsor records of non-significant risk study IRBs
Sponsor records re QSR/GMP & non-significant risk

studies
Sponsor lack of other FDA-required info
Other sponsor records required by FDA inadequate
Investigator report of unanticipated adverse effects
No investigator progress reports
No approval for investigator change in non-emergency
Investigator final report
Sponsor evaluation rpt not timely, distributed
Sponsor notif. of rqst. to return/repair/dispose not

made
30-day sponsor notification to FDA
DMR production process specifications
Complete files maintained

Approval of purchasing data {see also 820.40(a)}
Documentation of control numbers {see also 820.184}
Specific non-conforming product procedures

Service reports/MDRs/complaints
Records accessibility
Processing MDRs {see also 803, 804}
Complainant data
Foreign complaint files
Test and inspection data
Production monitoring and control
Implementing Personnel Procedures, Health,

Cleanliness.
Analysis of data/reports from data sources
Illness report
Device number, identification
Domestic & foreign consignees
Notification of extended action
Records not kept
Device model identification
Failure to track
Quality assurance procedures: 6-month & annual audits
Not available for inspection
Distributor responsibilities for records

Report of death, injury by marketed device
No financial disclosure info in investigator agreement
Investigator lack of control of investigational devices
Investigator record of protocol deviations inadequate
Needs IDE; diagnostic device exemption conditions not

met
No FDA approval for treatment IDE
No IRB approval for treatment use

Long Description
Procedures for corrective and preventive action have not been [adequately] established. Specifically, ***
Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit have not
been [adequately] established. Specifically,***
Corrective and preventive action activities and/or results have not been [adequately] documented.
Specifically, ***
A process whose results cannot be fully verified by subsequent inspection and test has not been
[adequately] validated according to established procedures. Specifically, ***
Written MDR procedures have not been [developed] [maintained] [implemented]. Specifically, ***
Procedures to ensure that all purchased or otherwise received product and services conform to specified
requirements have not been [adequately] established. Specifically, ***
Procedures have not been [adequately] established to control product that does not conform to specified
requirements. Specifically, ***
Procedures for design change have not been [adequately] established. Specifically,***
A device master record has not been [adequately] maintained. Specifically, ***
Procedures for quality audits have not been [adequately] established. Specifically, ***
A device history record has not been [adequately] maintained. Specifically, ***
Procedures for finished device acceptance have not been [adequately] established. Specifically, ***
Complaints involving the possible failure of [a device] [labeling] [packaging] to meet any of its
specifications were not [reviewed] [evaluated] [investigated] where necessary. Specifically, ***
Procedures for training and identifying training needs have not been [adequately] established.
Specifically, ***
Procedures for design validation have not been [adequately] established. Specifically,***
Complaint files are not [adequately] maintained. Specifically ***
Document control procedures have not been adequately [established] [maintained]. Specifically,***
Procedures for management review have not been [adequately] established. Specifically,***
Procedures for design control have not been established. Specifically,***

Process control procedures that describe any process controls necessary to ensure conformance to
specifications have not been [adequately] established. Specifically, ***
Procedures for device history records have not been [adequately] established. Specifically,***
Risk analysis [was not performed] [is inadequate] [is incomplete]. Specifically, ***
The device history record does not demonstrate that the device was manufactured in accordance with
[the device master record] [21 CFR 820].
Procedures to ensure equipment is routinely [calibrated] [inspected] [checked] [maintained] have not
been [adequately] established. Specifically, ***
Procedures for acceptance of incoming product have not been [adequately] established. Specifically, ***
Procedures to control environmental conditions have not been [adequately] established. Specifically, ***
An MDR report was not submitted within 30 days of receiving or otherwise becoming aware of
information that reasonably suggests that a marketed device has malfunctioned and would be likely to
cause or contribute to a death or serious injury if the malfunction were to recur. Specifically, ***
Procedures for acceptance activities have not been [adequately] established. Specifically,***
Quality [audits][reaudits] have not been performed. Specifically, ***

Process validation [activities] [results] have not been [documented] [approved] [adequately
documented] [adequately approved]. Specifically, ***
Acceptance activities were not [documented] [maintained as part of the device history record]
[adequately documented] [adequately maintained as part of the device history record]. Specifically, ***
Records of complaint investigations do not include required information. Specifically, ***

Document control procedures have not been [established] [maintained]. Specifically,***
Procedures for design verification have not been [adequately] established. Specifically,***
The design history file [was not established] [does not demonstrate that the design was developed
following the approved design plan] [does not demonstrate that the design was developed following the
requirements of 21 CFR 820].
Products that do not conform to specifications are not adequately controlled. Specifically, ***
Quality audits were not performed [at defined intervals] [at sufficient frequency] to determine whether
the quality system activities and results comply with quality system procedures. Specifically, ***
Individuals who conduct quality audits have direct responsibility for the matters being audited.
Specifically, ***
Management with executive responsibility has not reviewed the suitability and effectiveness of the
quality system [at defined intervals] [with sufficient frequency]. Specifically, ***
Procedures for changes to a [specification] [method] [process] [procedure] have not been [adequately]
established. Specifically, ***
The organizational structure has not been [adequately] established and maintained to ensure that
devices are [designed] [produced] in accordance with 21 CFR 820. Specifically, ***
Production processes were not [developed] [conducted] [controlled] [monitored] to ensure that a device
conforms to its specifications. Specifically, ***
The type and extent of control to be exercised over [the product] [services] [suppliers] [contractors]
[consultants] was not clearly defined. Specifically, ***
Procedures for design review have not been [adequately] established. Specifically,***
Software used as part of [production] [the quality system] has not been [adequately] validated for its
intended use according to an established protocol. Specifically, ***
Personnel training is not documented. Specifically, ***
Requirements that must be met by [suppliers] [contractors] [consultants] have not been [adequately]
An MDR report was not submitted within 30 days of receiving or otherwise becoming aware of
information that reasonably suggests that a marketed device may have caused or contributed to a death
or serious injury. Specifically, ***
An investigation was not conducted according to the [signed agreement] [investigational plan] [applicable
FDA regulations]. Specifically, ***
An investigation was not conducted in accordance with [the signed agreement] [the investigational plan]
[applicable FDA regulations] [conditions of approval imposed by an IRB] [conditions of approval imposed
by FDA]. Specifically, ***
Procedures for the [acceptance] [control] of in-process product have not been [adequately] established.
Specifically, ***
Procedures to control labeling activities have not been [adequately] established. Specifically, ***
The evaluation of potential [suppliers] [contractors] [consultants] was not documented. Specifically, ***
Design verification does not confirm that design output meets design input requirements. Specifically,
***
Records of acceptable [suppliers] [contractors] [consultants] have not been [adequately] established.
Procedures or instructions for [performing servicing activities] [verifying that servicing meets specified
requirements] have not been [adequately] established. Specifically, ***
A correction or removal, conducted to reduce a risk to health posed by a device, was not reported in
writing to FDA. Specifically, ***
Quality system procedures and instructions have not been established. Specifically,***
Procedures for rework of nonconforming product have not been [adequately] established. Specifically,
***
The written MDR Procedure does not include an internal system which provides for the timely and
effective [identification] [communication] [evaluation] of events that may be subject to medical device
reporting requirements. Specifically, ***
Design plans that describe or reference the design and development activities and define responsibility
for implementation have not been [adequately] established. Specifically, ***
Design input requirements were not [adequately] documented. Specifically, ***
Procedures that define the responsibility for review and the authority for the disposition of
nonconforming product have not been [adequately] established. Specifically, ***
Procedures for the control of storage areas and stock rooms have not been [adequately] established.
Specifically,***
Procedures for design transfer have not been [adequately] established. Specifically,***
Not all complaints have been [adequately] reviewed and evaluated to determine whether an investigation
is necessary. Specifically, ***
Sampling plans are not [written][based on valid statistical rationale]. Specifically, ***
Documents that were [not approved] [obsolete] were observed at a location where they [could be] [are
being] used. Specifically, ***
Records of each subject's [case history] [exposure to the investigational device] are not all [accurate]
[complete] [current]. Specifically, ***
Procedures for monitoring and control of process parameters for a validated process have not been
[adequately] established. Specifically, ***
Schedules for the adjustment, cleaning, and other maintenance of equipment have not been
[adequately] established. Specifically, ***
Acceptance or rejection of incoming product was not documented. Specifically, ***
The written MDR procedure does not include an internal system which provides for a standardized review
process/procedure for determining when an event meets the criteria for reporting. Specifically, ***
Procedures to prevent contamination of equipment or product by substances that may have an adverse
effect on product quality have not been [adequately] established. Specifically, ***
There is no agreement with [suppliers] [contractors] [consultants] to notify you of changes in the product
or service. Specifically, ***
Personnel do not have the necessary [education] [background] [training] [experience] to perform their
jobs. Specifically, ***
Procedures for identifying valid statistical techniques required for establishing, controlling, and verifying
the acceptability of process capability and product characteristics have not been [adequately]
established. Specifically,***
The acceptance status of product was not [identified to indicate conformance or nonconformance with
acceptance criteria] [maintained]. Specifically, ***
A validated process was not [reviewed and evaluated] [revalidated] when changes or process deviations
occurred. Specifically, ***
The results of design validation, including [identification of the design] [method(s)] [the date] [the
individual(s) performing validation], were not [adequately] documented in the design history file.
Specifically, ***
Procedures for design input have not been [adequately] established. Specifically,***
The design verification results, including [identification of the design] [method(s)] [the date] [the
individual(s) performing the verification], were not [adequately] documented in the design history file.
Specifically, ***
Documents were [not reviewed] [not approved] by designated individual(s) prior to issuance .
Specifically, ***
Records documenting that informed consent was obtained for each subject prior to participation in the
study are not all [accurate] [complete] [current]. Specifically, ***
Labels and labeling used for each finished product, lot, or batch, were not sufficiently documented in the
DHR. Specifically, ***
Potential [suppliers] [contractors] [consultants] were not [evaluated] [selected] based on their ability to
meet specified requirements. Specifically, ***
There is [no] [inadequate] documentation of [monitoring and control methods and data] [the date
performed] [the individual performing the process] [the major equipment used] for a validated process.
Specifically, ***
Complaint handling procedures for [receiving] [reviewing] [evaluating] complaints have not been
[established] [defined] [documented] [completed] [implemented]. Specifically, ***
Procedures for control and distribution of finished devices have not been [adequately] established.
Specifically,***
A quality plan has not been [adequately] established. Specifically, ***
Records for complaints where no investigation was made do not include required information.
Specifically ***
The design was not validated [under defined operating conditions] [using initial production units, lots or
batches or their equivalents]. Specifically, ***
Design validation did not ensure the device conforms to defined user needs and intended uses.
Specifically, ***
The documentation of approval of documents does not include [the document approval date] [the
signature of the approving official]. Specifically, ***
Records of changes did not include [a description of the change] [identification of the affected
documents] [the signature of the approving official(s)] [the approval date] [when the change became
effective]. Specifically, ***
Software validation activities and results for computers or automated data processing systems used as
part of [production] [the quality system] have not been [adequately] documented. Specifically, ***
Equipment [calibrations] [inspections] [checks][maintenance activities] have not been documented.

Specifically, ***
In-process inspections, tests, or other verification activities and approvals were not documented.
Specifically, ***
The [appropriate design, construction, placement, and installation of manufacturing equipment have not
been ensured] [equipment used in the manufacturing process does not meet specified requirements].
Specifically, ***
Procedures for design output have not been [adequately] established. Specifically,***
A supplemental report was not submitted to FDA within one month following receipt of information that
was not provided when the initial report was submitted. Specifically, ***
The [quality policy] [quality objectives] [was] [were] not established by management with executive
responsibility. Specifically, ***
The design review results, including [identification of the design] [the date] [the individual(s) performing
the review], were not documented in the design history file. Specifically, ***
Records of [receipt] [use] [disposal] of a device that relate to the [type and quantity] [dates of receipt]
[batch number or code mark] of the device are not all [accurate] [complete] [current]. Specifically, ***
Procedures to ensure sampling methods are adequate for their intended use have not been [adequately]
The results and/or dates of management reviews are not documented. Specifically, ***
A justification for not reporting the correction or removal action to FDA that included [conclusions]
[follow-ups] [reviews] by a designated person was not included in the record. Specifically,***
Procedures for identifying product during all stages of receipt, production, distribution, and installation
have not been [adequately] established. Specifically, ***
The written MDR procedure does not include an internal system which provides for timely transmission
of complete medical device reports to [FDA] [manufacturers]. Specifically, ***
Informed consent was not obtained in accordance with the regulations regarding the protection of
human subjects. Specifically, ***
Complaints representing events that are MDR reportable were not [promptly reviewed, evaluated, and
investigated by a designated individual] [maintained in a separate portion of the complaint files] [clearly
identified]. Specifically, ***
Records of changes to documents were not [adequately] maintained. Specifically, ***
Purchasing data that clearly describe or reference specified requirements for purchased or otherwise
received product and services have not been [approved] [established] [adequately approved] [adequately
established]. Specifically, ***
Certain [inspection] [measuring] [test] equipment is not [suitable for its intended purposes] [capable of
producing valid results]. Specifically, ***
Validation of device software [was not performed] [is inadequate] [is incomplete]. Specifically, ***
Rework and reevaluation activities have not been [fully] documented in the device history record.
Specifically, ***
Records for each subject concerning [anticipated] [unanticipated] adverse device effects are not all
[accurate] [complete] [current]. Specifically, ***
Results of the design risk analysis were not [adequately] documented. Specifically, ***
The device design was not correctly translated into production specifications. Specifically, ***
The written MDR procedure does not include documentation and recordkeeping requirements for all
Medical Device Reports and information submitted to [FDA] [device manufacturers]. Specifically, ***
Procedures for product handling have not been [adequately] established. Specifically,***
Required records [are not maintained at a location that is reasonably accessible to responsible officials of
the manufacturer and to employees of the FDA] [were not made readily available for review and copying
by the FDA] [are not legible] [are not stored to minimize deterioration and prevent loss] [are not backed
up when stored in automated data processing systems]. Specifically, ***
Acceptance criteria were not established prior to the performance of validation activities. Specifically,
***
When test/measurement equipment was found to not meet accuracy and precision limits, [no]
[inadequate] action was taken to [bring the equipment into calibration] [evaluate whether there was any
adverse effect on the device's quality]. Specifically, ***
The DHR does not include [complete] records of examination and release of device labeling, including
date and signature of the examiner. Specifically, ***
Service reports [are not documented] [do not include the required information]. Specifically, ***
Management with executive responsibility has not ensured that the quality policy is understood,
implemented and maintained at all levels of the organization. Specifically, ***
The written MDR procedure does not include documentation and recordkeeping requirements for all
information that was evaluated to determine if an event was reportable. Specifically, ***
Device packaging and/or shipping containers are not designed and constructed to protect the device
from alteration or damage during processing, storage, handling, and distribution. Specifically, ***
[Installation instructions] [inspection instructions] [test procedures] have not been [adequately]
Calibration procedures do not include [specific directions and limits for accuracy and precision]
[provisions for remedial action]. Specifically, ***
Results of the validation of the device software were not [adequately] documented. Specifically, ***
An MDR report submitted to FDA did not include all information that was reasonably known to the
manufacturer. Specifically, ***
Service reports were not analyzed following appropriate statistical methods. Specifically, ***
There is no documentation of the [review and evaluation of a process] [revalidation of a process]
performed in response to changes or process deviations. Specifically, ***
Design output was not [adequately] documented before release. Specifically, ***
Documentation of rework and reevaluation activities does not include a determination of whether there
has been any adverse effect from rework upon the product. Specifically, ***
Design plans were not [reviewed] [updated] [approved] as design and development evolves. Specifically,
***
Procedures for verifying that design output meets design input were not [established] [defined]
[documented] [complete] [implemented]. Specifically, ***
Records for each subject concerning [previous medical history] [condition upon entering the
investigation] [condition during the course of the investigation] [all diagnostic test results] are not all
Signed investigator agreements that include the required financial disclosure information are not all
Copies maintained of the study protocol are not all [accurate] [complete] [current]. Specifically, ***
Requirements have not been [adequately] established to address personnel [health] [cleanliness]
[personal practices] [clothing]. Specifically, ***
The device master record does not include or refer to the location of device software specifications.
Specifically, ***
Evaluations of out-of-calibration equipment and remedial actions taken were not documented.
Specifically, ***
Labeling was not sufficiently examined by a designated individual for accuracy including [the correct
expiration date] [control numbers] [storage instructions] [handling instructions] [certain additional
processing instructions] before release. Specifically, ***
Investigation records of MDR reportable complaints do not include required information. Specifically ***
A violation of the FD&C Act involving a device which might present a risk to health was not reported to
FDA. Specifically, ***
Periodic inspections of equipment [were not] conducted to ensure adherence to applicable maintenance
schedules [were not documented]. Specifically, ***
The dates of quality [audits][reaudits] have not been documented. Specifically, ***
Procedures were not [established] [defined] [documented] [complete] [implemented] for ensuring that
participants at each design review include [representatives of all functions concerned with the design
stage being reviewed] [an individual who does not have direct responsibility for the design stage being
reviewed] [any specialists needed]. Specifically, ***
An investigational device was [promoted] [test marketed] prior to FDA approval/clearance. Specifically,
***
For an investigational study, [qualified investigators were not selected] [investigators were not provided
with the information they need to conduct an investigation properly] [proper monitoring was not
ensured] [IRB review and approval were not ensured] [an IDE application was not submitted to FDA for a
significant risk study] [reviewing IRBs were not promptly informed of significant new information about
an investigation] [FDA was not promptly informed of significant new information about an investigation].
Specifically, ***
Records relating to correspondence with [another investigator] [an IRB] [the sponsor] [a monitor] [FDA],
including required reports, are not all [accurate] [complete] [current]. Specifically, ***
Required records were not all maintained [during the investigation] [for a period of two years after the
date on which an investigation was terminated or completed] [for a period of two years after the date
that the records were no longer required for purposes of supporting a premarket approval application or
a notice of completion of a product development protocol]. Specifically, ***
Buildings [are not of suitable design] [do not contain sufficient space] to [perform necessary operations]
[prevent mix-ups] [assure orderly handling of product]. Specifically, ***
Equipment used in the manufacturing process has not been appropriately [designed] [constructed]
[placed] [installed] to facilitate maintenance, adjustment, cleaning, and use. Specifically, ***
Procedures for the use and removal of manufacturing material have not been [adequately] established.
Specifically, ***
The quality system record has not been [adequately] maintained Specifically ***
Required records are not retained for [the design and expected life of the device] [at least 2 years from
the date of release of the device for commercial distribution]. Specifically, ***
The device history record does not include the primary identification label and labeling for each device.
Specifically, ***
A clinical investigation that was determined to be a non-significant risk device study does not meet the
abbreviated requirements for investigational device exemptions (IDEs). Specifically, ***
A signed investigator agreement was not obtained from each participating investigator . Specifically,***
Process control procedures that describe any process controls necessary to ensure conformance to
specifications were not [established] [defined] [documented] [implemented]. Specifically, ***
Reports of results of quality [audits] [reaudits] are not reviewed by management having responsibility for
the matters audited. Specifically, ***
Design output was not [reviewed] [approved] before release. Specifically, ***
The rights, safety, and welfare of subjects in an investigational study were not [adequately] protected.
Specifically, ***
Subjects were allowed to participate in an investigation prior to obtaining [IRB] [FDA] approval to conduct
the investigation. Specifically, ***
Records that relate to the [reason why devices] [quantity of devices that] were [returned to the sponsor]
[repaired] [disposed of] are not all [accurate] [complete] [current]. Specifically, ***
Records of disposition of a device which describe the batch number or code marks of any devices
[returned to the sponsor] [repaired] [disposed of by the investigator or another person] and the reasons
for and method of disposition reports are not all [accurate] [complete] [current]. Specifically, ***
In a non-emergency situation, [changes to] [deviations from] the investigational plan that could have
affected [the scientific soundness of the plan] [the rights, safety, or welfare of human subjects] were
initiated without prior approval of the changes from [the sponsor] [FDA] [the IRB] . Specifically, ***
For an investigation subject to the abbreviated requirements, progress reports were not [always]
submitted to all reviewing IRBs [at required intervals] [at least annually]. Specifically, ***
Progress reports for a significant risk device study were not submitted [at required intervals] [at least
yearly] to [FDA] [all reviewing IRBs]. Specifically, ***
Records that FDA requires by [regulation] [specific requirement] to be maintained for [a category of
investigations] [a particular investigation] are not all [accurate] [complete] [current]. Specifically, ***
The design was not validated under actual or simulated use conditions. Specifically, ***
Changes to documents were not [reviewed and approved by an individual(s) in the same function or
organization that performed the original review and approval] [communicated to appropriate personnel
in a timely manner]. Specifically, ***
Documents were not available at all locations for which they are designated, used, or otherwise
necessary. Specifically, ***
The procedures addressing documentation of corrective and preventive action activities were not
[established] [defined] [documented] [complete] [implemented]. Specifically, ***
The person installing the device did not [adequately] document the inspection and test results to
demonstrate proper installation.
Records of complaint investigations are not maintained by the formally designated unit. Specifically, ***
Design input requirements were not [reviewed] [approved] by designated individual(s). Specifically, ***
Corrective and preventive actions have not been verified or validated to ensure that the action is effective
and does not adversely affect the finished device. Specifically, ***
For an investigation subject to the abbreviated requirements, a final report was not submitted to all
reviewing IRBs [within six months] after [termination] [completion] of an investigational device study.
Specifically, **
An MDR adverse event report was submitted on a form other than FDA Form 3500A (MEDWATCH form)
or an approved electronic equivalent. Specifically, ***
The written MDR procedure does not include documentation and recordkeeping requirements for
systems that ensure access to information that facilitates timely follow-up and inspection by FDA.
Specifically, ***
MDR event files have not been established and maintained. Specifically, ***
MDR event files do not contain or reference all adverse event information in the possession of the
reporting entity, including documentation of the deliberations and decision making process used to
determine if an event was or was not reportable. Specifically, ***
A submitted MDR event was not evaluated in accordance with the requirements of the regulations
regarding [Failure Investigations] [Complaint Files]. Specifically, ***
MDR files do not contain explanations of why required information [was not submitted] [could not be
obtained]. Specifically, ***
The user facility did not submit FDA Form 3500A or electronic equivalent to the [known device
manufacturer] [FDA, because the device manufacturer was unknown,] within 10 working days of
becoming aware of information that reasonably suggests that a device has or may have caused or
contributed to a serious injury to a patient of the facility. Specifically, ***
An MDR report with incomplete information was submitted to FDA without a statement explaining why
such information was incomplete and the steps taken to obtain the information. Specifically, ***
An individual medical device manufacturer report submitted per FDA Form 3500A did not indicate in
Block B that the outcome attributed to the adverse event was death. Specifically, ***
A 5 day report was not submitted to FDA on Form 3500A within 5 workdays of becoming aware that a
reportable MDR event necessitates remedial action to prevent an unreasonable risk of substantial harm
to the public health. Specifically, ***
An investigational device was commercialized by charging the [subjects] [investigators] a price larger than
that necessary to recover costs of manufacture, research, development, and handling. Specifically, ***
An application was not submitted to FDA when [a significant risk device investigation was to be
undertaken] [an investigation that involves exception from informed consent was intended] [FDA sent
notification that an application was required for an investigation]. Specifically, ***
[An investigation] [Part of an investigation] was initiated before [FDA approval] [IRB approval]. Specifically,
***
The signed investigator agreements obtained from each participating investigator do not all include the
investigator's curriculum vitae. Specifically, ***
A signed agreement that includes a statement of the investigator's commitment to conduct an

investigation in accordance with the [agreement] [investigational plan] [applicable FDA regulations]
[conditions of approval imposed by the reviewing IRB] [conditions of approval imposed by the FDA] was
not obtained from each participating investigator. Specifically, ***
The reviewing IRB did not notify [the investigator] [the sponsor] after determining that a device study,
presented for approval as a non-significant risk device study, was actually a significant risk device study.
Specifically, ***
Records relating to correspondence with [another sponsor] [a monitor] [an investigator] [an IRB] [FDA],
including required reports are not all [accurate] [complete] [current]. Specifically, ***
For an investigation subject to the abbreviated requirements, records are not [consolidated in one
location] [available for FDA inspection and copying]. Specifically, ***
For an investigation subject to the abbreviated requirements, records which include the [name and
intended use of the device] [objectives of the investigation] are not all [accurate] [complete] [current].
Specifically, ***
For an investigation subject to the abbreviated requirements, records that include the name and address
of each IRB that has reviewed the investigation are not all [accurate] [complete] [current]. Specifically,
***
For an investigation subject to the abbreviated requirements, records that include a statement of the
extent to which the regulations covering current good manufacturing practice would be followed in
manufacturing the device reports are not all [accurate] [complete] [current]. Specifically, ***
For an investigation subject to the abbreviated requirements, records that include additional information
required by FDA are not all [accurate] [complete] [current]. Specifically, ***
Records that FDA requires to be maintained for [a category of investigation] [a particular investigation]
are not all [accurate] [complete] [current]. Specifically, ***
A complete and accurate report of an unanticipated adverse device effect was not prepared and
submitted [within 10 working days after first learning of the effect] to [the sponsor] [the reviewing IRB].
Specifically, ***
Progress reports on the investigation were not submitted [at the required intervals] [at least yearly] to the
[sponsor] [monitor] [reviewing IRB]. Specifically, ***
Prior approval was not obtained from the sponsor for [changes in] [deviations from] an investigational
plan in a non-emergency situation. Specifically, ***
A final report to the [sponsor] [reviewing IRB] was not submitted [within three months] after
[termination] [completion] of the investigation. Specifically, ***
Reports of the results of evaluation of unanticipated adverse device effects were not all submitted [within
10 working days of receiving notice of the effect] to [FDA] [all reviewing IRBs] [all participating
investigators]. Specifically, ***
Notification was not sent to [FDA] [all reviewing IRBs] of a request that an investigator [return] [repair]
[dispose of] any units of a device. Specifically, ***
FDA was not notified [within 30 working days] of the [completion] [termination] of a significant risk
device study. Specifically, ***
The device master record does not include or refer to the location of [all] production and process
specifications. Specifically, ***
Complete complaint files are not maintained. Specifically, ***
The purchasing data were not approved. Specifically, ***
Control numbers for [implantable or life supporting devices] [appropriate components] were not
documented in the device history record. Specifically, ***
Procedures for addressing the [identification] [documentation] [evaluation] [segregation] [disposition]

[investigation] of nonconforming product were not [defined] [documented] [complete]. Specifically, ***
Service reports that represent MDR reportable events were not automatically considered complaints and
processed in accordance with the requirements of 21 CFR 820.198. Specifically, ***
Investigated complaints and records of investigation were not accessible to the manufacturing
establishment. Specifically, ***
Complaint handling procedures have not been [established] [defined] [documented] [completed]
[implemented] to ensure that all complaints are evaluated to determine whether the complaint should
be filed as a Medical Device Report. Specifically, ***
Records of complaint investigations do not include the [name] [address] [phone number] of the
complainant. Specifically, ***
The manufacturer's formally designated complaint unit is located outside of the United States and
complaint records are not reasonably accessible in the United States. Specifically, ***
Service reports do not include applicable test and/or inspection data. Specifically, ***
During production, [process parameters] [component and device characteristics] are not [fully]
monitored and controlled. Specifically, ***
Requirements addressing the [health] [cleanliness] [personal practices] [clothing] of employees have not
been implemented. Specifically, ***
Not all [data] [reports] from quality data sources are analyzed to identify existing and potential causes of
nonconforming product and other quality problems. Specifically, ***
Illnesses or injuries that have occurred with use of devices subject to corrections or removals have not
been reported. Specifically,***
The [total number] [sub-lot identification] of devices subject to correction or removal actions was not
reported. Specifically,***
The [names] [addresses] [telephone numbers] of all domestic and foreign consignees of devices subject
to correction or removal actions and number of devices distributed to each consignee were not reported.
Specifically,***
No amended notification with required information was submitted within 10 working days of initiating an
extension of the correction or removal action. Specifically,***
There is no record maintained of a correction or removal action that was not required to be reported to
FDA. Specifically,***
The records of devices subject to correction and removal actions did not contain the [model] [catalog]
[code number] of the device and the manufacturing [lot] [serial number] [identifying number] of the
device. Specifically,***
Devices identified in an FDA tracking order were not tracked in accordance with tracking procedures.
Specifically, ***
A quality assurance program that includes audit procedures for each device subject to tracking and audits
performed at 6-month intervals for the first 3 years of distribution and annual audits thereafter using a
statistically relevant sampling [has not been established] [is not complete] [has not been followed].
Specifically,***
All device tracking records and all tracking information were not available for inspection. Specifically,***
Device complaint records are not [established] [maintained] by the device distributor, including any
relevant [incident information] [information regarding the evaluation of the allegations]. Specifically, ***
The importer failed to submit a report to FDA on FDA form 3500A, with a copy to the manufacturer,
within 30 days after receiving information that one of its marketed devices may have caused or
contributed to a [death] [serious injury]. Specifically, ***
A signed agreement was not obtained from each participating investigator that includes [sufficient
accurate financial disclosure information to allow the sponsor to submit a complete and accurate
certification or disclosure statement] [a commitment to promptly update financial disclosure information
if any relevant changes occur during the investigation and for one year following completion of the
study]. Specifically, ***
Devices under investigation were not properly controlled. Specifically, ***
Records showing [dates] [reasons for] each deviation from the protocol are not all [accurate] [complete]
[current]. Specifically,***
An investigation requires an IDE, in that the device is a diagnostic device which [is invasive] [requires an
invasive sampling procedure that presents significant risk] [by design or intention introduces energy into a
subject] [is used as a diagnostic procedure without confirmation of the diagnosis by another, medically
established diagnostic product or procedure]. Specifically, ***
A treatment IDE did not have FDA approval. Specifically, ***

A treatment use study of an investigational device did not [comply with the regulations governing
informed consent] [have IRB approval]. Specifically, ***
Frequency
378
245
133
127
124
110
98
93
77
73
72
70
69
61
61
58
58
57
55
54
53
52
51
51
46
45
43
41
41
39
38
38
37
37
37
36
36
35
35
32
30
30
29
28
28
28
26
26
26
26
25
24
24
24
23
22
22
21
21
20
20
20
20
20
19
18
18
17
16
15
15
15
14
14
14
14
13
13
13
13
13
12
11
11
11
11
11
11
11
10
10
10
10
10
10
10
10
10
10
10
8
8
6
6
3
3
2
2
1
1
1
1
1
1
1
1
1
1
1
Drugs 1105 21 CFR 211.22(d)
Drugs 2027 21 CFR 211.192
Drugs 1361 21 CFR 211.100(a)
Drugs 3603 21 CFR 211.160(b)
Drugs 1215 21 CFR 211.67(b)
Drugs 1451 21 CFR 211.113(b)
Drugs 1213 21 CFR 211.67(a)
Drugs 1883 21 CFR 211.165(a)
Drugs 3585 21 CFR 211.110(a)
Drugs 1914 21 CFR 211.166(a)
Drugs 1358 21 CFR 211.100(b)
Drugs 1274 21 CFR 211.68(a)
Drugs 2009 21 CFR 211.188
Drugs 4314 21 CFR 211.84(d)(2)

Drugs 1177 21 CFR 211.63
Drugs 1112 21 CFR 211.25(a)
Drugs 2419 21 CFR 211.198(a)
Drugs 1452 21 CFR 211.113(b)
Drugs 1890 21 CFR 211.165(e)
Drugs 1111 21 CFR 211.25(a)
Drugs 1133 21 CFR 211.25(a)
Drugs 1809 21 CFR 211.160(a)
Drugs 1943 21 CFR 211.180(e)(1)
Drugs 4402 21 CFR 211.192
Drugs 1159 21 CFR 211.28(a)
Drugs 1434 21 CFR 211.42(c)(10)(iv)
Drugs 1810 21 CFR 211.160(a)
Drugs 1767 21 CFR 211.137(a)
Drugs 2026 21 CFR 211.192
Drugs 4389 21 CFR 211.198(a)

Drugs 1891 21 CFR 211.165(f)
Drugs 1885 21 CFR 211.165(b)
Drugs 2028 21 CFR 211.192
Drugs 2031 21 CFR 211.194(a)
Drugs 3632 21 CFR 211.170(b)
Drugs 4303 21 CFR 211.67 b)
Drugs 4342 21 CFR 211.142(b)
Drugs 4352 21 CFR 211.160(b)(4)
Drugs 9001 21 CFR 211.22(a)
Drugs 1450 21 CFR 211.113(a)
Drugs 1787 21 CFR 211.80(a)
Drugs 3572 21 CFR 211.100(b)
Drugs 1448 21 CFR 211.111
Drugs 4391 21 CFR 211.180(e)(2)
Drugs 4576 21 CFR 211.192
Drugs 1920 21 CFR 211.166a)(3)
Drugs 1435 21 CFR 211.42(c)(10)(v)

Drugs 1833 21 CFR 211.84(d)(1)
Drugs 3559 21 CFR 211.56(a)
Drugs 1926 21 CFR 211.166(b)
Drugs 1975 21 CFR 211.182
Drugs 3547 21 CFR 211.46(b)
Drugs 3565 21 CFR 211.58
Drugs 1033 21 CFR 211.22(a)
Drugs 1263 21 CFR 211.68(b)
Drugs 1912 21 CFR 211.166(a)
Drugs 3571 21 CFR 211.100(a)
Drugs 3602 21 CFR 211.160(a)
Drugs 4413 21 CFR 211.194(a)(8)
Drugs 1098 21 CFR 211.22(c)
Drugs 1550 21 CFR 211.125(f)
Drugs 6732 21 CFR 314.80(c)(1)(i)
Drugs 1194 21 CFR 211.42(c)
Drugs 1932 21 CFR 211.167(a)
Drugs 2008 21 CFR 211.186(a)
Drugs 2619 21 CFR 211.198(b)(2)
Drugs 3561 21 CFR 211.56(b)

Drugs 8907 21 CFR 314.81(b)(1)(ii)
Drugs 1162 21 CFR 211.28(a)
Drugs 1540 21 CFR 211.125(a)
Drugs 4340 21 CFR 211.142
Drugs 4372 21 CFR 211.188(b)(8)
Drugs 1261 21 CFR 211.68(a)
Drugs 2205 21 CFR 211.186(b)(9)
Drugs 3616 21 CFR 211.165(d)
Drugs 3629 21 CFR 211.170(b)
Drugs 4401 21 CFR 211.186(b)(9)
Drugs 17764 21 CFR 212.20(e)
Drugs 1086 21 CFR 211.22(b)
Drugs 1227 21 CFR 211.67(c)
Drugs 1433 21 CFR 211.42(c)(10)(iii)
Drugs 1942 21 CFR 211.180(e)
Drugs 2007 21 CFR 211.186(a)
Drugs 4336 21 CFR 211.150
Drugs 4357 21 CFR 211.166(a)

Drugs 6730 21 CFR 314.80(b)
Drugs 8911 21 CFR 314.81(b)(1)(ii)
Drugs 17812 21 CFR 212.50
Drugs 1169 21 CFR 211.42(a)
Drugs 1395 21 CFR 211.103
Drugs 1802 21 CFR 211.84(b)
Drugs 3570 21 CFR 211.100(a)
Drugs 3583 21 CFR 211.110(a)
Drugs 1626 21 CFR 211.130
Drugs 1049 21 CFR 211.22(a)
Drugs 1270 21 CFR 211.68(b)
Drugs 1505 21 CFR 211.122(d)
Drugs 1790 21 CFR 211.80(b)
Drugs 1801 21 CFR 211.84(a)
Drugs 4317 21 CFR 211.84(d)(3)
Drugs 4406 21 CFR 211.194(a)(2)
Drugs 1134 21 CFR 211.25(b)

Drugs 1136 21 CFR 211.25(c)
Drugs 4338 21 CFR 211.150(b)
Drugs 1421 21 CFR 211.42(c)(10)
Drugs 1454 21 CFR 211.115(a)
Drugs 1869 21 CFR 211.94(c)
Drugs 3591 21 CFR 211.110(b)
Drugs 3613 21 CFR 211.160(b)(4)
Drugs 4306 21 CFR 211.80(a)
Drugs 4315 21 CFR 211.84(d)(2)
Drugs 17763 21 CFR 212.20(d)
Drugs 1163 21 CFR 211.28(b)
Drugs 1844 21 CFR 211.84(d)(2)
Drugs 1879 21 CFR 211.180(c)
Drugs 2012 21 CFR 211.188(b)
Drugs 4320 21 CFR 211.84(d)(6)
Drugs 4324 21 CFR 211.110(b)
Drugs 4351 21 CFR 211.160(b)(3)
Drugs 4359 21 CFR 211.170(a)(1), (b)(1)

Drugs 4377 21 CFR 211.188(b(3)
Drugs 6823 21 CFR 314.80(c)
Drugs 17749 21 CFR 212.30(a)
Drugs 1266 21 CFR 211.42(d)
Drugs 1495 21 CFR 211.122(a)
Drugs 1632 21 CFR 211.130(c)
Drugs 1728 21 CFR 211.87
Drugs 1803 21 CFR 211.84(b)
Drugs 1886 21 CFR 211.165(c)
Drugs 1918 21 CFR 211.166(a)(2)
Drugs 1976 21 CFR 211.182
Drugs 2044 21 CFR 211.196
Drugs 3557 21 CFR 211.52
Drugs 4302 21 CFR 211.56(b)
Drugs 4350 21 CFR 211.160(b)(3)
Drugs 4353 21 CFR 211.160(b)(4)
Drugs 4368 21 CFR 211.188(b)(12)
Drugs 4378 21 CFR 211.188(b)(2)
Drugs 4382 21 CFR 211.198(b)(2)

Drugs 4418 21 CFR 211.42(b)
Drugs 6736 21 CFR 314.80(c)(1)(ii)
Drugs 6831 21 CFR 314.80(c)(2)
Drugs 17722 21 CFR 212.10
Drugs 1388 21 CFR 211.101(d)
Drugs 1393 21 CFR 211.103
Drugs 1504 21 CFR 211.122(d)
Drugs 1545 21 CFR 211.125(c)
Drugs 1633 21 CFR 211.130(d)
Drugs 1636 21 CFR 211.130(e)
Drugs 1774 21 CFR 211.142(a)
Drugs 1777 21 CFR 211.150(b)
Drugs 1842 21 CFR 211.84(d)(1)
Drugs 1843 21 CFR 211.84(d)(2)
Drugs 1868 21 CFR 211.94(b)
Drugs 1876 21 CFR 211.180(a), (b)
Drugs 1917 21 CFR 211.166(a)(1)
Drugs 1922 21 CFR 211.166(a)(4)

Drugs 1928 21 CFR 211.166(c)(1)
Drugs 2003 21 CFR 211.184(c)
Drugs 2033 21 CFR 211.194(c)
Drugs 2034 21 CFR 211.194(d)
Drugs 2567 21 CFR 211.198(a)
Drugs 2569 21 CFR 211.198(b)
Drugs 3445 21 CFR 211.65(a)
Drugs 3594 21 CFR 211.110(d)
Drugs 4373 21 CFR 211.188(b)(7)
Drugs 4388 21 CFR 211.198(a)
Drugs 4399 21 CFR 211.186(b)(7)
Drugs 4410 21 CFR 211.194(a)(5)
Drugs 6728 21 CFR 314.80(b)
Drugs 17741 21 CFR 212.30(b)
Drugs 17742 21 CFR 212.30(b)

Drugs 17851 21 CFR 212.60(c)
Drugs 1174 21 CFR 211.42(b)
Drugs 1722 21 CFR 211.134(a)
Drugs 1725 21 CFR 211.134(c)
Drugs 1798 21 CFR 211.82(b)
Drugs 1851 21 CFR 211.84(e)
Drugs 1927 21 CFR 211.166(b)
Drugs 1933 21 CFR 211.167(a)
Drugs 2035 21 CFR 211.194(e)
Drugs 3553 21 CFR 211.48(a)
Drugs 3562 21 CFR 211.56(c)
Drugs 3569 21 CFR 211.89
Drugs 3582 21 CFR 211.105(a)
Drugs 3611 21 CFR 211.160(b)(3)
Drugs 3614 21 CFR 211.160(b)(4)
Drugs 3623 21 CFR 211.170(a)
Drugs 3639 21 CFR 211.204
Drugs 4305 21 CFR 211.68(b)

Drugs 4328 21 CFR 211.122(a)
Drugs 4330 21 CFR 211.130(e)
Drugs 4343 21 CFR 211.160(b)(1)
Drugs 4344 21 CFR 211.160(b)(1)
Drugs 4356 21 CFR 211.166(b)
Drugs 4369 21 CFR 211.188(b)(11)
Drugs 4371 21 CFR 211.188(b)(9)
Drugs 4400 21 CFR 211.186(b)(8)
Drugs 4404 21 CFR 211.194(a)(1)
Drugs 4409 21 CFR 211.194(a)(4)
Drugs 6832 21 CFR 314.80(c)(2)
Drugs 6842 21 CFR 314.80(i)
Drugs 8912 21 CFR 314.81(b)(2)
Drugs 17850 21 CFR 212.60(b)

Drugs 17932 21 CFR 212.60(b)
Drugs 17940 21 CFR 212.71(a)
Drugs 1079 21 CFR 211.22(a)
Drugs 1218 21 CFR 211.67(b)(1)
Drugs 1413 21 CFR 211.42(c)(5)
Drugs 1430 21 CFR 211.42(c)(10)(i)
Drugs 1449 21 CFR 211.111
Drugs 1456 21 CFR 211.115(b)
Drugs 1496 21 CFR 211.122(a)
Drugs 1629 21 CFR 211.130(a)
Drugs 1630 21 CFR 211.130(b)
Drugs 1637 21 CFR 211.130(e)
Drugs 1724 21 CFR 211.134(b)
Drugs 1791 21 CFR 211.80(c)
Drugs 1797 21 CFR 211.82(a)
Drugs 1846 21 CFR 211.84(d)(3)
Drugs 1958 21 CFR 211.180(f)
Drugs 1978 21 CFR 211.182

Drugs 2014 21 CFR 211.188(b)(2)
Drugs 2196 21 CFR 211.186(b)(1)
Drugs 2401 21 CFR 211.194(a)(4)
Drugs 3548 21 CFR 211.46(c)
Drugs 3550 21 CFR 211.46(c)
Drugs 3551 21 CFR 211.46(d)
Drugs 3573 21 CFR 211.101(b)
Drugs 3581 21 CFR 211.101(d)
Drugs 3588 21 CFR 211.110(a)(3)
Drugs 3592 21 CFR 211.110(c)
Drugs 3610 21 CFR 211.160(b)(3)
Drugs 3631 21 CFR 211.170(b)
Drugs 4304 21 CFR 211.68(b)
Drugs 4307 21 CFR 211.80(d)
Drugs 4345 21 CFR 211.160(b)(1)
Drugs 4355 21 CFR 211.165(c)
Drugs 4360 21 CFR 211.170(b)
Drugs 4366 21 CFR 211.188(a)
Drugs 4374 21 CFR 211.188(b)(6)

Drugs 4383 21 CFR 211.198(b)(1)
Drugs 4386 21 CFR 211.198(b)
Drugs 4403 21 CFR 211.194(b)
Drugs 4405 21 CFR 211.194(a)(2)
Drugs 4415 21 CFR 211.204
Drugs 4416 21 CFR 211.204
Drugs 6735 21 CFR 314.80(c)(1)(ii)
Drugs 6830 21 CFR 314.80(c)(2)
Drugs 6833 21 CFR 314.80(c)(2)(ii)
Drugs 8935 FDCA 760(b)(1)
Drugs 17743 21 CFR 212.30(b)
Drugs 17745 21 CFR 212.30(b)
Drugs 17755 21 CFR 212.20(a)

Drugs 17769 21 CFR 212.40(a)
Drugs 17772 21 CFR 212.40(b)
Drugs 17813 21 CFR 212.50(a)
Drugs 17842 21 CFR 212.50(d)
Drugs 17849 21 CFR 212.60(a)
Drugs 17858 21 CFR 212.60(f)
Drugs 17859 21 CFR 212.60(g)
Drugs 17883 21 CFR 212.70(d)(3)
Drugs 1167 21 CFR 211.34
Drugs 1168 21 CFR 211.34
Drugs 1219 21 CFR 211.67(b)(2)
Drugs 1220 21 CFR 211.67(b)(3)
Drugs 1222 21 CFR 211.67(b)(4)
Drugs 1224 21 CFR 211.67(b)(6)
Drugs 1251 21 CFR 211.42(c)(1)
Drugs 1256 21 CFR 211.68(b)

Drugs 1371 21 CFR 211.101(a)
Drugs 1384 21 CFR 211.101(c)
Drugs 1396 21 CFR 211.42(c)(2)
Drugs 1411 21 CFR 211.105(b)
Drugs 1418 21 CFR 211.42(c)(7)
Drugs 1431 21 CFR 211.42(c)(10)(ii)
Drugs 1436 21 CFR 211.42(c)(10)(vi)
Drugs 1509 21 CFR 211.122(h)
Drugs 1726 21 CFR 211.86
Drugs 1794 21 CFR 211.80(d)
Drugs 1796 21 CFR 211.80(d)
Drugs 1818 21 CFR 211.84(c)(2)
Drugs 1824 21 CFR 211.84(c)(5)
Drugs 1845 21 CFR 211.84(d)(3)
Drugs 1849 21 CFR 211.84(d)(6)
Drugs 1852 21 CFR 211.94(a)

Drugs 1870 21 CFR 211.94(d)
Drugs 1938 21 CFR 211.167(c)
Drugs 1941 21 CFR 211.180(d)
Drugs 1957 21 CFR 211.180(e)(2)
Drugs 1999 21 CFR 211.184(a)
Drugs 2020 21 CFR 211.188(b)(8)
Drugs 2023 21 CFR 211.188(b)(11)
Drugs 2200 21 CFR 211.186(b)(4)
Drugs 2201 21 CFR 211.186(b)(5)
Drugs 2402 21 CFR 211.194(a)(5)
Drugs 2406 21 CFR 211.194(a)(8)
Drugs 2420 21 CFR 211.198(a)
Drugs 2572 21 CFR 211.198(b)
Drugs 2621 21 CFR 211.198(b)(3)
Drugs 3554 21 CFR 211.48(a)
Drugs 3558 21 CFR 211.52
Drugs 3567 21 CFR 211.84(d)(2)

Drugs 3597 21 CFR 211.122(g)(3)
Drugs 3630 21 CFR 211.170(b)
Drugs 4310 21 CFR 211.84(c)(3)
Drugs 4313 21 CFR 211.84(c)(6)
Drugs 4316 21 CFR 211.84(d)(3)
Drugs 4322 21 CFR 211.101(d)
Drugs 4325 21 CFR 211.110(a)
Drugs 4349 21 CFR 211.160(b)(2)
Drugs 4354 21 CFR 211.165(d)
Drugs 4370 21 CFR 211.188(b)(10)
Drugs 4375 21 CFR 211.188(b)(5)
Drugs 4376 21 CFR 211.188(b)(4)
Drugs 4379 21 CFR 211.188(b)(1)
Drugs 4387 21 CFR 211.198(a)
Drugs 4390 21 CFR 211.180c)
Drugs 4411 21 CFR 211.194(a)(6)

Drugs 4412 21 CFR 211.194(a)(7)
Drugs 4414 21 CFR 211.204
Drugs 6825 21 CFR 314.80(c)(1)(iii)
Drugs 6827 21 CFR 314.80(c)(1)(iv)
Drugs 6829 21 CFR 314.80(c)(2)
Drugs 6835 21 CFR 314.80(d)(1)
Drugs 6838 21 CFR 314.80(e)(1)
Drugs 8914 21 CFR 314.81(b)(2)(iv)(b)
Drugs 8922 21 CFR 314.81(b)(2)(viii)
Drugs 17002 FDCA 501(a)
Drugs 17744 21 CFR 212.30(b)
Drugs 17753 21 CFR 212.30(c)
Drugs 17757 21 CFR 212.20(b)
Drugs 17761 21 CFR 212.20(c)
Drugs 17765 21 CFR 212.20(d)
Drugs 17770 21 CFR 212.40(a)
Drugs 17821 21 CFR 212.50(b)(6)

Drugs 17822 21 CFR 212.50(b)(7)
Drugs 17823 21 CFR 212.50(b)(8)
Drugs 17832 21 CFR 212.50(c)(4)
Drugs 17846 21 CFR 212.50(f)(2)
Drugs 17853 21 CFR 212.60(d)
Drugs 17855 21 CFR 212.60(e)
Drugs 17865 21 CFR 212.60(g)(5)
Drugs 17869 21 CFR 212.61(a)
Drugs 17870 21 CFR 212.61(b)
Drugs 17872 21 CFR 212.70(a)
Drugs 17874 21 CFR 212.70(b)
Drugs 17877 21 CFR 212.70(c)
Drugs 17886 21 CFR 212.70(e)
Drugs 17896 21 CFR 212.71(a)
Drugs 17897 21 CFR 212.71(b)
Drugs 17898 21 CFR 212.71(c)
Drugs 17904 21 CFR 212.80(d)
Drugs 17913 21 CFR 212.100(a)
Drugs 17927 21 CFR 212.110(b)

Drugs 17937 21 CFR 212.70(e)
Drugs 17939 21 CFR 212.71(a)
Drugs 17941 21 CFR 212.71(b)

Short Description
Procedures not in writing, fully followed
Investigations of discrepancies, failures
Absence of Written Procedures
Scientifically sound laboratory controls
Written procedures not established/followed
Procedures for sterile drug products
Cleaning / Sanitizing / Maintenance
Testing and release for distribution
Control procedures to monitor and validate

performance
Lack of written stability program
SOPs not followed / documented
Calibration/Inspection/Checking not done
Prepared for each batch, include complete information
Reports of Analysis (Components)

Equipment Design, Size and Location
Training--operations, GMPs, written procedures
Complaint Handling Procedure
Validation lacking for sterile drug products
Test methods
Training , Education , Experience overall
GMP Training Frequency
Following/documenting laboratory controls
Review of representative number of batches
Written record of investigation incomplete
Clothing appropriate for duties performed
Environmental Monitoring System
Lab controls established, including changes
Expiration date lacking
Quality control unit review of records
Procedures to be written and followed

Failing drug products not rejected
Microbiological testing
Extent of discrepancy, failure investigations
Complete test data included in records
Annual visual exams of drug products
Written procedures fail to include
Storage under appropriate conditions
Calibration - at intervals, written program, remedial

action
Lack of quality control unit
Procedures for non-sterile drug products
Procedures To Be in Writing
Procedure Deviations Recorded and Justified
Establishment of time limitations
Items to cover on annual reviews
No written record of investigation
Valid stability test methods
Cleaning System
Identity Testing of Each Component
Sanitation--buildings not clean, free of infestation
Adequate number of batches on stability
Written records kept in individual logs
Equipment for Environmental Control
Buildings not maintained in good state of repair
Authority lacking to review records, investigate errors
Computer control of master formula records
Written program not followed
Changes to Procedures Not Reviewed, Approved
Deviations from laboratory control requirements
Second person sign off
Approve or reject procedures or specs
Procedures Written and Followed
Late submission of 15-day report
Defined areas of adequate size for operations
Sterility/pyrogen-free testing
Written procedures followed
Complaint Investigation/Follow-Up Findings
Written sanitation procedures lacking

Contamination, chemical or physical change,
deterioration
Protective Apparel Not Worn
Strict control not exercised over labeling issued
Written warehousing procedures established/followed
Labeling control records including specimens or copies
Written calibration / inspection records not kept
Manufacturing Instructions and Specifications
Acceptance criteria for sampling & testing
Reserve samples identified, representative, stored
Complete instructions, procedures, specifications et. al.
Written QA procedures established, followed
Adequate lab facilities not available
Cleaning/maintenance records not kept
Air Supply
Records reviewed annually
Signature and checking of records -- 2 persons
Written distribution procedure
Results not used for expiration dates, storage cond.

Failure to develop written procedures
Failure to meet specifications
Adequate controls (general)
Buildings of Suitable Size, Construction, Location
Actual vs. theoretical yields not determined
Representative Samples
Approval and review of procedures
Written in-process control procedures
Procedures are written, and followed
Approve or reject components, products
input/output verification
Label storage access limited to authorized personnel
Handling and Storage to Prevent Contamination
Components withheld from use pending release
Certificates of Testing (Containers, Closures)
Suitability of testing methods verified
Supervisor Training/Education/Experience
Inadequate number of personnel
Recall facilitation
Aseptic Processing Area
Reprocessing procedures not written or followed
Containers & Closures Clean, Sterilized, Pyrogen-free
In-process materials specifications
Establishment of calibration procedures
Written Procedures Not Followed
Testing Each Component for Conformity with Specs
Determination need for investigation
Habits of good sanitation & health
Establish reliability of supplier's C of A
Records not made readily available to FDA
Batch production and Batch Control Record

Requirements
Microbiological Contamination Exam
In-process materials specifications testing
Drug products - samples representative, identified

properly
Retention time of reserve samples, in general

Identification of each component or in-process
material
Failure by applicant to report ADE
Penicillin processing area not kept separate
Written procedures describing in detail
Lot or control number assigned
Retest of approved components/containers/closures
Representative Samples Criteria
Sampling and testing plans not described
Stability sample storage conditions described
Specific information required in individual logs
Distribution Record Requirements
Washing and toilet facilities are deficient
Written sanitation procedures not followed
Drug products-sampling procedures/specifications
Instruments, apparatus, et. al. not meeting specs
Investigations made into any unexplained discrepancy
Identity of major equipment and lines used
Written record of complaint to include findings, follow-

up
Adequate space lacking to prevent mix-ups and
contamination
Submission of report follow-up
Late submission of quarterly safety reports
Lack Adequate Resources, Facilities, Equipment.
Component addition checked by 2nd person
Yield calculations not verified by 2nd person
Labels and labeling stored separately
Label reconciliation discrepancies

evaluation/investigation
Examination of packaging and labeling
Packaging line inspection before use
Quarantine - actual practice
Distribution Recall System
Component identity verification
Component written specification
Protection from external factors
Record maintenance 1 year (except exempt OTC)
Sample size - test intervals
Testing in same container - closure system

Homeopathic drugs, assessment of stability
Individual inventory record
Testing and standardization of standards et. al.
Laboratory equipment calibration records
Adverse Drug Experience
Maintenance of Complaint File
Equipment construction - reactive surfaces
Rejected in-process materials not quarantined
Actual yield, % of theoretical yield
Complaints reviewed by Quality Control Unit
Theoretical yield statement including percentages
Calculations performed are in the records
Failure to review ADE information
Equipment not clean
Equipment not suitable

Analytical methods
Product flow through building is inadequate
Correct labels during finishing operations
Examinations documented
Quarantine Storage of Components
Rejecting When Specifications Not Met
Accelerated stability studies
Sterility/pyrogens - test methods written, followed
Stability testing records not included
Plumbing System Defects
Written procedures lacking for use of pesticides etc.
Quarantine of Rejected Components et. al.
Identification of containers, lines, equipment
Acceptance of drug products
Written calibration procedures
Active ingredient retained sample kept
Returned drug procedures in writing and followed
Backup data not assured as exact and complete

Written procedures not followed
Packaging line inspection documentation
Incoming lots - conformance to written specs-
Sampling and testing procedures described
Tentative expiration date
Identification of persons involved, each significant step
Description of containers and closures
Description of containers, labels, et. al.
Sample identification and other information
Data secured in course of each test
Late submission of annual safety reports
Failure to maintain records
Timely submission
Lab sampling and test procedures

Testing Procedures- Conformance to Standards
Non-Conforming Product Investigation Incomplete
Contract drug products--lack of responsibility
Cleaning SOP/responsibility
Mfg / Processing Operations Area
Floors, walls, ceiling surfaces
Deviations of production time limits
Reprocessing/quality control unit
Sampling/testing of labeling/packaging materials
Prevention of cross contamination, mix-ups
Unlabeled filled containers controls
Packaging line inspection after use
Representative samples after completion
Storage off Floor, Spaced Suitably
Examination on receipt, before acceptance
Establish reliability of supplier's C of A
Responsible firm officials notified in writing
Personnel dating/signing equipment log

Identification of Equipment and Lines
Product Name and Strength
Complete Test Data
Air filtration system lacking in production area

Exhaust systems inadequate to control air
contamination
Penicillin air handling systems not kept separate
Measured components for manufacturing
Verification of component addition
Mixing adequacy
In-process materials characteristics testing
Drug product sample
Investigation of reserve sample deterioration
Written record not kept of program and validation data
Status of Each Lot Identified
Samples (various types) representative, identified

properly
Sampling and testing plans not followed
Reserve drug product sample quantity - all tests
Accurate reproduction included
Inspection of packaging and labeling area

Written complaint record must include
Written complaint record to be maintained at facility
Test method modification records do not include
Statement of methods and data
Returned drug products with doubt cast as to safety et.

al.
Reprocessed returned drug products
Failure to investigate serious, unexpected events
Interval
Incomplete periodic safety report
Failure of responsible person to report AE (non-RX

Drug)
Equipment procedures overall
Equipment not properly maintained
Oversight of production operations

Content of written procedures
Written specs - components
Written control procedures
Records of checks made
Testing procedures
Documenting procedures
Test records complete (general)
Final dated signature
Qualifications lacking
Consultant Records
Cleaning SOPs/schedules
Cleaning SOPs/instructions
Cleaning SOPs/equipment identification
Cleaning SOP/inspection
Incoming material area
Backup file not maintained

Batches Formulated to less than 100%
Weighing/measuring/subdividing operations
Rejected Material Area
Distinctive ID or code not recorded in batch record
Quarantined Drug Products Area
Temperature / Humidity Controls
Equipment to control conditions
Printing devices
Rotation of components/containers/closures
Disposition recorded by lot identification
Identification of Each Lot in Each Shipment
Appropriate Opening of Component Containers
Identifying Sample Containers
Container/Closure Written Test Procedure
Objectionable microbiological contamination
Reactive/Additive/Absorptive Containers/Closures
Written Procedures to Remove Pyrogens
Controlled release dosage form testing
Reader/Photocopy equipment not made available
Review of problem drugs
Record information required
Labeling Control Records and Label Copies
Identification of Persons Performing Significant Steps
Variation in the Amount of Components Used
Calculated Excess of Components Used
Testing Calculations
Identification of Person Performing Review of Lab

Records
Quality Control Review
Complaint File Location
Reason for Not Conducting Complaint Investigation
Potable water standards not met
Washing and toilet facilities not provided and accessible
Component identification test

Visual inspection
Drug product reserve containers
Sterile Equipment, Aseptic Techniques in sample

collecting
Containers Marked to Show Samples Taken
Testing Containers & Closures Conformity with Specs
Component release checked by 2nd person
Control procedures fail to include the following
In-process samples representative, identified properly
Acceptance/Rejection Levels
Records of any sampling performed
In-process and laboratory control results
Weights and measures of components used
Dates not included for each significant step
Reporting of adverse drug experience to FDA
Photocopying of records not allowed
Test results, comparison with standards not included

Signatures and dates--person who performs test
Record information maintained
Non-applicant reports to applicant
Failure to identify report content
Failure to report non-alert ADEs
Failure to submit scientific article
Failure to report post-marketing study ADEs
Mfg and control changes not requiring a supplemental

app.
Post marketing study status report for other studies
Drug Field Exam
Equipment not properly installed
Contact surfaces
Examine, approve or reject
Proposed changes to existing specs/methods
Review of records for errors
Suitable for intended use
Action limits on radiochemical yield

Complete instructions, procedures, specs
Container & label descriptions
Each major production step
Documentation of activities
Supplies adequately controlled
Equipment
Initials, signature, date
Samples representative, stored properly
Use of stability test results
Specifications
Before implementing new procedure establish accuracy

etc.
Conform to specs prior to release
When 30 hour rule is exceeded
Rejection of nonconforming product
Investigation of nonconforming product
Correction of problems
Labeling and product mix-ups
Written complaint procedures
Record quality
Notification to Facilities Re: Received PET Drug Sterility
Procedures to Investigate Cause of Non-Conforming

Product
Documentation of Non-Conforming Product
Investigation
Long Description
The responsibilities and procedures applicable to the quality control unit are not [in writing] [fully
followed]. Specifically, ***
There is a failure to thoroughly review [any unexplained discrepancy] [the failure of a batch or any of its
components to meet any of its specifications] whether or not the batch has been already distributed.
Specifically, ***
There are no written procedures for production and process controls designed to assure that the drug
products have the identity, strength, quality, and purity they purport or are represented to possess.
Specifically, ***
Laboratory controls do not include the establishment of scientifically sound and appropriate
[specifications] [standards] [sampling plans] [test procedures] designed to assure that [components]
[drug product containers] [closures] [in-process materials] [labeling] [drug products] conform to
appropriate standards of identity, strength, quality and purity. Specifically, ***
Written procedures are not [established] [followed] for the cleaning and maintenance of equipment,
including utensils, used in the manufacture, processing, packing or holding of a drug product.
Specifically, ***
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile
are not [established] [written] [followed]. Specifically, ***
Equipment and utensils are not [cleaned] [maintained] [sanitized] at appropriate intervals to prevent
[malfunctions] [contamination] that would alter the safety, identity, strength, quality or purity of the drug
product. Specifically, ***
Testing and release of drug product for distribution do not include appropriate laboratory determination
of satisfactory conformance to the [final specifications] [identity and strength of each active ingredient]
prior to release. Specifically, ***
Control procedures are not established which [monitor the output] [validate the performance] of those
manufacturing processes that may be responsible for causing variability in the characteristics of in-
process material and the drug product. Specifically, ***
There is no written testing program designed to assess the stability characteristics of drug products.
Specifically, ***
Written production and process control procedures are not [followed in the execution of production and
process control functions] [documented at the time of performance]. Specifically, ***
Routine [calibration] [inspection] [checking] of [automatic] [mechanical] [electronic] equipment is not

performed according to a written program designed to assure proper performance. Specifically, ***
Batch production and control records [are not prepared for each batch of drug product produced] [do not
include complete information relating to the production and control of each batch]. Specifically, ***
Reports of analysis from component suppliers are accepted in lieu of testing each component for
conformity with all appropriate written specifications, without [performing at least one specific identity
test on each component] [establishing the reliability of the supplier's analyses through appropriate
validation of the supplier's test results at appropriate intervals]. Specifically, ***
Equipment used in the manufacture, processing, packing or holding of drug products is not [of
appropriate design] [of adequate size] [suitably located] to facilitate operations for its [intended use]
[cleaning and maintenance]. Specifically, ***
Employees are not given training in [the particular operations they perform as part of their function]
[current good manufacturing practices] [written procedures required by current good manufacturing
practice regulations]. Specifically, ***
Procedures describing the handling of written and oral complaints related to drug products are [not
written or followed] [deficiently written or followed]. Specifically, ***
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile

do not include [adequate] validation of the sterilization process. Specifically, ***
The [accuracy] [sensitivity] [specificity] [reproducibility] of test methods have not been [established]
[documented]. Specifically, ***
Employees engaged in the [manufacture] [processing] [packing] [holding] of a drug product lack the
[education] [training] [experience] required to perform their assigned functions. Specifically, ***
GMP training is not conducted [on a continuing basis] [with sufficient frequency] to assure that
employees remain familiar with CGMP requirements applicable to them. Specifically, ***
Established [specifications] [standards] [sampling plans] [test procedures] [laboratory control

mechanisms] are not [followed] [documented at the time of performance]. Specifically, ***
Written procedures are not [established] [followed] for evaluations conducted at least annually to review
records associated with a representative number of batches, whether approved or rejected. Specifically,
***
Written records of investigations into [unexplained discrepancies] [the failure of a batch or any of its
components to meet specifications] do not [always] include the conclusions and follow-up. Specifically,
***
Clothing of personnel engaged in the [manufacturing] [processing] [packing] [holding] of drug products is
not appropriate for the duties they perform. Specifically, ***
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
Specifically, ***
The establishment of [specifications] [standards] [sampling plans] [test procedures] [laboratory control
mechanisms] including any changes thereto, are not [drafted by the appropriate organizational unit]
[reviewed and approved by the quality control unit]. Specifically, ***
Drug products do not bear an expiration date determined by appropriate stability data to assure they
meet applicable standards of identity, strength, quality and purity at the time of use. Specifically, ***
Drug product production and control records, are not [reviewed] [approved] by the quality control unit to
determine compliance with all established, approved written procedures before a batch is released or
distributed. Specifically, ***
Procedures describing the handling of all written and oral complaints regarding a drug product are not
[established] [written] [followed]. Specifically, ***
Drug products failing to meet established [standards] [specifications] [quality control criteria] are not
rejected. Specifically, ***
Each batch of drug product required to be free of objectionable microorganisms is not tested through
appropriate laboratory testing. Specifically, ***
Investigations of [an unexplained discrepancy] [a failure of a batch or any of its components to meet any
of its specifications] did not extend to [other batches of the same drug product] [other drug products
that may have been associated with the specific failure or discrepancy]. Specifically, ***
Laboratory records do not include complete data derived from all tests, examinations and assay necessary
to assure compliance with established specifications and standards. Specifically, , ***
Reserve samples from representative sample lots or batches of drug products selected by acceptable
statistical procedures are not examined visually at least once a year for evidence of deterioration.
Specifically, ***
Written procedures for cleaning and maintenance fail to include [assignment of responsibility]
[maintenance and cleaning schedules] [description in sufficient detail of methods, equipment and
materials used] [description in sufficient detail of the methods of disassembling and reassembling
equipment as necessary to assure proper cleaning and maintenance] [instructions for removal or
obliteration of previous batch identification] [instructions for protection of clean equipment from
contamination prior to use] [parameters relevant to the operation]. Specifically, ***
Drug products are not stored under appropriate conditions of [temperature] [humidity] [light] so that
their identity, strength, quality, and purity are not affected. Specifically, ***
The calibration of [instruments] [apparatus] [gauges] [recording devices] is not done at suitable intervals
[in accordance with an established written program] [with provisions for remedial action in the event
accuracy and/or precision limits are not met]. Specifically, ***
There is no quality control unit. Specifically, ***
Procedures designed to prevent objectionable microorganisms in drug products not required to be sterile
are not [established] [written] [followed]. Specifically, ***
Written procedures are lacking which describe in sufficient detail the [receipt] [identification] [storage]
[handling] [sampling] [testing] [approval] [rejection] of [components] [drug product containers]
[closures]. Specifically, ***
Deviations from written production and process control procedures are not [recorded] [justified].
Specifically, ***
Time limits are not established when appropriate for the completion of each production phase to assure
the quality of the drug product. Specifically, ***
Written procedures are not [established] [followed] for evaluations done at least annually and including
provisions for a review of [complaints] [recalls] [returned or salvaged drug products] [investigations
conducted for each drug product]. Specifically, ***
Written records are not [always] made of investigations into [unexplained discrepancies] [the failure of a
batch or any of its components to meet specifications]. Specifically, ***
The written stability program for drug products does not include [reliable] [meaningful] [specific] test
methods. Specifically, ***
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the [room]
[equipment] to produce aseptic conditions. Specifically, ***
The identity of each component of a drug product is not verified by conducting at least one test to verify
the identity, using specific identity tests if they exist. Specifically, ***
Buildings used in the manufacture, processing, packing or holding of drug products are not [maintained in
a clean and sanitary condition] [free of infestation by rodents, birds insects, and other vermin].
Specifically, ***
An adequate number of batches of each drug product are not tested [nor are records of such data
maintained] to determine an appropriate expiration date. Specifically, ***
Written records of major equipment [cleaning] [maintenance] [use] are not included in individual
equipment logs. Specifically, ***
Equipment for adequate control over [air pressure] [micro-organisms] [dust] [humidity] [temperature] is
not provided when appropriate for the manufacture, processing, packing or holding of a drug product.
Specifically, ***
Buildings used in the [manufacturing] [processing] [packing] [holding] of a drug product are not
maintained in a good state of repair. Specifically, ***
The quality control unit lacks authority to [review production records to assure that no errors have
occurred] [fully investigate errors that have occurred]. Specifically, ***
Appropriate controls are not exercised over computers or related systems to assure that changes in
master production and control records or other records are instituted only by authorized personnel.
Specifically, ***
The written stability testing program is not followed. Specifically, ***
Changes to written procedures are not [drafted, reviewed and approved by the appropriate
organizational unit] [reviewed and approved by the quality control unit]. Specifically, ***
Deviations from written [specifications] [standards] [sampling plans] [test procedures] [laboratory
mechanisms] are not [recorded] [justified]. Specifically, ***
Laboratory records do not include the initials or signature of a second person showing that the original
records have been reviewed for [accuracy] [completeness] [compliance with established standards].
Specifically, ***
The quality control unit lacks responsibility to [approve] [reject] all procedures or specifications impacting
on the [identity] [strength] [quality] [purity] of drug products. Specifically, ***
Procedures describing in sufficient detail the controls employed for the issuance of labeling are not
[written] [followed]. Specifically, ***
Not all adverse drug experiences that are both serious and unexpected have been reported to FDA within
15 calendar days of initial receipt of the information. Specifically, ***
The [separate or defined areas][control systems] necessary to prevent contamination or mix-ups are
deficient. Specifically, ***
Each batch of drug product purporting to be [sterile] [pyrogen-free] is not laboratory tested to determine
conformance to such requirements. Specifically, ***
Procedures for the preparation of master production and control records are not [described in a written
procedure] [followed]. Specifically, ***
Complaint records are deficient in that they do not include the findings of the [investigation] [follow-up].
Specifically, ***
There is a lack of written procedures [assigning responsibility] [providing cleaning schedules] [describing
in sufficient detail the methods, equipment and materials to be used] for sanitation. Specifically, ***
An NDA-Field Alert Report was not submitted within three working days of receipt of information
concerning [bacteriological contamination] [significant chemical, physical, or other change or
deterioration] in a distributed drug product. Specifically, ***
Protective apparel is not worn as necessary to protect drug products from contamination. Specifically,
***
Strict control is not exercised over labeling issued for use in drug product labeling operations. Specifically,
***
Procedures describing the warehousing of drug products are not [established] [followed]. Specifically,
***
Batch production and control records do not include complete labeling control records, including
specimens or copies of all labeling used for each batch of drug product produced. Specifically, ***
Records of the [calibration checks] [inspections] of automatic, mechanical or electronic equipment,

including computers or related systems are not maintained. Specifically, ***
The master production and control records are deficient in that they do not include complete
[manufacturing] [control] [instructions] [sampling] [testing] [procedures] [specifications] [special
notations] [precautions]. Specifically, ***
Acceptance criteria for the sampling and testing conducted by the quality control unit is not adequate to
assure that batches of drug products meet [each appropriate specification] [appropriate statistical quality
control criteria] as a condition for their approval and release. Specifically, ***
Reserve drug product samples are not [appropriately identified] [representative of each lot or batch of
drug product] [retained and stored under conditions consistent with product labeling]. Specifically, ***
Master production and control records lack [complete manufacturing and control instructions] [sampling
and testing procedures] [specifications] [special notations] [precautions to be followed]. Specifically, ***
You did not [establish] [follow] written quality assurance procedures. Specifically,***
Adequate lab facilities for testing and approval or rejection of [components] [drug product containers]
[closures] [packaging materials] [in-process materials] [drug products] are not available to the quality
control unit. Specifically, ***
Records are not kept for the [maintenance] [cleaning] [sanitizing] [inspection] of equipment. Specifically,
***
Aseptic processing areas are deficient regarding air supply that is filtered through high-efficiency
particulate air filters under positive pressure. Specifically, ***
Records are not maintained so that data therein can be reviewed at least annually to evaluate the quality
standards of each drug product to determine the need for changes in specifications or manufacturing or
control procedures. Specifically, ***
The master production and control records for each batch size of drug product are not [prepared, dated,
and signed by one person with a full handwritten signature] [independently checked, dated, and signed
by a second person]. Specifically, ***
Written distribution procedures are not [established] [followed]. Specifically, ***
Results of stability testing are not used in determining [appropriate storage conditions] [expiration dates].
Specifically, ***
Written procedures have not been developed for the [surveillance] [receipt] [evaluation] [reporting to
FDA] of post marketing adverse drug experiences. Specifically, ***
An NDA-Field Alert Report was not submitted within three working days of receipt of information
concerning a failure of one or more distributed batches of a drug to meet the specifications established
for it in the application. Specifically, ***
Your firm lacks adequate production and process controls to ensure the consistent production of a PET
drug that meets the applicable standards of identity, strength, quality and purity. Specifically,***
Buildings used in the manufacture, processing, packing, or holding of a drug product do not have the
suitable [size] [construction] [location] to facilitate cleaning, maintenance, and proper operations.
Specifically, ***
Actual yield and percentages of theoretical yield are not determined at the conclusion of each
appropriate phase of [manufacturing] [processing] [packaging] [holding] of the drug product. Specifically,
***
Representative samples are not taken of each shipment of each lot of [components] [drug product
containers] [closures] for testing or examination. Specifically, ***
Written procedures are not [drafted, reviewed and approved by the appropriate organizational units]
[reviewed and approved by the quality control unit]. Specifically, ***
Written procedures are not [established] [followed] that describe the [in-process controls] [tests]
[examinations] to be conducted on appropriate samples of in-process materials of each batch.
Specifically, ***
Procedures designed to assure that correct [labels] [labeling] [packaging materials] are used for drug
products are not [written] [followed]. Specifically, ***
The quality control unit lacks the responsibility and authority to [approve] [reject] all [components] [drug
product containers] [closures] [in process materials] [packaging material] [labeling] [drug products].
Specifically, ***
Input to and output from [the computer] [related systems of formulas] [records or data] are not checked
for accuracy. Specifically, ***
Access to the storage area for labels and labeling materials is not limited to authorized personnel.
Specifically, ***
There was a failure to handle and store [components] [drug product containers] [closures] at all times in a
manner to prevent contamination. Specifically, ***
Each lot of [components] [drug product containers] [closures] is not withheld from use until the lot has
been sampled, tested, examined, and released by the quality control unit. Specifically, ***
Certificates of testing of [containers] [closures] are accepted in lieu of testing without [a visual
identification] [establishing the reliability of the supplier's test results through appropriate validation of
the test results at appropriate intervals]. Specifically, ***
The suitability of all testing methods is not verified under actual conditions of use. Specifically, ***
Individuals responsible for supervising the [manufacture] [processing] [packing] [holding] of a drug
product lack the [education] [training] [experience] to perform their assigned functions in such a manner
as to assure the drug product has the safety, identity, strength, quality and purity that it purports or is
represented to possess. Specifically, ***
The number of qualified personnel is inadequate to [perform] [supervise] the [manufacture] [processing]
[packing] [holding] of each drug product. Specifically, ***
A system by which the distribution of each lot of drug product can be readily determined to facilitate its
recall if necessary, has not been established. Specifically, ***
Separate or defined areas to prevent contamination or mix-ups are deficient regarding operations related
to aseptic processing of drug products. Specifically,***
Procedures prescribing a system for reprocessing batches to insure that the reprocessed batches will
conform with all established standards, specifications, and characteristics are not [written] [followed].
Specifically, ***
Drug product [containers] [closures] were not [clean] [sterilized and processed to remove pyrogenic
properties] to assure that they are suitable for their intended use. Specifically, ***
In-process specifications are not [consistent with drug product final specifications] [derived from previous
acceptable process average and process variability estimates where possible] [determined by the
application of suitable statistical procedures where appropriate]. Specifically, ***
Procedures describing the calibration of instruments, apparatus, gauges and recording devices are [not
written or followed] [deficiently written or followed]. Specifically, ***
Written procedures are not followed for the [receipt] [identification] [storage] [handling] [sampling]
[testing] [approval] [rejection] of [components] [drug product containers] [closures]. Specifically, ***
Each component is not tested for conformity with all appropriate written specifications for purity,
strength, and quality. Specifically, ***
When errors occurred or a production batch failed to meet specifications, you did not [determine the
need for an investigation] [conduct an investigation] [take appropriate corrective actions] when
necessary. Specifically,***
Production personnel were not practicing good sanitation and health habits. Specifically, ***
Establishment of the reliability of the component supplier's report of analyses is deficient in that the test
results are not appropriately validated at appropriate intervals. Specifically, ***
Records associated with drug product [components] [containers] [closures] [labeling] [production]
[control] [distribution] and within the retention period for such records, were not made readily available
for authorized inspection. Specifically, ***
The batch production and control records are deficient in that they do not include documentation of the
accomplishment of each significant step in [manufacturing] [processing] [packing] [holding]. Specifically,
***
Each lot of a [component] [drug product container] [closure] that is liable to microbiological
contamination that is objectionable in view of its intended use is not subjected to microbiological tests
before use. Specifically, ***
Examination and testing of samples is not done to assure that in-process materials conform to
Samples taken of drug products for determination of conformance to written specifications are not
[representative] [properly identified]. Specifically, ***
Reserve samples for [active ingredients] [drug products] are not retained for one year after the expiration
date of the drug product.
Batch production and control records do not include the specific identification of each batch of
[component] [in-process material] used for each batch of drug product produced. Specifically, ***
Adverse drug experience information has not been reported to FDA. Specifically, ***
Your facilities are not adequate to ensure the prevention of contamination of [equipment] [product] by
[substances] [personnel] [environmental conditions] that could reasonably be expected to have an
adverse effect on product quality. Specifically,***
The operations relating to the [manufacture] [processing] [packing] of penicillin are not performed in
facilities separate from those used for other drug products for human use. Specifically, ***
There is a lack of written procedures describing in sufficient detail the [receipt] [identification] [storage]
[handling] [sampling] [examination] [testing] of labeling and packaging materials. Specifically, ***
The drug product is not identified with a lot or control number that permits the determination of the
history of the manufacture and control of the batch. Specifically, ***
Approved [components] [drug product containers] [closures] are not retested or reexamined as
appropriate for identity, strength, quality and purity after [storage for long periods] [exposure to
conditions that might have an adverse effect] with subsequent approval or rejection by the quality
control unit. Specifically, ***
The [number of containers to be sampled] [amount of material taken from each container] is not based
upon appropriate criteria. Specifically, ***
Sampling and testing plans for drug products are not described in written procedures which include the
[method of sampling] [number of units per batch to be tested]. Specifically, ***
The written stability program for drug products does not describe the storage conditions for samples
retained for testing. Specifically, ***
Individual equipment logs do not show [time] [date] [product] [lot number of each batch processed].
Specifically, ***
Distribution records do not contain the [name and strength of the drug product] [description of dosage
form] [name and address of consignee] [date and quantity shipped] [lot or control number of drug
product]. Specifically, ***
Washing and toilet facilities lack [hot and cold water] [soap or detergent] [air driers or single-service
towels] [cleanliness]. Specifically, ***
Written procedures for sanitation are not followed. Specifically, ***
Laboratory controls do not include a determination of conformance to [written descriptions of sampling
procedures] [appropriate specifications] for drug products. Specifically, ***
The use of [instruments] [apparatus] [gauges] [recording devices] not meeting established specifications
was observed. Specifically, ***
Batch production and control records do not include the results of any investigation made into any
unexplained discrepancy, whether or not the batch of drug product had already been distributed.
Specifically, ***
Batch production and control records do not include the identity of individual major [equipment] [lines]
used for each batch of drug product produced. Specifically, ***
Written records of investigation of a drug complaint do not include [the findings of the investigation] [the
follow-up]. Specifically, ***
The building lacks adequate space for the orderly placement of equipment and materials to prevent mix-
ups between [different components] [drug product containers] [closures] [labeling] [in-process materials]
[drug products] and to prevent contamination. Specifically, ***
Follow-up reports were not submitted [within 15 calendar days of receipt of new information] [as
requested by FDA] concerning post marketing 15-day reports. Specifically, ***
Not all quarterly periodic adverse drug experience reports have been submitted within 30 days of the
close of the quarter. Specifically, ***
You lack adequate [resources] [facilities] [equipment] to enable your personnel to perform their
functions. Specifically, ***
Each component is not added to a batch by one person and verified by a second person. Specifically, ***
Yield calculations are not performed by one person and independently verified by a second person.
Specifically, ***
Labels and other labeling materials are not stored separately with suitable identification for each different
drug product, strength, dosage form or quantity of contents. Specifically, ***
Discrepancies found outside preset limits when reconciling the quantities of labeling issued, used and
returned, were not [evaluated] [investigated]. Specifically, ***
Examination of packaging and labeling materials for suitability and correctness before packaging
operations is [not performed] [not documented in the batch production records]. Specifically, ***
Inspection of the [packaging] [labeling] facilities immediately before use is not done to assure that all
drug products have been removed from previous operations. Specifically, ***
Drug products are not quarantined before being released by the quality control unit. Specifically, ***
The distribution system is deficient in that each lot of drug product cannot be readily determined to
facilitate its recall if necessary. Specifically, ***
Drug product component testing is deficient in that at least one specific test to verify the identity of each
component is not performed. Specifically,***
Component testing is deficient in that each component is not tested for conformity with all appropriate
written specifications for purity, strength, and quality. Specifically, ***
Container closure systems do not provide adequate protection against foreseeable external factors in
storage and use that can cause deterioration or contamination of the drug product. Specifically, ***
All records of [production] [control] [distribution] [components] [drug product containers] [closures]
[labeling] associated with a batch of drug product are not maintained at least one (1) year after the
expiration date. Specifically, ***
The written stability program for drug products does not include [sample size] [test intervals] based on
statistical criteria for each attribute examined to assure valid estimates of stability. Specifically, ***
The written stability program does not assure testing of the drug product in the same container-closure
system as that in which the drug product is marketed. Specifically, ***
There is no written assessment of stability of homeopathic drug products based at least on [testing or
examination of the drug product for compatibility of the ingredients] [marketing experience with the
drug product to indicate that there is no degradation of the product for the normal or expected period of
use]. Specifically, ***
Records fail to include an individual inventory record of each [component] [reconciliation of the use of
each component] [drug product container] [drug product closure] with sufficient information to allow
determination of any associated batch or lot of drug product. Specifically, ***
Laboratory records do not include complete records of any testing and standardization of laboratory
[reference standards] [reagents] [standard solutions]. Specifically, ***
Laboratory records do not include complete records of the periodic calibration of laboratory
[instruments] [apparatus] [gauges] [recording devices]. Specifically, ***
Complaint procedures are deficient in that they do not include provisions that allow for the review to
determine if the complaints represent [serious] [unexpected adverse drug experiences] which are
required to be reported to FDA. Specifically, ***
Complaint procedures are deficient in that written complaint records are not maintained in a file
designated for drug product complaints. Specifically, ***
Equipment surfaces that contact [components] [in-process materials] [drug products] are reactive,
additive or absorptive so as to alter the safety, identity, strength, quality, or purity of the drug product
beyond the official or other established requirements. Specifically, ***
Rejected in-process materials are not [identified] [controlled under a quarantine system] to prevent their
use in manufacturing or processing operations for which they are unsuitable. Specifically, ***
The batch production and control records do not include a statement of the [actual yield] [percentage of
theoretical yield] at appropriate stages of processing for each batch of drug product produced.
Specifically, ***
Written procedures describing the handling of complaints do not include provisions for [review by the
quality control unit of any complaint involving the possible failure of a drug product to meet any of its
specifications] [a determination as to the need for an investigation of any unexplained discrepancy]
[explaining the reasons for the failure of the batch or any of its components to meet specifications].
Specifically, ***
Master production and control records lack a statement of theoretical yield [including the maximum and
minimum percentages of theoretical yield beyond which investigation is required]. Specifically, ***
Laboratory records do not include a record of all calculations performed in connection with the test.
Specifically, ***
Adverse drug experience information obtained or otherwise received from any source was not [promptly]
reviewed, including information from [commercial marketing experience] [post marketing clinical
investigations] [post marketing epidemiological/surveillance activities] [reports in the scientific literature]
[unpublished scientific papers]. Specifically, ***
You did not implement procedures to ensure that all your equipment is clean. Specifically, ***
You did not implement procedures to ensure that all your equipment is suitable for its intended purposes.
Specifically,***
Your laboratory analytical methods [are not suitable for their intended use] [are not sufficiently sensitive]
[are not sufficiently specific] [are not accurate] [are not reproducible]. Specifically,***
The flow of [components] [drug product containers] [closures] [labeling] [in-process materials ] [drug
products] though the building is not designed to prevent contamination. Specifically, ***
Packaged and labeled products are not examined during finishing operations to provide assurance that
containers and packages in the lot have the correct label. Specifically, ***
The results of the examination of the packaged and labeled products were not documented in the batch
production or control records. Specifically, ***
Incoming [components] [drug product containers] [closures] are not stored under quarantine until they
have been tested or examined, as appropriate, and released. Specifically, ***
Failure to reject any lot of [components] [drug product containers] [closures] that did not meet the
appropriate written specifications for identity, strength, quality, and purity. Specifically, ***
Accelerated stability studies, combined with basic stability information, used to support tentative
expiration dates are not supported with ongoing full shelf life studies. Specifically, ***
Test procedures relative to appropriate laboratory testing for [sterility] [pyrogens] are not [written]
[followed]. Specifically, ******
Laboratory records do not include complete records of all stability testing performed. Specifically, ***
The plumbing system contains defects that could contribute to the contamination of drug products.
Specifically, ***
Written procedures are lacking for the use of [rodenticides] [insecticides] [fungicides] [fumigating agents]
[cleaning and sanitizing agents] designed to prevent the contamination of [equipment] [components]
[drug product containers] [closures] [packaging, labeling materials] [drug products]. Specifically, ***
Rejected [components] [drug product containers] [closures] are not controlled under a quarantine system
designed to prevent their use in manufacturing or processing operations for which they are unsuitable.
Specifically, ***
All [compounding and storage containers] [processing lines] [major equipment] used during the
production of a batch of drug product is not properly identified at all times to indicate [contents] [the
phase of processing of the batch]. Specifically, ***
Determinations of conformance to appropriate written specifications for acceptance are [not made]
[deficient] for drug products. Specifically, ***
Written calibration procedures for instruments, apparatus, gauges, and recording devices are deficient in
that they do not include specific [directions] [schedules] [limits for accuracy and precision] [provisions for
remedial action if limits are not met]. Specifically, ***
A sample which is representative of each lot in each shipment of each active ingredient is not
[appropriately identified] [retained]. Specifically, ***
Procedures describing the [holding] [testing] [reprocessing] of returned drug products are not [in writing]
[followed]. Specifically, ***
Backup data is not assured as [exact] [complete] [secure from alteration, erasure or loss] through keeping
hard copy or alternate systems. Specifically, ***
Written procedures for the [receipt] [identification] [storage] [handling] [sampling] [examination] [testing]
of packaging and labeling materials are not followed. Specifically, ***
Results of inspection of packaging and labeling facilities are not documented in the batch production
records. Specifically, ***
Laboratory controls do not include determination of conformance to appropriate written specifications

for the acceptance of each lot within each shipment of [components] [drug product containers] [closures]
[in-process materials] [labeling] [drug products] used in the manufacture, processing, packing, or holding
of drug products. Specifically, ***
Written specifications for laboratory controls do not include a description of the [sampling] [testing]
procedures used. Specifically, ***
Where data from accelerated studies was used to project a tentative expiration date beyond a date
supported by actual shelf life studies, there were no [stability studies] [drug product testing at
appropriate intervals] conducted until the tentative expiration date was verified or the appropriate
expiration date determined. Specifically, ***
Batch production and control records do not include the identification of the persons [performing]
[directly supervising] [checking] each significant step in the operation, for each batch of drug product
produced. Specifically, ***
Batch production and control records do not include a description of drug product [containers] [closures]
used for each batch of drug product produced. Specifically, ***
Master production and control records lack [a description of the drug product containers, closures and
packaging materials] [a specimen or copy of each label and all other labeling] [the signatures and dates
entered by the person or persons responsible for the approval of labeling]. Specifically, ***
Laboratory records do not include [a description of the sample received for testing] [the source or
location from where the sample was obtained] [the quantity of the sample] [the lot number or other
distinctive code of the sample] [the date the sample was taken] [the date the sample was received for
testing]. Specifically, ***
Laboratory records do not include a complete record of all data secured in the course of each test,
including all [graphs] [charts] [spectra] from laboratory instrumentation, properly identified to show the
[specific component] [drug product container] [closure] [in-process material] [lot tested] [drug product
tested]. Specifically, ***
Not all annual periodic adverse drug experience reports have been submitted within 60 days of the
anniversary date of the approval of the application. Specifically, ***
Records relating to all adverse drug experiences known to you, including raw data and any
correspondence, have not been maintained for the required ten year period. Specifically, ***
An annual report was not submitted [each year] [within 60 days of the anniversary date of U.S. approval
of the application] to the FDA division responsible for reviewing the application. Specifically, ***
Each laboratory did not have sampling procedures which are designed to ensure that [components] [in-
process materials] [PET drug products] conform to appropriate standards including established standards
of identity, strength, quality and purity. Specifically,***
Each laboratory did not have testing procedures which are designed to ensure that [components] [in-
process materials] [PET drug products] conform to appropriate standards including established standards
of identity, strength, quality and purity. Specifically,***
The investigation of the cause of the nonconforming batch of a PET drug product did not include
examination of the [processes] [operations] [records] [complaints] [other relevant sources of information]
concerning the nonconforming product. Specifically***
The quality control unit lacks responsibility for approving or rejecting drug products [manufactured]
[processed] [packed] [held] under contract by another company. Specifically, ***
Procedures for the cleaning and maintenance of equipment are deficient regarding assignment of
responsibility for cleaning and maintaining equipment. Specifically, ***
Separate or defined areas to prevent contamination or mix-ups are deficient regarding the manufacturing
and processing operations. Specifically, ***
Aseptic processing areas are deficient in that [floors] [walls] [ceilings] are not smooth and/or hard
surfaces that are easily cleanable. Specifically,***
Deviations from production time limits [are not justified] [are not documented] [compromise the quality
of the drug product]. Specifically, ***
Reprocessing was performed without the [review] [approval] of the quality control unit. Specifically, ***
Labeling and packaging materials are not [representatively sampled] [examined] [tested] upon receipt
and before use in packaging and labeling of a drug product. Specifically, ***
There is insufficient physical or spatial separation from operations and other drug products to prevent
mix-ups and cross-contamination. Specifically, ***
Filled drug product containers which are set aside and held in an unlabeled condition are not [identified]
[handled] to preclude mislabeling of individual containers, lots or portions of lots. Specifically, ***
Inspection of the [packaging] [labeling] facilities is not done after use to assure that materials not suitable
for subsequent operations have been removed. Specifically, ***
Samples of representative units were not [collected] [visually examined] for correct labeling at the
completion of finishing operations. Specifically, ***
Bagged or boxed components of drug product [containers] [closures] are not [stored off the floor]
[suitably spaced to allow cleaning and inspection]. Specifically, ***
Each container or grouping of containers of [components] [drug product containers] [closures] is not
examined visually upon receipt and before acceptance for [appropriate labeling as to contents] [container
damage] [broken seals] [contamination]. Specifically, ***
Establishment of the reliability of the [container] [closure] supplier's report of analyses is deficient in that
the test results are not appropriately validated at appropriate intervals. Specifically, ***
Procedures are not established which are designed to assure that the responsible officials of the firm, if
they are not personally involved in or immediately aware of such actions, are notified in writing of
[investigations conducted] [recalls] [reports of inspectional observations issued by FDA] [any regulatory
actions brought by FDA relating to good manufacturing practices]. Specifically, ***
The persons [performing] [double-checking] the cleaning and maintenance are not [dating] [signing or
initialing] the equipment cleaning and use log. Specifically, ***
The batch production and control records are deficient in that they do not include the identity of major
[equipment] [lines] used. Specifically, ***
The master production and control records are deficient in that they do not include the [name]
[strength] of the drug product and a description of the dosage form. Specifically, ***
Laboratory records are deficient in that they do not include a complete record of all data obtained during
testing. Specifically, ***
The production area air supply lacks an appropriate air filtration system. Specifically, ***
Adequate exhaust systems or other systems to control contaminants are lacking in areas where air
contamination occurs during production. Specifically, ***
Air-handling systems for the [manufacture] [processing] [packing] of penicillin are not completely
separate from those for other drug products for human use. Specifically, ***
Components for drug product manufacturing are not [weighed] [measured] [subdivided as appropriate].
Specifically, ***
Each component is not added to the batch by one person and verified by a second person.. Specifically,
***
The in process control procedures were deficient in that they did not include an examination of the
adequacy of mixing to assure uniformity and homogeneity. Specifically, ***
In-process materials are not tested for [identity] [strength] [quality] [purity] and approved or rejected by
the quality control unit [during the production process] [after storage for long periods]. Specifically, ***
Drug product samples are not [representative of the entire batch] [properly identified]. Specifically, ***
Evidence of reserve drug product sample deterioration was not [investigated] [recorded and maintained
with other stability data]. Specifically, ***
A written record of the program along with appropriate validation data has not been maintained in
situations where backup data is eliminated by computerization or other automated processes.
Specifically, ***
Each lot of [components] [drug product containers] [closures] was not appropriately identified as to its
status in terms of being quarantined, approved or rejected. Specifically, ***
Samples taken to determine conformance to appropriate written specifications for the acceptance of
each lot within each shipment of [components] [drug product containers] [closures] [labeling] are not
[representative] [adequately identified]. Specifically, ***
Written procedures for sampling and testing plans are not followed for each drug product. Specifically,
***
The reserve sample of drug product does not consist of at least twice the quantity necessary to perform
all the required tests of drug product. Specifically, ***
Batch production and control records for each batch of drug product produced do not include an accurate
reproduction of the appropriate master production or control record which was checked for accuracy,
dated and signed. Specifically, ***
Batch production and control records do not include results of the inspection of the packaging and
labeling area [before] [after] use for each batch of drug product produced. Specifically, ***
Written complaint records do not include, where known, [the name and strength of the drug product]
[lot number] [name of complainant] [nature of complaint] [reply to complainant]. Specifically, ***
A written record of each complaint is not maintained in a file designated for drug product complaints [at
the facility where the drug product was manufactured, processed or packed] [at a facility other than the
facility in which the drug product was manufactured, processed or packed provided the written records
are readily available for inspection at that other facility]. Specifically, ***
Records maintained of any modification of an established method employed in testing do not include [the
reason for the modification] [the data to verify that the modification produced results that are at least as
accurate and reliable for the material being tested as the established method]. Specifically, ***
Laboratory records do not include a statement of [each method used in the testing of a sample] [the
location of data that establish that the methods used in the testing of the sample meet proper standards
of accuracy and reliability as applied to the product tested]. Specifically, ***
Returned drug products held, stored or shipped before or during their return under conditions which cast
doubt on their safety, identity, strength, quality or purity are not [destroyed] [subjected to examination,
testing or other investigation to prove the drug products do meet all the necessary parameters].
Specifically, ***
Returned drug products were reprocessed without assuring that the subsequent drug product met the
appropriate standards of safety, identity, strength, quality and purity. Specifically, ***
Adverse drug experiences that were the subject of post marketing 15-day reports were not [promptly]
investigated. Specifically, ***
Periodic reports of non-alert adverse drug experiences have not been submitted [quarterly for an
application which was approved less than three years ago] [yearly for an application which was approved
three or more years ago]. Specifically, ***
Not all periodic reports contained [a narrative summary and analysis of the information in the report] [an
analysis of the post marketing 15-day Alert reports submitted during the reporting interval] [an FDA Form
3500A for each adverse drug experience not reported as a post marketing 15-day Alert report] [an index
containing a line listing of your patient identification number and adverse reaction term(s)] [a history of
actions taken since the last report because of adverse drug experiences]. Specifically, ***
Serious adverse event(s) for a non-prescription drug used in the United States has not been reported to
the Secretary. Specifically, ***
You did not implement procedures to ensure that all your equipment is [properly installed] [maintained]
[capable of repeatedly producing valid results]. Specifically,***
You did not document your activities in accordance with your procedures for ensuring the equipment
suitability for its intended purposes. Specifically,***
You did not oversee production operations in a manner to ensure that each PET drug [meets the
requirements of the FD&C Act as to safety] [has the identity and strength that it is supposed to have]
[meets the quality and purity characteristics that it is supposed to have]. Specifically, ***
You did not [establish] [maintain] [follow] appropriate written procedures that describe the [receipt]
[login] [identification] [storage] [handling] [testing] [acceptance and/or rejection] of [components] [drug
product containers] [closures]. Specifically,***
You did not establish appropriate written specifications for the [identity] [quality] [purity] of components.
Specifically,***
You did not have written production and process control procedures to [ensure] [document] that [all key
process parameters are controlled] [any deviations from the procedures are justified]. Specifically,***
You did not keep a record of checks of the [production area] [all equipment in the production area] for
cleanliness and suitability immediately before use. Specifically,***
Each laboratory used to conduct testing of [components] [in-process materials] [finished PET drug
products] does not [have written procedures] [follow written procedures] for the conduct of each test.
Specifically,***
You did not document the [calibration] [inspection] [checking] [maintenance] of laboratory equipment.
Specifically,***
Each laboratory used to perform tests related to the production of a PET drug did not keep complete
records of all tests performed to ensure compliance with established specifications and standards,
including examinations and assays. Specifically,***
You did not [establish] [follow] procedures to ensure that a PET drug was not given final release before a
designated qualified individual authorized the final release by dated signature. Specifically,***
Consultants lack sufficient education, training and experience to advise on the subject for which they are
retained. Specifically, ***
Records are not maintained stating the consultant's [name] [address] [qualifications] [type of service
provided]. Specifically, ***
Procedures for the cleaning and maintenance of equipment are deficient regarding maintenance and
cleaning schedules, including, where appropriate, sanitizing schedules. Specifically, ***
Procedures for the cleaning and maintenance of equipment are deficient regarding sufficient detail of the
methods, equipment, and materials used in the cleaning and maintenance operation, and the methods of
disassembly and reassembling equipment as necessary to assure proper cleaning and maintenance.
Specifically, ***
Procedures for the cleaning and maintenance of equipment are deficient regarding the removal or
obliteration of the previous batch identification. Specifically, ***
Procedures for the cleaning and maintenance of equipment are deficient regarding inspection of the
equipment for cleanliness immediately before use. Specifically, ***
to the receipt, identification, storage, and withholding from use of [components] [drug product
containers] [closures] [labeling] pending sampling, testing, or examination by the quality control unit
before release for manufacturing or packaging. Specifically, ***
Failure to maintain a backup file of data entered into the computer or related system. Specifically, ***
Written production and control procedures include batches formulated with the intent to provide less
than 100 percent of the labeled or established amount of active ingredient. Specifically, ***
Component [weighing] [measuring] [subdividing] operations are not adequately supervised. Specifically,
***
to the holding of rejected [components] [drug product containers] [closures] [labeling] before disposition.
Specifically,***
The batch records do not record the distinctive [identification number] [code] [name of equipment] to
identify major equipment to show the specific equipment used in the manufacture of a batch of a drug
to the quarantine storage of drug products prior to release. Specifically, ***
Aseptic processing areas are deficient regarding [temperature] [humidity] controls. Specifically, ***
Aseptic processing areas are deficient regarding systems for maintaining any equipment used to control
the aseptic conditions. Specifically, ***
Printing devices used to imprint labeling upon the drug product [unit label] [case] are not monitored to
assure that all imprinting conforms to the print specified in the batch production record. Specifically, ***
There is a lack of rotation so that the oldest approved stock of [components] [drug product containers]
[closures] is used first. Specifically, ***
The distinctive code for each lot of [components] [drug product containers] [closures] is not used in
recording the disposition of each lot. Specifically, ***
Each lot in each shipment received was not identified with a distinctive code for each container or
grouping of containers for [components] [drug product containers] [closures]. Specifically, ***
The containers of components, or drug product containers or closures which are sampled are not opened
in a manner to prevent [contamination of their contents] [contamination of other components]
[contamination of other drug product containers] [contamination of other closures]. Specifically, ***
Sample container identification of sampled item is deficient in that it does not include the [name of the
material sampled] [lot number] [container from which the sample was taken] [date on which the sample
was taken] [name of the person who collected the sample]. Specifically, ***
Drug product container and closure test procedures are deficient in that [containers] [closures] are not
tested for conformance in accordance with appropriate written procedures. Specifically, ***
Each lot of a [component] [drug product containers] [closures] liable to objectionable microbiological
contamination is deficiently subjected to microbiological tests before use. Specifically, ***
Drug product containers or closures are [reactive] [additive] [absorptive] so as to alter the safety, identity,
strength, quality, and purity of the drug beyond the official or established requirements. Specifically, ***
There are no written [standards or specifications] [methods of testing] [methods of cleaning] [methods of
sterilization] [methods of processing] to remove pyrogenic properties. Specifically, ***
Each batch of controlled-release dosage form drug product is not laboratory tested to determine
conformance to the specifications for the rate of release for each active ingredient. Specifically, ***
Suitable reader or photocopying equipment was not made readily available for [drug product]
[component] records maintained using reduction techniques. Specifically, ***
The procedures for the annual quality standards record evaluation are deficient in that they do not
address a review of [complaint] [recall] [returned drug product] [salvaged drug product] [investigation]
records for each drug product. Specifically, ***
The records for [components] [drug product containers or closures] [labeling] do not include the
[identity and quantity of each shipment of each lot] [name of the supplier] [supplier's lot number]
[receiving code] [date of receipt] [name of the prime manufacturer if different from the supplier]
[location of the prime manufacturer]. Specifically, ***
The batch production and control records are deficient in that they do not include [complete labeling
control records] [specimen] [copy] of labeling. Specifically, ***
The batch production and control records are deficient in that they do not include identification of
persons [performing] [supervising] [checking] each significant step in the operation. Specifically, ***
The master production and control records are deficient in that they lack a justification for the variation in
the amount of components used in the preparation of a dosage form. Specifically, ***
The master production and control records are deficient in that they do not include a statement
concerning any calculated excess of component. Specifically, ***
Laboratory records are deficient in that they do not include all calculations performed during testing.
Specifically, ***
Laboratory records are deficient in that they do not include the [initials] [signature] of the second person
reviewing the record for accuracy. Specifically, ***
Complaint procedures are deficient in that they do not include provisions that allow for the review and
determination of an investigation by the quality control unit. Specifically, ***
Complaint procedures are deficient in that written complaint files are not maintained at the
manufacturing site nor were they readily available from their off-site location. Specifically, ***
Complaint records are deficient in that they do not document the reason and the individual making the
decision not to conduct a complaint investigation. Specifically, ***
The potable water being permitted for use in the potable water system fails to meet standards
prescribed by the Environmental Protection Agency. Specifically, ***
Washing and toilet facilities are not [provided] [easily accessible to working areas]. Specifically, ***
Specific identification tests are not conducted on components that have been accepted based on the
supplier's report of analysis. Specifically, ***
The packaging and labeling operation involving cut labels and relying on visual inspection does not
provide for [100-percent examination for correct labeling during or after completion of finishing
operations for hand-applied labeling] [examination to be performed by one person and independently
verified by a second person]. Specifically, ****
Drug product reserve samples are not stored in [the same immediate container-closure system as the
marketed product] [an immediate container-closure system that has essentially the same characteristics
as the marketed product]. Specifically, ***
Failure to use [sterile equipment] [aseptic sampling techniques] when necessary in collecting a sample.
Specifically, ***
Containers from which samples have been taken are not marked to show that samples have been taken
from them. Specifically, ***
Containers and closures are not tested for conformance with all appropriate written procedures.
Specifically, ***
Each container of component dispensed to manufacturing is not examined by a second person to assure
that [the component was released by the quality control unit] [the weight or measure is correct as stated
in the batch records] [the containers are properly identified]. Specifically, ***
Control procedures fail to include [tablet or capsule weight variation] [disintegration time] [adequacy of
mixing to assure uniformity and homogeneity] [dissolution time and rate] [clarity, completeness or pH of
solutions]. Specifically,***
Samples taken of in-process materials for determination of conformance to specifications are not
[representative] [properly identified]. Specifically, ***
The statistical quality control criteria fail to include appropriate [acceptance levels] [rejection levels].
Specifically, ***
Batch production and control records do not include a record of any sampling performed, for each batch
of drug product produced. Specifically, ***
Batch production and control records do not include [in-process] [laboratory control] results for each
batch of drug product produced. Specifically, ***
Batch production and control records do not include the weights and measures of components used in
the course of processing each batch of drug product produced. Specifically, ***
Batch production and control records do not include dates of each significant step in the [manufacture]
[processing] [packing] [holding] of the batch for each batch of drug product produced. Specifically, ***
Written procedures describing the handling of all written and oral complaints do not include provisions
for review to determine whether the complaint represents a serious and unexpected adverse drug
experience which is required to be reported to the Food and Drug Administration. Specifically, ***
Records or copies of records were not made available for photocopying or other means of reproduction.
Specifically, ***
Laboratory records do not include a statement of the results of tests and how the results compare with
established standards of identity, strength, quality, and purity for the [component] [drug product
container] [closure] [in-process material] [drug product] tested. Specifically, ***
Laboratory records do not include [the initials or signature of the person who performs each test] [the
date(s) the tests were performed]. Specifically, ***
Records of returned drug products are not maintained. Specifically, ***
You, as a non-applicant, elected to submit to the applicant (rather than to FDA) all reports of adverse drug
experiences that were both serious and unexpected. However, you did not submit each report to the
applicant [within five calendar days of your receipt of the information]. Specifically, ***
Each post marketing 15-day Alert report submitted to FDA did not have its contents prominently
identified, i.e. [post marketing 15-day report] [post marketing 15-day report follow-up]. Specifically, ***
Individual ADEs which were not reported to FDA in a post marketing 15-day alert have not been included
in a periodic safety report. Specifically, ***
Not all post marketing 15-day Alert reports based upon scientific literature were accompanied by a copy
of the published article. Specifically, ***
Fifteen-day Alert reports have not been submitted for all adverse drug experiences during post marketing
studies, where there was a reasonable possibility that the drug caused the adverse experience.
Specifically, ***
An annual report did not include a full description of the manufacturing and control changes not
requiring a supplemental application, listed by date in the order in which they were implemented.
Specifically, ***
An annual report did not include a status report for all post marketing studies being performed by, or on
behalf of, the applicant and not covered by the requirements of 21 CFR 314.81(b)(2)(vii). Specifically, ***
During a field examination of drug products at your facility the following [was] [were] observed:
You did not document your activities in accordance with your procedures for cleaning all of your
equipment. Specifically,***
Your equipment is not [constructed] [maintained] so that surfaces that contact [components] [in-process
materials] [PET drugs] are not reactive, additive, or absorptive so as to alter the quality of the PET drugs.
Specifically,***
You did not approve or reject [components] [containers] [closures] [in-process materials] [packaging
materials] [labeling] [finished dosage forms] in a manner that ensures compliance with procedures and
specifications affecting the identity, strength, quality or purity of a PET drug. Specifically,***
You did not approve or reject, before implementation, proposed changes to existing [specifications]
[methods] [processes] [procedures] to ensure that they would maintain the identity, strength, quality and
purity of a PET drug. Specifically,***
You did not review production records to determine whether errors had occurred. Specifically,***
Your written procedures are not adequate to ensure that the [components] [containers] [closures] are
suitable for their intended use. Specifically,***
Your master production and control records did not contain a statement of action limits on radiochemical
yield. Specifically,***
Your master production and control records did not contain [complete production and control
instructions] [complete sampling and testing procedures] [complete specifications] [special notations]
[precautions to be followed]. Specifically,***
Your master production and control records did not contain [a description of the PET drug product
containers, closures and packaging materials] [a specimen or copy of each label and all other labeling].
Specifically,***
Your batch production records do not [always] include each major production step (obtained from the
approved appropriate master production and control record). Specifically,***
You did not document your process verification [activities] [results]. Specifically,***
Your [reagents] [solutions] [supplies] used in your testing procedures are not adequately controlled.
Specifically,***
All equipment used to perform the testing is not [suitable for its intended purposes] [capable of
producing valid results]. Specifically,***
Laboratory test records did not contain the initials or signature of the person performing the test.
Specifically,***
The samples tested for stability were [not representative of the lot or batch from which they were
obtained] [not stored under suitable storage conditions]. Specifically,***
The stability test results were not [documented] [used in determining appropriate storage conditions]
[used in determining appropriate expiration dates and times] for each PET drug product you produce.
Specifically,***
You did not establish [adequate] specifications for each PET drug product, including criteria for
determining [identity, strength, quality and purity] [sterility] [pyrogens]. Specifically,***
You implemented a new test procedure in a specification, but you did not first [establish] [document] the
[accuracy] [sensitivity] [specificity] [reproducibility] of the procedure. Specifically,***
You did not conduct an appropriate laboratory determination to ensure that each batch of a PET drug
conforms to specifications before final release. Specifically,***
A sample for sterility testing was held longer than 30 hours, but you did not demonstrate that the longer
period did not adversely affect the sample and that the test results obtained were equivalent to test
results that would have been obtained if the test had been started within the 30 hour period.
Specifically,***
You did not reject the batch of a PET drug product that did not conform to specifications. Specifically,***
You did not [completely] document the investigation of a PET drug product that did not meet
specifications. Specifically,***
You did not take [appropriate] action to correct any identified problems to prevent recurrence of a
nonconforming product or other quality problem. Specifically,***
Labeling and packaging operations for PET drug products were not controlled to prevent labeling and
product mix-ups. Specifically,***
You have not [developed] [followed] written procedures for the receipt and handling of all complaints
concerning the quality or purity of, or possible adverse reactions to, a PET drug product. Specifically,***
All records including those not stored at your inspected establishment are not [legible] [stored to prevent
deterioration or loss] [readily available for review and copying by FDA employees]. Specifically,***
You did not notify all facilities that received a PET drug product that failed to meet a criterion for sterility
of the findings from your investigation. Specifically***
You did not [establish] [follow] procedures to investigate the cause(s) of the nonconforming batch(s) of a
PET drug product. Specifically, ***
You did not document [the results of the investigation] [what happened to the rejected PET drug product]
for a PET drug product that did not meet specifications. Specifically***
Frequency
155
131
106
99
77
76
71
66
65
62
59
56
56
53
49
44
44
43
39
38
36
34
34
32
31
31
29
28
28
28
27
26
26
26
26
26
26
26
26
25
25
25
24
23
22
21
20
20
20
18
18
18
18
17
17
17
17
17
17
16
16
16
15
15
15
15
15
15
14
14
14
14
13
13
13
13
13
13
12
12
12
12
12
12
12
12
12
12
11
11
11
11
11
10
8
8
6
6
5
5
4
4
4
4
3
3
3
3
2
2
2
2
2
2
1
1
1
1
1
1
1
1
1
1
1
1
1
Foods 1560 21 CFR 110.35(c)
Foods 1524 21 CFR 123.11(b)
Foods 1306 21 CFR 110.20(b)(7)
Foods 905 21 CFR 123.6(b)
Foods 959 21 CFR 123.6(c)(1)
Foods 1422 21 CFR 110.20(b)(4)
Foods 960 21 CFR 123.6(c)(2)
Foods 904 21 CFR 123.6(b)
Foods 1552 21 CFR 110.35(a)
Foods 1525 21 CFR 123.11(c)
Foods 961 21 CFR 123.6(c)(3)
Foods 963 21 CFR 123.6(c)(5)
Foods 1581 21 CFR 110.37(e)
Foods 1695 21 CFR 110.80(b)(2)
Foods 6004 21 CFR 123.6(c)(4)

Foods 1287 21 CFR 110.20(a)(1)
Foods 1554 21 CFR 110.35(a)
Foods 1701 21 CFR 110.80(b)(7)
Foods 1689 21 CFR 110.80
Foods 1553 21 CFR 110.35(a)
Foods 1597 21 CFR 110.37(b)(3)
Foods 1427 21 CFR 110.20(b)(5)
Foods 2386 21 CFR 110.80(a)(1)
Foods 990 21 CFR 110.10(b)(3)
Foods 908 21 CFR 123.6(d)
Foods 1405 21 CFR 110.10(b)(6)
Foods 1562 21 CFR 110.35(d)
Foods 1125 21 CFR 110.40(a)
Foods 6008 21 CFR 123.8(a)(3)
Foods 6020 21 CFR 123.9(a)
Foods 945 21 CFR 123.12(a)(2)
Foods 1556 21 CFR 110.35(b)(2)
Foods 15858 21 CFR 111.75(a)(1)(i)

Foods 2392 21 CFR 110.80(b)(1)
Foods 1424 21 CFR 110.20(b)(4)
Foods 1066 21 CFR 110.40(b)
Foods 6005 21 CFR 123.6(c)(6)
Foods 15797 21 CFR 111.553
Foods 15869 21 CFR 111.75(c)
Foods 1615 21 CFR 110.93
Foods 6021 21 CFR 123.10
Foods 1007 21 CFR 110.10(b)(9)
Foods 15839 21 CFR 111.70(e)
Foods 3652 21 CFR 110.37(e)(1)
Foods 15861 21 CFR 111.75(a)(2)(ii)(A)
Foods 1292 21 CFR 110.20(b)(1)
Foods 15762 21 CFR 111.205(a)
Foods 933 21 CFR 123.8(a)(2)(ii)
Foods 3661 21 CFR 110.37(e)(5)
Foods 15659 21 CFR 111.475(b)(1)
Foods 15927 21 CFR 111.103
Foods 901 21 CFR 123.6(a)

Foods 15532 21 CFR 111.255(b)
Foods 985 21 CFR 110.10(b)(1)
Foods 1599 21 CFR 110.37(b)(5)
Foods 6018 21 CFR 123.7(a)
Foods 1006 21 CFR 110.10(b)(8)
Foods 1173 21 CFR 110.40(f)
Foods 1698 21 CFR 110.80(b)(5)
Foods 3658 21 CFR 110.37(e)(2)
Foods 1702 21 CFR 110.80(b)(8)
Foods 4470 21 CFR 108.25(c)(2)
Foods 6001 21 CFR 123.11(b)
Foods 1571 21 CFR 110.35(d)(5)
Foods 15641 21 CFR 111.453
Foods 1406 21 CFR 110.10(b)(6)
Foods 3659 21 CFR 110.37(e)(3)
Foods 1402 21 CFR 110.10(b)(4)
Foods 15830 21 CFR 111.70(b)(2)
Foods 15809 21 CFR 111.570(b)(1)
Foods 1005 21 CFR 110.10(b)(7)
Foods 1126 21 CFR 110.40(a)
Foods 3643 21 CFR 110.10(b)(5)

Foods 1429 21 CFR 110.20(b)(6)
Foods 1426 21 CFR 110.20(b)(5)
Foods 16042 21 CFR 111.503
Foods 9931 21 CFR 120.6(b)
Foods 6015 21 CFR 123.6(c)(6)
Foods 15829 21 CFR 111.70(b)(1)
Foods 16057 21 CFR 111.535(b)(1)
Foods 1067 21 CFR 110.40(c)
Foods 15897 21 CFR 111.83(a)
Foods 1293 21 CFR 110.20(b)(2)
Foods 1709 21 CFR 110.80(b)(13)
Foods 3071 21 CFR 114.80(a)(1)
Foods 15531 21 CFR 111.255(a)
Foods 3086 21 CFR 114.100(b)
Foods 3656 21 CFR 110.37(d)(3)
Foods 15763 21 CFR 111.205(a)
Foods 906 21 CFR 123.6(b)

Foods 3078 21 CFR 114.80(b)
Foods 3654 21 CFR 110.37(d)(1)
Foods 1578 21 CFR 110.37(f)
Foods 1763 21 CFR 110.35(b)(1)
Foods 4464 21 CFR 108.25(c)(1)
Foods 1172 21 CFR 110.40(e)
Foods 1602 21 CFR 110.37(a)
Foods 931 21 CFR 123.8(d)
Foods 3647 21 CFR 110.10(c)
Foods 6016 21 CFR 123.6(c)(7)
Foods 3080 21 CFR 114.83
Foods 6010 21 CFR 123.8(a)(3)(i)
Foods 15796 21 CFR 111.430(b)
Foods 1289 21 CFR 110.20(a)(3)
Foods 2361 21 CFR 110.80
Foods 6007 21 CFR 123.9(a)
Foods 1425 21 CFR 110.20(b)(4)
Foods 1570 21 CFR 110.35(d)(5)
Foods 1696 21 CFR 110.80(b)(3)
Foods 15747 21 CFR 111.210(g)

Foods 15828 21 CFR 111.70(a)
Foods 3062 21 CFR 114.10
Foods 3085 21 CFR 114.100(a)
Foods 4511 21 CFR 108.25(f)
Foods 6006 21 CFR 123.6(c)(7)
Foods 9930 21 CFR 120.6(c)
Foods 15838 21 CFR 111.70(d)
Foods 16013 21 CFR 111.140(b)(1)
Foods 16118 21 CFR 118.4
Foods 1403 21 CFR 110.10(b)(4)
Foods 1561 21 CFR 110.35(c)
Foods 6019 21 CFR 123.8(a)(2)
Foods 15790 21 CFR 111.403

Foods 16120 21 CFR 118.4
Foods 16204 21 CFR 118.10(b)(2)
Foods 913 21 CFR 123.8(a)(1)
Foods 1598 21 CFR 110.37(b)(4)
Foods 3075 21 CFR 114.80(a)(4)
Foods 12742 21 CFR 120.8(a)
Foods 15401 21 CFR 111.12(b)

Foods 918 21 CFR 123.8(a)
Foods 1090 21 CFR 110.40(d)
Foods 1596 21 CFR 110.37(b)(2)
Foods 2388 21 CFR 110.80(a)(5)
Foods 2393 21 CFR 110.80(b)(1)
Foods 3067 21 CFR 114.80(a)
Foods 4475 21 CFR 108.25(c)(3)(i)
Foods 4479 21 CFR 108.25(e)
Foods 9955 21 CFR 120.11(a)(1)
Foods 12745 21 CFR 120.8(b)(1)
Foods 12746 21 CFR 120.8(b)(2)
Foods 15410 21 CFR 111.14(b)(2)
Foods 15453 21 CFR 111.16
Foods 15492 21 CFR 111.25(a)
Foods 15736 21 CFR 111.353
Foods 16135 21 CFR 118.4(b)(4)
Foods 975 21 CFR 123.9(b)(1)
Foods 1130 21 CFR 110.40(a)
Foods 1132 21 CFR 110.40(a)

Foods 1316 21 CFR 113.87(c)
Foods 3655 21 CFR 110.37(d)(2)
Foods 3662 21 CFR 110.37(e)(6)
Foods 3877 21 CFR 113.60(c)
Foods 4515 21 CFR 108.35(c)(2)
Foods 15494 21 CFR 111.25(c)
Foods 15543 21 CFR 111.260(c)
Foods 15744 21 CFR 111.210(h)(2)
Foods 15862 21 CFR 111.75(a)(2)
Foods 986 21 CFR 110.10(b)(2)
Foods 1711 21 CFR 110.80(b)(15)
Foods 2394 21 CFR 110.80(b)(6)
Foods 3712 21 CFR 110.93
Foods 12748 21 CFR 120.8(b)(5)
Foods 12755 21 CFR 120.11(a)(1)(iv)
Foods 15402 21 CFR 111.12
Foods 15404 21 CFR 111.12(c)
Foods 15831 21 CFR 111.70(b)(3)

Foods 15853 21 CFR 111.73
Foods 15930 21 CFR 111.105
Foods 16203 21 CFR 118.10(b)(1)
Foods 16205 21 CFR 118.10(b)(3)
Foods 932 21 CFR 123.7(d)
Foods 3073 21 CFR 114.80(a)(2)
Foods 3660 21 CFR 110.37(e)(4)
Foods 6022 21 CFR 123.12(c)
Foods 12747 21 CFR 120.8(b)(3)
Foods 12749 21 CFR 120.8(b)(6)
Foods 15499 21 CFR 111.27(a)
Foods 15526 21 CFR 111.30(c)
Foods 15642 21 CFR 111.455(a)
Foods 15748 21 CFR 111.210(f)
Foods 15761 21 CFR 111.205(b)(1)
Foods 15825 21 CFR 111.65
Foods 15843 21 CFR 111.70(g)

Foods 15871 21 CFR 111.75(c)(2)
Foods 15921 21 CFR 111.95(b)(2)
Foods 15932 21 CFR 111.105(a)
Foods 16040 21 CFR 111.610(a)
Foods 16058 21 CFR 111.535(b)(2)
Foods 1472 21 CFR 113.83
Foods 1641 21 CFR 113.100(b)
Foods 1697 21 CFR 110.80(b)(4)
Foods 2396 21 CFR 110.80(b)(6)
Foods 3645 21 CFR 110.10(d)
Foods 9943 21 CFR 120.8(a)
Foods 9954 21 CFR 120.11(a)(1)(iv)
Foods 9958 21 CFR 120.12(c)
Foods 15496 21 CFR 111.27(b)
Foods 15498 21 CFR 111.27(d)
Foods 15746 21 CFR 111.210(h)(1)
Foods 15800 21 CFR 111.560(a)(2)

Foods 15872 21 CFR 111.75(c)(3)
Foods 15882 21 CFR 111.75(h)(2)
Foods 15989 21 CFR 111.127
Foods 16070 21 CFR 111.35(b)(2)
Foods 16140 21 CFR 118.4(c)(2)

Foods 1129 21 CFR 110.40(a)
Foods 9936 21 CFR 120.7(a)
Foods 9961 21 CFR 120.24(a)
Foods 15425 21 CFR 111.15(i)
Foods 15443 21 CFR 111.15(b)(2)
Foods 15544 21 CFR 111.260(d)
Foods 15560 21 CFR 111.260(k)(2)
Foods 15645 21 CFR 111.455(c)
Foods 15737 21 CFR 111.210(h)(5)
Foods 15784 21 CFR 111.410(c)
Foods 15819 21 CFR 111.55
Foods 15832 21 CFR 111.70(c)(1)
Foods 15986 21 CFR 111.123(b)(2)

Foods 16089 FDCA 417(d)(1)(A)
Foods 16134 21 CFR 118.4(b)(3)
Foods 16138 21 CFR 118.4(c)(1)
Foods 929 21 CFR 123.8(b)
Foods 972 21 CFR 123.8(a)(1)
Foods 1255 21 CFR 129.20(a)
Foods 1566 21 CFR 110.35(d)(4)
Foods 1568 21 CFR 110.35(d)(2)
Foods 1601 21 CFR 110.37(a)
Foods 1761 21 CFR 129.80(a)
Foods 2274 21 CFR 129.80(g)(1)
Foods 2384 21 CFR 110.80(a)(7)
Foods 3088 21 CFR 114.100(b)
Foods 3653 21 CFR 110.37(d)
Foods 4181 21 CFR 113.89
Foods 4519 21 CFR 108.35(c)(3)(i)
Foods 6014 21 CFR 123.6(c)(2)

Foods 6017 21 CFR 123.7(c)
Foods 9941 21 CFR 120.8(a)
Foods 9947 21 CFR 120.11(b)
Foods 12734 21 CFR 120.12(a)
Foods 15434 21 CFR 111.15(d)(2)
Foods 15442 21 CFR 111.15(b)(1)

Foods 15454 21 CFR 111.16
Foods 15546 21 CFR 111.260(f)
Foods 15559 21 CFR 111.260(k)(1)
Foods 15570 21 CFR 111.153
Foods 15583 21 CFR 111.155(d)(1)
Foods 15681 21 CFR 111.315(d)
Foods 15791 21 CFR 111.403
Foods 15840 21 CFR 111.70(e)
Foods 15841 21 CFR 111.70(f)
Foods 15885 21 CFR 111.77(a)
Foods 15928 21 CFR 111.103

Foods 16122 21 CFR 118.4(a)(2)(i)
Foods 16142 21 CFR 118.4(c)(3)
Foods 16152 21 CFR 118.5(a)
Foods 16179 21 CFR 118.8(a)
Foods 16195 21 CFR 118.10(a)(3)(iv)
Foods 1176 21 CFR 110.40(f)
Foods 1196 21 CFR 110.10(a)
Foods 1290 21 CFR 110.20(a)(4)
Foods 1353 21 CFR 129.35(a)(3)(i)
Foods 1428 21 CFR 110.20(b)(6)
Foods 1766 21 CFR 110.35(b)(1)
Foods 2275 21 CFR 129.80(g)(2)
Foods 2385 21 CFR 110.80(a)(1)
Foods 3089 21 CFR 114.100(c)
Foods 3651 21 CFR 110.37(b)(5)
Foods 4062 21 CFR 113.100(a)

Foods 4421 21 CFR 110.20(a)
Foods 4518 21 CFR 108.35(c)(2)(ii)
Foods 4524 21 CFR 108.35(g)
Foods 9928 21 CFR 120.12(b)
Foods 9935 21 CFR 120.7(a)
Foods 15480 21 CFR 111.20(h)
Foods 15505 21 CFR 111.27(a)(3)(v)
Foods 15533 21 CFR 111.255(c)
Foods 15566 21 CFR 111.260(l)(3)
Foods 15733 21 CFR 111.365
Foods 15734 21 CFR 111.360
Foods 15759 21 CFR 111.205(b)(2)
Foods 15883 21 CFR 111.75(i)
Foods 15898 21 CFR 111.83(b)(1)
Foods 16149 21 CFR 118.4(e)
Foods 16206 21 CFR 118.10(b)(3)
Foods 950 21 CFR 123.12(d)

Foods 1040 21 CFR 113.10
Foods 1045 21 CFR 113.10
Foods 1471 21 CFR 113.83
Foods 1529 21 CFR 113.89
Foods 1642 21 CFR 113.100(b)
Foods 1688 21 CFR 110.80
Foods 1708 21 CFR 110.80(b)(12)
Foods 2362 21 CFR 110.80
Foods 2887 21 CFR 113.40(j)
Foods 3077 21 CFR 114.80(b)
Foods 3090 21 CFR 114.100(d)
Foods 3708 21 CFR 110.80(a)(1)
Foods 3709 21 CFR 110.80(a)(1)
Foods 4295 21 CFR 110.40(a)
Foods 4514 21 CFR 108.35(c)(1)
Foods 6009 21 CFR 123.8(a)(3)(iii)
Foods 9919 21 CFR 120.10(a)
Foods 9932 21 CFR 120.6(a)

Foods 12743 21 CFR 120.8(b)(4)
Foods 12751 21 CFR 120.8(b)(7)
Foods 15382 21 CFR 111.8
Foods 15491 21 CFR 111.25
Foods 15525 21 CFR 111.30(b)
Foods 15542 21 CFR 111.260(b)
Foods 15578 21 CFR 111.155(c)
Foods 15598 21 CFR 111.160(d)(1)
Foods 15623 21 CFR 111.180(b)(2)
Foods 15702 21 CFR 111.320(b)
Foods 15715 21 CFR 111.375(b)
Foods 15723 21 CFR 111.365(i)
Foods 15739 21 CFR 111.210(h)(3)(ii)(B)
Foods 15751 21 CFR 111.210(d)
Foods 15760 21 CFR 111.205(b)(1)
Foods 15774 21 CFR 111.415(f)(1)
Foods 15786 21 CFR 111.410(b)
Foods 15810 21 CFR 111.570(b)(2)
Foods 15860 21 CFR 111.75(a)(2)

Foods 15867 21 CFR 111.75(b)(1)
Foods 15893 21 CFR 111.80(c)
Foods 15902 21 CFR 111.83(b)(4)
Foods 15920 21 CFR 111.95(b)(1)
Foods 15954 21 CFR 111.113(a)(2)
Foods 15977 21 CFR 111.123(a)(1)
Foods 16014 21 CFR 111.140(b)(1)
Foods 16037 21 CFR 111.605
Foods 16047 21 CFR 111.510
Foods 16071 21 CFR 111.35(b)(3)
Foods 16132 21 CFR 118.4(b)(1)
Foods 938 21 CFR 123.9(c)
Foods 1351 21 CFR 129.35(a)(3)(i)
Foods 1423 21 CFR 129.37(d)
Foods 1453 21 CFR 129.40(a)(1)
Foods 1559 21 CFR 110.35(c)
Foods 1563 21 CFR 110.35(d)(1)
Foods 1577 21 CFR 110.37(f)
Foods 1600 21 CFR 110.37(a)
Foods 1651 21 CFR 113.40(a)(1)

Foods 2848 21 CFR 113.40(g)(1)(i)(b)
Foods 3082 21 CFR 114.89
Foods 4476 21 CFR 108.25(c)(3)(ii)
Foods 9939 21 CFR 120.7(c)
Foods 9981 21 CFR 120.12(b)(4)
Foods 12732 21 CFR 120.10(a)
Foods 15388 21 CFR 111.10(b)
Foods 15447 21 CFR 111.15(c)(3)
Foods 15452 21 CFR 111.15(f)(5)
Foods 15458 21 CFR 111.20(d)(1)(i)
Foods 15481 21 CFR 111.23(b)
Foods 15508 21 CFR 111.27(a)(5)(ii)
Foods 15547 21 CFR 111.260(g)
Foods 15550 21 CFR 111.260(j)
Foods 15556 21 CFR 111.260(j)(2)(iv)
Foods 15558 21 CFR 111.260(k)(1)

Foods 15562 21 CFR 111.260(l)(1)
Foods 15599 21 CFR 111.160(d)(1)
Foods 15662 21 CFR 111.303
Foods 15671 21 CFR 111.315
Foods 15698 21 CFR 111.320(a)
Foods 15740 21 CFR 111.210(h)(3)(ii)(A)
Foods 15743 21 CFR 111.210(h)(3)
Foods 15783 21 CFR 111.410(d)
Foods 15799 21 CFR 111.560(a)(1)
Foods 15834 21 CFR 111.70(c)(2)
Foods 15842 21 CFR 111.70(f)
Foods 15855 21 CFR 111.73
Foods 15864 21 CFR 111.75(a)(2)(ii)(C)
Foods 15865 21 CFR 111.75(a)(2)(ii)(D)
Foods 15870 21 CFR 111.75(c)(1)
Foods 15972 21 CFR 111.120(b)
Foods 15975 21 CFR 111.120(e)

Foods 15984 21 CFR 111.123(a)(8)
Foods 16172 21 CFR 118.7(a)
Foods 16192 21 CFR 118.10(a)(3)(1)
Foods 976 21 CFR 123.9(b)(2)
Foods 1317 21 CFR 113.87(d)
Foods 1330 21 CFR 113.100(a)
Foods 1467 21 CFR 129.40(a)(2)
Foods 1500 21 CFR 113.89
Foods 1643 21 CFR 113.100(c)
Foods 1648 21 CFR 113.40(a)(1)
Foods 1669 21 CFR 110.80(a)(3)
Foods 1670 21 CFR 110.80(a)(4)
Foods 1764 21 CFR 129.80(b)(1)
Foods 1812 21 CFR 129.80(c)
Foods 2391 21 CFR 110.80(a)(6)
Foods 2427 21 CFR 110.80(b)(9)
Foods 2837 21 CFR 113.40(g)(4)
Foods 3093 21 CFR 114.89

Foods 3857 21 CFR 113.60(a)
Foods 3872 21 CFR 113.60(a)(3)
Foods 4296 21 CFR 110.80(a)(5)
Foods 4520 21 CFR 108.35(c)(3)(ii)
Foods 6012 21 CFR 123.8(a)(3)(iii)
Foods 9926 21 CFR 120.14(a)
Foods 9929 21 CFR 120.12(b)(4)
Foods 9986 21 CFR 120.24(c)
Foods 12709 21 CFR 129.80(c)
Foods 12744 21 CFR 120.8(b)(4)
Foods 15396 21 CFR 111.10(b)(6)
Foods 15405 21 CFR 111.13(a)
Foods 15409 21 CFR 111.14(b)(1)
Foods 15433 21 CFR 111.15(d)(1)
Foods 15469 21 CFR 111.20(c)(3)
Foods 15493 21 CFR 111.25(b)
Foods 15524 21 CFR 111.30(a)
Foods 15589 21 CFR 111.160(c)

Foods 15619 21 CFR 111.180(b)(1)
Foods 15620 21 CFR 111.180(b)(1)
Foods 15648 21 CFR 111.465(a)(2)
Foods 15652 21 CFR 111.465(b)

Foods 15660 21 CFR 111.475(b)(2)
Foods 15665 21 CFR 111.303
Foods 15675 21 CFR 111.315(b)
Foods 15677 21 CFR 111.315(b)(1)
Foods 15732 21 CFR 111.365(a)
Foods 15741 21 CFR 111.210(h)(3)(i)
Foods 15772 21 CFR 111.415(g)
Foods 15801 21 CFR 111.560(b)
Foods 15817 21 CFR 111.570(b)(2)(ii)(F)
Foods 15820 21 CFR 111.55
Foods 15845 21 CFR 111.73
Foods 15891 21 CFR 111.80(a)
Foods 15903 21 CFR 111.87
Foods 15908 21 CFR 111.90(b)(1)
Foods 15944 21 CFR 111.105(i)

Foods 15945 21 CFR 111.105(i)
Foods 15953 21 CFR 111.113(a)(1)
Foods 15955 21 CFR 111.113(a)(3)
Foods 15964 21 CFR 111.113(c)
Foods 15965 21 CFR 111.117
Foods 15983 21 CFR 111.123(a)(7)
Foods 15995 21 CFR 111.127(d)
Foods 16038 21 CFR 111.605(b)
Foods 16045 21 CFR 111.503
Foods 16068 21 CFR 111.35(b)(1)(iii)
Foods 16117 21 CFR 118.4
Foods 16133 21 CFR 118.4(b)(2)
Foods 16141 21 CFR 118.4(c)(2)
Foods 16191 21 CFR 118.10(a)(2)
Foods 16193 21 CFR 118.10(a)(3)(ii)
Foods 16194 21 CFR 118.10(a)(3)(iii)
Foods 899 21 CFR 123.16
Foods 949 21 CFR 123.12(c)
Foods 1093 21 CFR 110.40(g)

Foods 1188 21 CFR 110.37(c)
Foods 1258 21 CFR 113.60(c)
Foods 1273 21 CFR 129.20(b)
Foods 1278 21 CFR 129.20(d)
Foods 1329 21 CFR 113.100(a)
Foods 1359 21 CFR 129.35(a)(3)(i)
Foods 1394 21 CFR 129.37(a)
Foods 1483 21 CFR 113.87(a)
Foods 1499 21 CFR 113.89
Foods 1595 21 CFR 110.37(b)(1)
Foods 1660 21 CFR 113.40(a)(1)
Foods 1710 21 CFR 110.80(b)(14)
Foods 1731 21 CFR 113.40(a)(2)
Foods 1734 21 CFR 113.40(a)(2)
Foods 1752 21 CFR 113.40(a)(8)
Foods 1806 21 CFR 129.80(b)(1)
Foods 1944 21 CFR 129.80(d)
Foods 1962 21 CFR 129.80(h)
Foods 2154 21 CFR 113.40(b)(2)

Foods 2273 21 CFR 129.80(g)
Foods 2284 21 CFR 129.80(f)
Foods 2387 21 CFR 110.80(a)(1)
Foods 2389 21 CFR 110.80(a)(5)
Foods 2502 21 CFR 113.40(e)(2)
Foods 2514 21 CFR 113.40(e)(7)
Foods 2838 21 CFR 113.40(g)(1)(i)(a)
Foods 2898 21 CFR 113.40(g)(2)(ii)(c)
Foods 3068 21 CFR 114.80(a)(1)
Foods 3072 21 CFR 114.80(a)(1)
Foods 3079 21 CFR 114.80(b)
Foods 3083 21 CFR 114.89
Foods 3650 21 CFR 110.35(d)(1)
Foods 3657 21 CFR 110.37(d)(4)
Foods 3856 21 CFR 113.60(a)
Foods 3864 21 CFR 113.60(a)(1)
Foods 3876 21 CFR 113.60(c)
Foods 3885 21 CFR 113.87(c)

Foods 4178 21 CFR 113.83
Foods 6002 21 CFR 123.11(b)
Foods 9946 21 CFR 120.11(b)
Foods 12733 21 CFR 120.11(a)(1)(iv)(C)
Foods 12736 21 CFR 120.12(e)
Foods 12750 21 CFR 120.8(b)(6)
Foods 15302 21 CFR 120.11(a)(2)
Foods 15304 21 CFR 120.12(g)
Foods 15305 21 CFR 120.14(a)(2)
Foods 15395 21 CFR 111.10(b)(5)
Foods 15423 21 CFR 111.15(j)
Foods 15429 21 CFR 111.15(k)
Foods 15437 21 CFR 111.15(a)(1)
Foods 15450 21 CFR 111.15(f)(3)
Foods 15468 21 CFR 111.20(c)(2)
Foods 15501 21 CFR 111.27(a)(3)(i)
Foods 15511 21 CFR 111.27(d)
Foods 15529 21 CFR 111.30(e)

Foods 15545 21 CFR 111.260(e)
Foods 15548 21 CFR 111.260(h)
Foods 15552 21 CFR 111.260(j)(2)
Foods 15554 21 CFR 111.260(j)(2)(ii)
Foods 15557 21 CFR 111.260(k)
Foods 15564 21 CFR 111.260(l)(1)(ii)
Foods 15567 21 CFR 111.260(l)(4)
Foods 15569 21 CFR 111.260(n)
Foods 15572 21 CFR 111.153
Foods 15573 21 CFR 111.153
Foods 15579 21 CFR 111.155(c)(1)
Foods 15585 21 CFR 111.155(d)(2)
Foods 15586 21 CFR 111.155(e)
Foods 15606 21 CFR 111.165(c)(1)
Foods 15607 21 CFR 111.165(c)(2)
Foods 15626 21 CFR 111.180(b)(3)
Foods 15646 21 CFR 111.460(a)
Foods 15728 21 CFR 111.365(d)
Foods 15745 21 CFR 111.210(h)(1)
Foods 15749 21 CFR 111.210(e)

Foods 15750 21 CFR 111.210(d)
Foods 15752 21 CFR 111.210(c)
Foods 15754 21 CFR 111.210(a)
Foods 15768 21 CFR 111.420(c)
Foods 15769 21 CFR 111.420(b)
Foods 15779 21 CFR 111.415(a)
Foods 15785 21 CFR 111.410(b)
Foods 15788 21 CFR 111.410(a)
Foods 15803 21 CFR 111.560
Foods 15850 21 CFR 111.73
Foods 15878 21 CFR 111.75(e)
Foods 15886 21 CFR 111.77(b)
Foods 15892 21 CFR 111.80(b)
Foods 15894 21 CFR 111.80(d)
Foods 15940 21 CFR 111.105(h)
Foods 15950 21 CFR 111.110(b)
Foods 15951 21 CFR 111.110(c)
Foods 15963 21 CFR 111.113(b)(2)

Foods 15973 21 CFR 111.120(c)
Foods 15976 21 CFR 111.123
Foods 15998 21 CFR 111.127(g)
Foods 16000 21 CFR 111.130
Foods 16001 21 CFR 111.130(a)
Foods 16004 21 CFR 111.130(b)
Foods 16020 21 CFR 111.140 (b)(3)(ii)
Foods 16067 21 CFR 111.35(b)(1)(ii)
Foods 16083 21 CFR 111.35(b)(6)
Foods 16087 21 CFR 111.123(b)(4)
Foods 16131 21 CFR 118.4(b)
Foods 16136 21 CFR 118.4(b)(5)
Foods 16183 21 CFR 118.9
Foods 16189 21 CFR 118.10(c)
Foods 16190 21 CFR 118.10(a)(1)
Foods 16196 21 CFR 118.10(a)(3)(v)
Foods 16201 21 CFR 118.10(d)
Foods 16207 21 CFR 118.10(b)(4)
Foods 939 21 CFR 123.9(f)

Foods 1044 21 CFR 113.10
Foods 1197 21 CFR 110.10(a)
Foods 1286 21 CFR 129.35(a)
Foods 1288 21 CFR 110.20(a)(2)
Foods 1303 21 CFR 113.81(f)
Foods 1324 21 CFR 113.100(d)
Foods 1325 21 CFR 113.100(e)
Foods 1334 21 CFR 113.100(a)(4)
Foods 1379 21 CFR 129.35(a)(4)(iv)
Foods 1383 21 CFR 129.35(c)
Foods 1401 21 CFR 129.37(a)
Foods 1412 21 CFR 129.37(b)
Foods 1417 21 CFR 129.37(c)
Foods 1473 21 CFR 113.83
Foods 1484 21 CFR 113.87(a)

Foods 1486 21 CFR 113.87(b)
Foods 1531 21 CFR 113.100(a)(6)
Foods 1532 21 CFR 113.100(a)(7)
Foods 1533 21 CFR 113.100(b)
Foods 1569 21 CFR 110.35(d)(2)
Foods 1640 21 CFR 113.100(b)
Foods 1645 21 CFR 113.100(c)
Foods 1653 21 CFR 113.40(a)(1)
Foods 1665 21 CFR 110.80(a)(2)
Foods 1706 21 CFR 110.80(b)(10)
Foods 1732 21 CFR 113.40(a)(2)
Foods 1735 21 CFR 113.40(a)(2)
Foods 1740 21 CFR 113.40(a)(2)
Foods 1757 21 CFR 113.40(a)(8)
Foods 1762 21 CFR 129.80(a)
Foods 1855 21 CFR 113.40(a)(12)
Foods 1865 21 CFR 113.40(a)(12)
Foods 2101 21 CFR 113.40(a)(13)
Foods 2105 21 CFR 113.40(a)(13)(iv)
Foods 2111 21 CFR 113.40(b)(4)

Foods 2142 21 CFR 113.40(b)(1)
Foods 2143 21 CFR 113.40(b)(1)
Foods 2145 21 CFR 113.40(b)(1)
Foods 2149 21 CFR 113.40(b)(1)
Foods 2151 21 CFR 113.40(b)(2)
Foods 2152 21 CFR 113.40(b)(2)
Foods 2153 21 CFR 113.40(b)(2)
Foods 2169 21 CFR 113.40(b)(9)
Foods 2271 21 CFR 129.80(e)
Foods 2272 21 CFR 129.80(e)
Foods 2298 21 CFR 129.80(f)
Foods 2344 21 CFR 113.40(c)(7)

Foods 2390 21 CFR 110.80(a)(6)
Foods 2428 21 CFR 110.80(b)(9)
Foods 2496 21 CFR 113.40(e)(1)
Foods 2499 21 CFR 113.40(e)(2)
Foods 2503 21 CFR 113.40(e)(2)
Foods 2840 21 CFR 113.40(g)(1)(i)(a)
Foods 2846 21 CFR 113.40(g)(1)(i)(b)
Foods 2856 21 CFR 113.40(g)(1)(i)(e)
Foods 2860 21 CFR 113.40(g)(1)(i)(f)

Foods 2862 21 CFR 113.40(g)(1)(i)(g)
Foods 2869 21 CFR 113.40(g)(1)(ii)(e)
Foods 2870 21 CFR 113.40(g)(1)(ii)(e)
Foods 2885 21 CFR 113.40(i)
Foods 2886 21 CFR 113.40(i)
Foods 2890 21 CFR 113.40(g)(2)(i)(a)
Foods 3092 21 CFR 114.89
Foods 3648 21 CFR 110.20(a)(4)
Foods 3710 21 CFR 110.80(b)(16)
Foods 3869 21 CFR 113.60(a)(1)(ii)
Foods 3873 21 CFR 113.60(a)(3)
Foods 3887 21 CFR 113.89
Foods 3892 21 CFR 113.60(a)
Foods 4067 21 CFR 113.40(a)(12)(iii)

Foods 4179 21 CFR 113.83
Foods 4477 21 CFR 108.25(d)
Foods 4512 21 CFR 108.25(g)
Foods 4521 21 CFR 108.35(d)
Foods 4522 21 CFR 108.35(e)
Foods 4523 21 CFR 108.35(f)
Foods 4529 21 CFR 108.35(c)(2)(ii)
Foods 9798 21 CFR 106.100(c)
Foods 9917 21 CFR 120.10(c)
Foods 9953 21 CFR 120.11(a)(1)(iv)(A)
Foods 9959 21 CFR 120.12(d)(1)
Foods 12702 21 CFR 129.37(a)
Foods 12703 21 CFR 129.80(a)
Foods 12704 21 CFR 129.80(a)
Foods 15001 21 CFR 113.60(a)
Foods 15351 FDCA 761(b)(1)
Foods 15352 FDCA 761(b)(1)
Foods 15380 21 CFR 111.8
Foods 15381 21 CFR 111.8

Foods 15389 21 CFR 111.10(b)(1)
Foods 15390 21 CFR 111.10(b)(2)
Foods 15391 21 CFR 111.10(b)(3)
Foods 15392 21 CFR 111.10(b)(4)
Foods 15397 21 CFR 111.10(b)(7)
Foods 15398 21 CFR 111.10(b)(8)
Foods 15403 21 CFR 111.12(b)
Foods 15411 21 CFR 111.14(b)(2)
Foods 15428 21 CFR 111.15(h)
Foods 15431 21 CFR 111.15(e)(1)
Foods 15432 21 CFR 111.15(e)(2)
Foods 15435 21 CFR 111.15(d)(3)
Foods 15445 21 CFR 111.15(c)(1)
Foods 15456 21 CFR 111.20(b)
Foods 15460 21 CFR 111.20(d)(1)(ii)
Foods 15462 21 CFR 111.20(d)(1)(iv)
Foods 15466 21 CFR 111.20(c)

Foods 15473 21 CFR 111.20(c)(7)
Foods 15475 21 CFR 111.20(e)(1)
Foods 15478 21 CFR 111.20(f)
Foods 15486 21 CFR 111.23(a)
Foods 15506 21 CFR 111.27(a)(4)
Foods 15507 21 CFR 111.27(a)(5)(i)
Foods 15523 21 CFR 111.27(d)(7)
Foods 15527 21 CFR 111.30(c)
Foods 15528 21 CFR 111.30(d)
Foods 15535 21 CFR 111.255(d)
Foods 15540 21 CFR 111.260(a)(2)(i)
Foods 15553 21 CFR 111.260(j)(2)(i)
Foods 15555 21 CFR 111.260(j)(2)(iii)
Foods 15561 21 CFR 111.260(k)(3)
Foods 15563 21 CFR 111.260(l)(1)(i)
Foods 15568 21 CFR 111.260(m)
Foods 15571 21 CFR 111.153
Foods 15575 21 CFR 111.153

Foods 15576 21 CFR 111.155(a)
Foods 15581 21 CFR 111.155(c)(3)
Foods 15582 21 CFR 111.155(e)
Foods 15597 21 CFR 111.160(c)(3)
Foods 15600 21 CFR 111.160(d)(2)
Foods 15602 21 CFR 111.160(e)
Foods 15603 21 CFR 111.165(a)
Foods 15604 21 CFR 111.165(b)
Foods 15605 21 CFR 111.165
Foods 15609 21 CFR 111.165(c)(3)
Foods 15610 21 CFR 111.165(d)(1)
Foods 15611 21 CFR 111.165(d)(2)
Foods 15615 21 CFR 111.180(a)
Foods 15618 21 CFR 111.180(b)(1)
Foods 15625 21 CFR 111.180(b)(3)
Foods 15632 21 CFR 111.180(b)(3)(ii)(B)
Foods 15649 21 CFR 111.465(a)(1)
Foods 15653 21 CFR 111.470

Foods 15689 21 CFR 111.315(b)(3)
Foods 15708 21 CFR 111.325(a)
Foods 15709 21 CFR 111.325(b)(2)
Foods 15712 21 CFR 111.325(b)(2)(ii)
Foods 15721 21 CFR 111.365(k)
Foods 15722 21 CFR 111.365(j)
Foods 15725 21 CFR 111.365(g)
Foods 15726 21 CFR 111.365(f)
Foods 15727 21 CFR 111.365(e)
Foods 15735 21 CFR 111.355
Foods 15753 21 CFR 111.210(b)
Foods 15755 21 CFR 111.205(c)
Foods 15756 21 CFR 111.205(c)
Foods 15758 21 CFR 111.205(c)
Foods 15765 21 CFR 111.430(a)
Foods 15767 21 CFR 111.425
Foods 15770 21 CFR 111.420(a)
Foods 15771 21 CFR 111.415(h)
Foods 15776 21 CFR 111.415(d)

Foods 15778 21 CFR 111.415(b)
Foods 15780 21 CFR 111.415
Foods 15781 21 CFR 111.415
Foods 15802 21 CFR 111.560(c)
Foods 15813 21 CFR 111.570(b)(2)(ii)(B)
Foods 15821 21 CFR 111.60(a)
Foods 15826 21 CFR 111.65
Foods 15833 21 CFR 111.70(c)(1)
Foods 15836 21 CFR 111.70(c)(3)
Foods 15847 21 CFR 111.73
Foods 15848 21 CFR 111.73
Foods 15849 21 CFR 111.73
Foods 15854 21 CFR 111.73
Foods 15863 21 CFR 111.75(a)(2)(ii)(B)
Foods 15868 21 CFR 111.75(b)(2)
Foods 15874 21 CFR 111.75(c)(4)
Foods 15875 21 CFR 111.75(d)(1)

Foods 15876 21 CFR 111.75(d)(2)
Foods 15881 21 CFR 111.75(g)
Foods 15890 21 CFR 111.80(a)
Foods 15901 21 CFR 111.83(b)(3)
Foods 15905 21 CFR 111.90(a)(1)
Foods 15924 21 CFR 111.95(b)(5)
Foods 15933 21 CFR 111.105(b)
Foods 15934 21 CFR 111.105(c)
Foods 15935 21 CFR 111.105(d)
Foods 15938 21 CFR 111.105(f)
Foods 15943 21 CFR 111.105(i)
Foods 15946 21 CFR 111.105(i)
Foods 15948 21 CFR 111.110
Foods 15958 21 CFR 111.113(a)(5)
Foods 15960 21 CFR 111.113(b)(1)
Foods 15966 21 CFR 111.117(a)
Foods 15968 21 CFR 111.117(c)

Foods 15969 21 CFR 111.117(d)
Foods 15970 21 CFR 111.120
Foods 15978 21 CFR 111.123(a)(2)
Foods 15980 21 CFR 111.123(a)(4)
Foods 15981 21 CFR 111.123(a)(5)
Foods 15985 21 CFR 111.123(b)(1)
Foods 15987 21 CFR 111.123(b)(3)
Foods 15988 21 CFR 111.123(b)(4)
Foods 16006 21 CFR 111.130(d)
Foods 16008 21 CFR 111.135
Foods 16010 21 CFR 111.140(a)
Foods 16011 21 CFR 111.140(a)
Foods 16017 21 CFR 111.140(b)(3)
Foods 16043 21 CFR 111.503
Foods 16051 21 CFR 111.525(b)
Foods 16061 21 CFR 111.35(a)
Foods 16069 21 CFR 111.35(b)(1)(iii)

Foods 16074 21 CFR 111.35(b)(4)
Foods 16077 21 CFR 111.35(b)(5)
Foods 16119 21 CFR 118.4(a)(1)
Foods 16150 21 CFR 118.4(e)
Foods 16153 21 CFR 118.5(a)(1)
Foods 16168 21 CFR 118.6(f)
Foods 16171 21 CFR 118.7(a)
Foods 16184 21 CFR 118.9
Foods 16185 21 CFR 118.9
Foods 16197 21 CFR 118.10(a)(3)(vi)

Foods 16200 21 CFR 118.10(d)
Foods 16209 21 CFR 118.11(a)
Foods 17004 FDCA 402(a)

Short Description
Lack of effective pest exclusion
Sanitation monitoring
Screening
HACCP plan implementation
Food safety hazards
Floors, walls and ceilings
Critical control points
No HACCP plan
Buildings/sanitary
Sanitation Records
Critical limits
Corrective action plan
Running water at suitable temperature
Manufacturing conditions
Monitoring - adequacy
Harborage areas
Cleaning and sanitizing operations
Equipment, containers, utensils
Reasonable precautions
Buildings/good repair
As source of contamination
Safety lighting and glass
Storage
Not washed/sanitized when appropriate
Signed and dated
Failure to wear
Failure to clean - general
Materials and workmanship
Verification - record review - frequency
Records - content
Importer verification
Storage requirements
Component - verify identity, dietary ingredient

Maintenance of equip., utensils, and finished food
packaging
Drip and condensate
Seams on food contact surfaces
Verification procedures - adequacy
Written procedures - product complaint
Specifications met - verify; finished batch
Storage/transportation of finished goods

(contamination)
HACCP training or qualification
Precautions against contamination--micro, foreign

substances
Specifications - identity, purity, strength, composition
Suitable locations
Component - qualify supplier
Sufficient space
Master manufacturing record - each batch
Calibration - adequacy
Signs
Written procedures - holding; distributing
Written procedures - quality control operations
Hazard analysis
Batch record - complete
Suitable outer garments
Backflow prevention
Corrective action per predetermined plan
Personal food/drink/tobacco
Q.C. instrument accuracy, maintenance
Work-in-progress
Hand cleaning and sanitizing preparations
Metal / extraneous materials
Process filing
Sanitation monitoring documentation
Shown to be effective
Written procedures - holding
Effective use of hair restraint
Hand drying
Unsecured jewelry
Specifications-component purity, strength, composition
Written procedures - product complaint; review,

investigate
Storage of personal items
Precluding contaminants
Glove condition
Fans/air blowing equipment
Adequate lighting
Written procedures - returned dietary supplement
Sanitation monitoring
Verification procedures - none/frequency
Specifications - component identity

Records - returned dietary supplement: written
procedures
Non food-contact equipment in processing area
Reserve sample - collect, hold
Contamination with microorganisms, chemicals, filth,

etc.
Filling, assembling, packing controls
Scheduled process
Batch record - every batch
Maintenance of processing and production records
Self-closing doors
Master manufacturing record - unique formulation
HACCP plan location

Code - required elements
Maintained
Odor, attractant for pests, harborage
Safe and adequate for use
Registration
Lack of thermometer
Suitable temp. and pressure
Verification - recordkeeping
Training of handlers and supervisors
Records system
Scheduled process establishment
Monitoring record review adequacy
Records - packaging, labeling operations
Drainage
Testing
Records entries - timing
Spacing of equipment
Safe and adequate for use
Holding foods - refrigerate/freeze/heat
Packaging description, representative label

Specifications - manufacturing process
Personnel
Raw materials, packaging, finished product
Approved school
Records values/observations
SSOP records
Specifications - labels, packaging
Records - quality control operations; responsibilities
Written SE plan not implemented/followed
Hand jewelry - remove/cover
Insecticides/rodenticides
Ongoing verification - complaints, calibration records
Written procedures - labeling operations

Written SE plan lacks required elements
Date and time of activity
Reassessment of HACCP plan
Drainage
Container testing
HACCP plan not implemented
Personnel - quality control operations

Verification - reviewers qualifications
Holding, conveying, mfg systems - design &

construction
Convey sewage
Holding in bulk or suitable containers
Teardown equipment/thorough cleaning
Quality control procedures
Process adherence
Recall procedures
Verification activities - minimum
HACCP plan - food hazards not listed
HACCP plan - critical control points not listed
Personnel - records - training
Written procedures - cleaning
Procedures - calibrating instruments
Manufacturing operations - written procedures
Stray animals
Record retention
Food-contact - withstand food & cleaning cmpds.
Food-contact - unlawful indirect additives

Initial temperature
Good repair
Refuse receptacles
Coding - required elements
Process filing
Procedures - equipment - cleaning, sanitizing
Batch record - date, time; maintenance
Master manufacturing record - sampling, tests,

examinations
Appropriate tests, examinations; certificate of analysis
Personal cleanliness
Proper pH controls
Contamination by raw materials, refuse, other

ingredients
Storage/transportation of finished goods (deterioration)
HACCP plan - corrective action plan not included
Records - not signed and dated by qualified individual
Personnel - quality control personnel - qualified
Personnel - education, training, experience
Specifications - contamination limits

Specifications met - identity, purity, strength,
composition
Ensure quality; package, labeled, master record
Name and location
Signatures or initials on operational records
Corrective action documentation
pH testing
Devices and fixtures
Lack of records
HACCP plan - critical limits not listed or not adequate
HACCP plan - verify procedures / frequency - none

listed
Equipment - design - suitable
Equipment - automated - calibrate, inspect
Hold - temperature, humidity, light
Master manufacturing record theoretical and expected

yield
Master manufacturing record - specifications; quality
Quality control - quality, dietary supplement
Specifications - finished packaging, labeling

Specifications met - test, examinations; compliance
Documentation - supplier qualification
Processes, specifications, written procedures
Records - available; FDA
Records - ret'nd dietary supplement: material review,

dispos
Critical factors not stated
Review not done/timely
Preventive control measures
Conveyor transportation
Supervision
HACCP plan - location and type of juice
Verification - CCP, CA record review
Records - signed/dated
Instruments - calibration
Equipment - maintain, clean, sanitize
Instructions; specifications; quality
Product complaint - quality control investigate

Specifications met identity,purity, strength, comp,; basis
Tests, examinations - scientifically valid
Quality control operations - packaging, labeling

Document-equipment date of use, maintain, clean,
sanitize
Monitoring for flies
Food-contact - corrosion resistant
Hazard analysis - written - elements
Process controls - HACCP plan - 5 log reduction
Hand-washing facilities
Physical plant - repair
Batch record - component; unique identifier
Batch record - label
Hold - mix-up, contamination, deterioration
Corrective action plans
Packaging, labels - master manufacturing record
Production, process controls - implement
In-process identity, purity, strength, composition
Quality control - batch, product specifications

Reportable food report - submission
Cross contamination from people
Monitoring for rodents
Verification - corrective action
Modification HACCP plan
Bottling room separation
Single-service articles
Before use and after interruption
Safe and adequate sanitary quality
Record keeping requirements
Bacteriological
Receipt/storage - liquid and dry raw materials
Processing and production - required information
Readily accessible
Process deviation identification
Process adherence
Monitoring - none
Corrective action per regulation
No HACCP plan
HACCP plan - not validated
Records required - not maintained
Pest control measures
Physical plant - clean and sanitary

Written procedures - pest control
Batch record - yield
Batch record - identifier; labels
Written procedures - components
Components - identify lot received
Standard reference materials; criteria for selecting
Written procedures -packaging operations
Specifications - contamination limits
Specifications - product received for packaging, labeling
Specifications not met - reject, quality control
Written procedure quality control operations material

review
Pullet environment testing
Removal of pest harborages
Testing when laying hens 40 to 45 weeks
Method to be used, environmental samples
Refrigeration requirements documentation
Insufficient number of Q.C. instruments
Employees with illness, lesions, contamination source
Waste disposal
Sampling for micro contaminants
Adequate ventilation
Unacceptable toxic compounds
Chemical, physical, radiological
Inspection, segregation, handling of raw materials
Process deviations- identification and records
Cross contamination
Critical factors - entry missing information

Maintenance of grounds
Process change - increase
Approved school
Records - general - include name, date, time
No hazard analysis
Physical plant - screening against pests
Equipment - protect from contamination
Batch record - follow master
Batch record - approved, released, rejected; batch
Manufacturing operations - prevent contamination
Manufacturing operations - sanitation
Master manufacturing record - controls, procedures
Corrective action plan
Reserve sample -container-closure system
Egg transport temperature/time
Signature and date on SE plans
Determination of compliance
Operators
Supervisors
Scheduled processes not established
Process deviation log/file
Review not signed/dated
Supervisory competence
Batters, breading, gravies, sauces, etc.
Reject and rework
Conform to requirements
Visible code
Product distribution
Water quality -- wash, rinse, convey food
Inspection of containers and carriers upon receipt
Food contact - non-toxic materials
Registration
Verification - record review - calibration
Corrective action - predetermined plan inadequate
Sanitation SSOP - none or not implemented

HACCP plan - monitoring procedures not adequate
HACCP plan - recordkeeping system
Written procedures - personnel qualifications
Equipment - procedures
Equipment - automated - suitability
Batch record - date, time; maintenance
Components - quarantine
Packaging - identify
Records - receiving; components, packaging, labels,

products
Examination, testing; scientifically valid
Records - manufacturing operations; written

procedures
Metal, foreign material
Components; add, verify
Master manufacturing record - Supplemental Facts
Master manufacturing record-specifications; packaged,

label
Batch-lot,control number packaged, labeled dietary

supplemen
Labels - issuance, use
Record - product complaint; good manufacturing
practice
Component - confirm identity; specifications met
Specifications met, in-process - quality finished batch
Specifications - representative samples; finished batch
Reserve sample - twice the quantity
Records - established specifications

QC master manufacturing record; material review,
disposition
QC operations - master manufacturing record,
modifications
QC ops; written procedures; material review,

disposition
Records - keep: 1 year, 2 years
Returned dietary supplement - material review,

disposition
Documentation - instruments, controls; calibrations
Limiting visitors
Official review
Sampling of product & ops water
Containers kept sanitary
Suitability - equipment and utensils
Guard/guide dogs
Low-moisture food requirements
Contamination of food, contact surfaces, water

supplies, etc
General inadequacy
Thermometer calibration
Corresponding with MIG
Process deviation
Process information availability
All hazards not considered
Records - actual values
Corrective action - predetermined plan
Personnel - hygienic practices
Cleaning compounds and toxic materials - holding
Plumbing - backflow, cross connection
Floors, walls, ceilings
Records - cleaning, pest control
Refrigerator, freezer - alarm
Batch record - results; monitoring
Batch record - manufacture
Batch record - initials; verifying component
Batch record - identifier; packaging

Batch record - quality control review; production
Labels - identify
Written procedures - laboratory operations
Laboratory control processes - requirements
Examination, testing; appropriate
Instructions; components; weight, measure
Master manufacturing record - specific actions; quality
Manufacturing history
Product complaint - quality control review
Specifications identity, purity strength, composition
Specifications - product received for packaging, labeling
Specifications met - received product identified
Documentation - qualify supplier
Re-confirm certificate of analysis
Specifications met - verify; production, process control
QC operations -specifications; components, packaging,

labels
Quality control operations - quarantine

Quality control - finished batch, distribution
Plan appropriate to layout
Biosecurity measures documentation
Process adequacy records
Timing devices
Processing entry missing information
Suitability - contact surfaces
Evaluation by process authority
Incomplete information
No MIG thermometer
Aflatoxin and other natural toxins
Safety assurance - pests/extraneous materials
Multiservice primary containers
Testing of cleaning/sanitizing solutions
Thawed appropriately
Proper disposal of adulterated product
Critical factors
Process deviation evaluation - record

Record of visual closure examination
Closures other than double seams and glass
Temperature and humidity
Process information availability
Calibration record review adequacy
Importer - written procedures
Records - information not entered when observed
Process controls - not exempt, single facility
Records of cleaning/sanitizing solutions
HACCP plan - monitoring procedures - none listed
Hair restraints
Supervisor - qualified
Personnel - records - written procedures
Animals and pests in facility
Physical plant - separate areas for products
Procedures - calibrating automated, mechanical equip
Equipment - automated - design, selection
Packaging, labels - quarantine

Written procedures - packaging, labeling received
Written procedures - product received
Hold - reserve sample; closure system
Retain reserve samples - 1 year, 2 years

Records - product distribution
Written procedures - tests, examinations; specifications
met
Sampling plans; establish, follow
Sampling plans; components
Conditions, controls -protect; microorganisms,

contamination
Components, verify weight, measure
Representative sample - packaged, labeled dietary

supplement
Quality control, review, approve; investigate, follow-up
Record - product complaint; findings
Production, process controls - packaged, labeled
Specifications met - quality
Components packaging, labels received
Material review, disposition - quality control
Reprocessed, dietary supplement - no material review
QC - required operations master manufacturing/batch

records
QC - required operations packaging/labeling operations
QC production, process control; material review,

disposition
Quality control - adulteration; material review,

disposition
Document - material review, disposition
Quality control operations - equipment, instruments,

control
Quality control operations - finished batch,
specifications
QC operations - packaged, labeled; specifications
Records - original, true copies

Written procedures returned dietary supplement;
reprocessing
Equipment, utensils; maintaining, cleaning, sanitizing
No written SE prevention plan
Cross contamination from equipment
Satisfactory fly control methods
Pullets records documentation
Rodent and pest control documentation
Depopulation cleaning and disinfection procedures
Process controls
Records, English
Compressed air/gases
Sewage disposal
Coding - visible
Non-sealed system
Placement of washing/sanitizing ops
Processing entries not done/not timely
Maintaining sample & analysis records
Sanitization practices
Operating processes not posted
No corrective action taken
Sufficient quantities of water
MIG thermometer not used as reference
Water activity controls
Presence and accuracy
Location - from ends
Records of mechanical washers
Sanitizing operations inadequate
Two year requirement
Unauthorized adjustment
Representative samples
Inspection of filled containers
Washing and cleaning
Identify rework
Minimum headspace
Sufficient frequency
pH control
Thermal processing
Code - packing period
Process deviation evaluation
Wet cleaning
Doors opening into processing areas
Visual
Recording of teardown examinations
Coding - failure to mark
IT of cans in water filled retorts

Commercial production variations
Sanitation corrections
Validation - reviewer's qualifications
Calibration, testing - record review timeliness
Records - review and copying
HACCP plan - valid procedures / frequency - none listed
Calibration, testing - no records
Records - computerized
Importer - implementation of affirmative steps
Gloves
Trash disposal
Sanitation supervisors - assigned
Grounds - equipment, litter, weeds
Plumbing - source of contamination
Physical plant - material review and disposition
Equipment - installed to facilitate cleaning
Equipment - maintain - general
Equipment - controls, intended use

Batch record - component; identity, weight
Batch record - results; testing, examination; batch
Batch record - initials; each step
Batch record - initials; verifying weight
Batch record - packaging, labeling
Batch record - quality control; tests, examinations
Batch record - approved, released, rejected
Batch record - reprocessing
Written procedures - labels
Written procedures - product received; packaging,

labeling
Components - representative samples
Components - unique identifier
Components - contamination, deterioration, mix-ups
Product received - quarantine; representative samples
Product received - quality control; documentation;

specs
Documentation - packaging
Hold, identify - in-process material
Chemical,microbiological,other test-contaminated
components
Instructions; specifications; packaged, labeled
Master manufacturing record - intentional overage

Master manufacturing record - ingredients list
Master manufacturing record - components; weight,

measure
Master manufacturing record - dietary ingredients
Repackaged, relabeled - quality control: approve,

rejects
Repackaged, relabeled - specifications
Clean, sanitize - filling, packaging equipment
Label, packaging - discrepancies
Packaging - specifications
Product complaint -investigate, findings, follow-up
Specifications met in-process purity, strength,

composition
Product - visually examine, identified
Specifications not met - identity; component, reject
Specifications - representative samples; in-process

material
Specifications - representative samples; unique lot
Quality control - production, process control
Quality control operations - tests, examinations
Quality control operations - tests, examinations; results
Quality control - reject; specification not met

QC operations - material review, disposition decision
Quality control operations - master, batch,

manufacturing
Quality control operations - labeling; relabeling
Quality control operations - returned dietary

supplement
QC returned dietary supplement; material review,
disposition
Returned dietary supplement; salvage, redistribution
Material review, disposition, follow-up; investigation
Procedures - equipment; calibrating, inspecting,

checking
Documentation - equipment functions; intended use
QC supplier product released assurance not provided

package
Transfer or introduction of SE
Employees keeping birds at home
Supervisor(s) training/job experience
Records retention time
Written SE prevention plan
Sampling procedures documentation
24 hour retrieval of offsite records
Data and information re: compliance activities
Computerized records
Container closure inspectors
Lack of instruction/reporting of health conditions
Approved sources
Roads/yards/parking lots
Critical Factors
Distribution record
Record retention
Aseptic processing
Compliance with standards
Lockers and lunchrooms
Inspection for sanitary condition
Transport and storage
Exam, handling of single service containers et. al.
Scientific methods not performed
Vent not posted

System not established
Water activity
Other systems
RTC identification
Continuous operations
Entries not signed
Records review infrequent / not done
Unreadable MIG thermometer
Pasteurization or other adequate treatment
Mechanical manufacturing control
Range
Well bleeder
Observable
Samples and analyses
Installation
Short vent
Measured, recorded
Can positioning
Steam controller
No MIG thermometer
Scale and range
Defective thermometer
Not used as reference
Range
Scale
Operator check and recording
Package identification
Plant records
Inspection of containers and closures
Unauthorized changes
Kept frozen prior to use
Proper reconditioning
Unreadable thermometer
Calibration
Range
Calibration
Unauthorized speed changes

Heated or inadequate slope
Readings at start of aseptic processing
Readings with sufficient frequency
Methods and controls operated and administered for

safety
Inadequate instruments
Automatic recording devices
Process deviation - disposition
Neighboring grounds
Ice manufacturing
Method of taking seam measurements (micrometer)
Records of closure examinations other than cans or

glass
Methods of process deviation evaluation
Regular observations for gross closure defects
Venting, other installations

Records of process establishment
Reporting to FDA
Record retention
Notify FDA - spoilage
Notify FDA - contamination
Recall procedures
Process change reporting to CFSAN
Nutrient premix testing
Corrective action documentation
CCP record review adequacy
Record retention - general
Remedy unsanitary condition
Product samples
Analytical frequency
Corrective actions
No AE report made (dietary supplement)
No label copy submitted with AE report (dietary

supplement)
Written procedures - sick or infected personnel
Written procedures - hygienic practices

Outer garments
Personnel cleanliness
Hand washing
Jewelry and objects - remove
Personal belongings
Food, gum, beverages, tobacco
Personnel - quality control operations; responsibilities
Personnel - records - training date, type, persons
Bathrooms - clean
Water supply - not component - suitability
Water supply - may be component - suitability
Insecticides, fungicides
Sanitizing agents
Physical plant - space; equipment, materials
Physical plant - fixture
Physical plant - temperature, humidity controls
Physical plant - prevent mix-ups, contamination

Physical plant - separate areas - holding
Adequate light - processing, holding
Physical plant - bulbs, fixtures, skylights
Records - physical plant - available
Equipment - bonded seams
Refrigerator, freezer - temperature recording device
Utensils - store
Equipment - automated - QC check
Equipment - automated - controls, process changes
Batch record - 1 year, 2 years
Batch record - control number, each lot
Batch record - initials; weighing
Batch record - initials; component
Batch record - tests, examinations; results
Batch record - quality control review; monitoring
Batch record - performance
Written procedures - packaging
Written procedures - rejected products

Visually examine - containers
Quality control - components, approve, release
Components - contamination, deterioration, mix-ups
Labels - quality control; approve, release
Packaging, labels - unique identifier, disposition
Packaging, labels - mix-ups
Received product - visually examine container
Product received - visually examine invoice, guarantee,

cert
Product received - quarantine
Product received - quality control; quarantine; release
Product received - identify
Product received - unique identifier, disposition
Records - components, packaging, labels, product

received:
Written procedures - components
Documentation - components
Documentation - required operation; initials
Hold - reserve samples; ordinary storage
Distribute dietary supplement; contamination,

deterioration
Sampling plans; finished batches
Written procedures, laboratory operations
Laboratory methodology followed
Records - document; results
Processing lines, major equipment - contents
Containers - segregating, identifying
Identifying, holding - contamination, mix-ups
Holding - prevent becoming adulterated
Microorganism, decomposition - remove, destroy,

prevent
Manufacturing operations - design
Master manufacturing record - list components
Master manufacturing record: readily available
Master manufacturing record: electronic
Master manufacturing record: 1 year, 2 years
Packaging, labeling operations:originals, copies,

electronic
Quarantine - rejected packaged, labeled dietary

supplement
Repackaging, relabeling - quality control, approve
Obsolete labels, packaging - dispose
Packaging, labeling - physical separation

Dietary supplement - protect, contamination
Fill, assemble, package, label - master record
Fill, assemble, package, label - quality
Product complaint - review, investigation
Record - product complaint; batch, lot, control number
Production, in- process control system - design, quality
Quality control - packaged, labeled
Specifications - in-process contamination limits
QC specification, identity, purity, strength, composition
Specifications met - component identity
Specifications met - component purity, strength,

composition
Specifications met - contamination limits
Specifications met - contamination limits
Component - certificate of analysis
Specifications met - deviation, unanticipated

occurrence
Documentation - specifications met; basis, quality

control
Documentation specifications met; exempted, periodic

testing
Exempted, periodic testing; quality control
Packaging, labeling - visual examination
Components packaging, labels used
Reserve sample - retained
Reprocessed - rejected dietary supplement
Documentation - exempted product specification met
Quality control - supplier qualification
Basis; in-process, component, specifications
Quality control - basis; tests, examinations
Quality control - representative samples
QC required operations components packaging labels
QC - required operations returned dietary supplements
Quality control operations - laboratory operations
QC returned dietary supplement; material review,

disposition
Quality control - dietary supplement; adulteration
Quality control operations - calibrating processes
Quality control operations - equipment records

Quality control operations - equipment functions
Quality control operations - components, packaging,

labels
Quality control operations - batch production records
QC operations - material review, disposition decision
Quality control operations - reprocessing
Quality control - components, identity specifications
Quality control - batch released, adulteration
QC supplier; product released, assurance not provided

label
QC operations - returned dietary supplement;

specifications
Quality control operations - product complaints;

investigate
Records - QC operations: originals, copies, electronic
Records - quality control operations: electronic
Records - material review, disposition
Written procedures - returned dietary supplement;

destroyed
Returned dietary supplement - release
Records - equipment, utensils: 1 year, 2 years
Procedures contact surfaces; maintaining, cleaning,

sanitize
Records - equipment; calibrations, inspections, checks
Records - backup files, outdated software
Procurement of chicks
Eggs to be processed as table eggs
Poultry house has multiple groups of laying hens
Labeling on diverted eggs
Environmental test
Lack of supervisory personnel
Supervisor duties
SE testing results documentation

Offsite storage of records except SE plan
Registration within 30 days
Food Field Exam

Long Description
Effective measures are not being taken to [exclude pests from the processing areas] [protect against the
contamination of food on the premises by pests]. Specifically, ***
You are not monitoring the sanitation conditions and practices with sufficient frequency to assure
conformance with Current Good Manufacturing Practices including [safety of water that comes into
contact with food or food contact surfaces, including water used to manufacture ice] [condition and
cleanliness of food contact surfaces] [prevention of cross-contamination from insanitary objects]
[maintenance of hand washing, hand sanitizing, and toilet facilities] [protection of food, food packaging
material, and food contact surfaces from adulteration] [proper labeling, storage and use of toxic
chemicals] [control of employee health conditions] [exclusion of pests]. Specifically, ***
Failure to provide adequate screening or other protection against pests. Specifically, ***
You did not implement the [monitoring] [recordkeeping] [verification] procedures listed in your HACCP
plan. Specifically, ***
Your HACCP plan does not list the food safety hazards that are reasonably likely to occur. Specifically, ***
The plant is not constructed in such a manner as to allow [floors] [walls] [ceilings] to be [adequately
cleaned and kept clean] [kept in good repair]. Specifically, ***
Your HACCP plan does not list one or more critical control points that are necessary for each of the
identified food safety hazards. Specifically, ***
You do not have a written HACCP plan that outlines controls for a food safety hazard that is reasonably
likely to occur. Specifically, ***
Failure to maintain buildings, fixtures, or other physical facilities in a sanitary condition. Specifically, ***
You are not maintaining sanitation control records that document [monitoring] [corrections of sanitation
deficiencies] for [safety of water that comes into contact with food or food contact surfaces, including
water used to manufacture ice] [condition and cleanliness of food contact surfaces] [prevention of cross-
contamination from insanitary objects] [maintenance of hand washing, hand sanitizing, and toilet
facilities] [protection of food, food packaging material, and food contact surfaces from adulteration]
[proper labeling, storage and use of toxic chemicals] [control of employee health conditions] [exclusion of
pests]. Specifically, ***
Your HACCP plan [does not list a critical limit that ensures control of one or more hazards] [lists a critical
limit that does not ensure control of one or more hazards]. Specifically,
Your HACCP plan includes a corrective action plan that is not in accordance with 21 CFR 123.7(b) to
ensure [affected product is not entered into commerce] [the cause of the deviation was corrected].
Specifically***
Hand-washing facilities lack running water of a suitable temperature. Specifically, ***
Failure to [manufacture] [package] [store] foods under conditions and controls necessary to minimize
[the potential for growth of microorganisms] [contamination]. Specifically, ***
Your HACCP plan lists monitoring [procedures] [frequencies] that do not ensure compliance with the
critical limit. Specifically***
Failure to [properly store equipment] [remove litter and waste] [cut weeds or grass] that may constitute
an attractant, breeding place, or harborage area for pests, within the immediate vicinity of the plant
buildings or structures. Specifically, ***
Failure to conduct cleaning and sanitizing operations for utensils and equipment in a manner that
protects against contamination of [food] [food-contact surfaces] [food-packaging materials]. Specifically,
***
Failure to [construct] [handle] [maintain] equipment, containers and utensils used to [convey] [hold]
[store] food in a manner that protects against contamination. Specifically, ***
All reasonable precautions are not taken to ensure that production procedures do not contribute
contamination from any source. Specifically, ***
Failure to maintain [buildings] [fixtures] [physical facilities] in repair sufficient to prevent food from
becoming adulterated. Specifically, ***
Plumbing constitutes a source of contamination to [food] [water supplies] [equipment] [utensils].
Specifically, ***
Failure to provide safety-type [light bulbs] [lighting fixtures] [skylights] [glass] suspended over exposed
food. Specifically, ***
Failure to store raw materials in a manner that [protects against contamination] [minimizes
deterioration]. Specifically, ***
Employees did not [wash] [sanitize] hands thoroughly in an adequate hand-washing facility [before
starting work] [after each absence from the work station] [at any time their hands may have become
soiled or contaminated]. Specifically, ***
Your HACCP plan was not signed and dated [upon initial acceptance] [upon modification] [at least
annually]. Specifically, ***
Failure to wear [hair nets] [head bands] [caps] [beard covers] [hair restraints] where appropriate.
Specifically, ***
Failure to clean [food-contact surfaces] [utensils] as frequently as necessary to protect against
contamination of food. Specifically, ***
The [design] [materials] [workmanship] of [equipment] [utensils] does not allow proper [cleaning]
[maintenance]. Specifically, ***
You did not review [some of] your [critical control point monitoring][corrective action][calibration][in-
process testing][end-product testing] records [within one week][within a reasonable time] after the
records were made. Specifically, ***
Your records do not include the [name and location of the processor or importer] [date and time of the
activity the record reflects] [signature or initials of the person performing the operation] [identity of the
product and the production code, if any]. Specifically, ***
You do not have or have not implemented [written verification procedures] [product specifications] [an
affirmative step] for ensuring that [fish] [fishery products] you import are processed in compliance with
the Seafood HACCP regulation. Specifically, ***
Failure to properly [identify] [hold] [store] toxic [cleaning compounds] [sanitizing agents] [pesticide
chemicals] in a manner that protects against contamination of [food] [food-contact surfaces] [food-
packaging materials]. Specifically, ***
You did not conduct at least one appropriate test or examination to verify the identity of a dietary
ingredient, prior to its use. Specifically, ***
Failure to maintain [equipment] [utensils] [finished food containers] in an acceptable condition through
appropriate cleaning and sanitizing. Specifically, ***
The plant is not constructed in such a manner as to prevent [drip] [condensate] from contaminating
[food] [food-contact surfaces] [food-packaging materials]. Specifically, ***
Failure to have smoothly bonded or well maintained seams on food contact surfaces, to minimize
accumulation of [food particles] [dirt] [organic matter] and the opportunity for growth of
microorganisms. Specifically, ***
Your HACCP plan lists verification [procedures] [frequencies] that have not been developed in accordance
with 21 CFR 123.8(a) to ensure that your HACCP plan is adequate to control food safety hazards, and is
being effectively implemented. Specifically, ***
You did not [establish] [follow] written procedures for the requirements to review and investigate a
product complaint. Specifically, ***
You did not verify that your finished batch of dietary supplement meets product specifications for
[identity] [purity] [strength] [composition] [limits on contamination that may adulterate or that may lead
to adulteration of the dietary supplement]. Specifically, ***
Failure to [store] [transport] finished food under conditions that would protect against [physical]
[chemical] [microbial] contamination. Specifically, ***
No one associated with your firm has completed the required HACCP training or is HACCP qualified
through job experience. Specifically, ***
Failure to take necessary precautions to protect against contamination of [food] [food contact surfaces]
[food packaging systems] with [microorganisms] [foreign substances]. Specifically, ***
You did not establish product specifications for the [identity] [purity] [strength] [composition] of the
finished dietary supplement. Specifically, ***
Failure to provide [hand washing] [hand sanitizing] facilities at each location in the plant where needed.
Specifically, ***
You did not qualify a supplier of a component by establishing the reliability of the supplier's certificate of
analysis through confirmation of the results of their tests or examinations. Specifically, ***
Failure to provide sufficient space for [placement of equipment] [storage of materials] as necessary for
the maintenance of sanitary operations and the production of safe food. Specifically, ***
You did not [prepare] [follow] a written master manufacturing record for each batch size of a dietary
supplement that you manufactured. Specifically, ***
Your process monitoring equipment is not calibrated to ensure that it reads accurately. Specifically, ***
Lack of posted, readily understandable signs directing employees to wash and sanitize hands as
appropriate. Specifically, ***
You did not make and keep written procedures for holding and distributing operations. Specifically, ***
You did not [establish] [follow] written procedures for quality control operations. Specifically, ***
You did not conduct, or have conducted for you, a hazard analysis to determine whether there are food
safety hazards that are reasonably likely to occur for each kind of fish and fishery product you process.
Specifically, ***
Your batch production record did not include complete information relating to the production and control
of each batch. Specifically, ***
Suitable outer garments are not worn that protect against contamination of [food] [food contact
surfaces] [food packaging materials]. Specifically, ***
Lack of backflow protection from piping systems that discharge [waste water] [sewage]. Specifically, ***
You did not take corrective action that ensured [affected product was not entered into commerce] [the
cause of the deviation was corrected]. Specifically,***
Employees were observed to be [eating food] [chewing gum] [drinking beverages] [using tobacco] in
areas where [food is exposed] [equipment or utensils are washed]. Specifically, ***
Instruments used for [measuring] [regulating] [recording] conditions that control or prevent the growth of
undesirable microorganisms are not [accurate] [adequately maintained]. Specifically,***
Failure to handle work-in-progress in a manner that protects against contamination. Specifically, ***
Lack of effective hand [cleaning] [sanitizing] preparations. Specifically, ***

Failure to take effective measures to protect against the inclusion of [metal] [extraneous material] in
food. Specifically, ***
Failure to provide the FDA, before packing any new product, information on the scheduled processes for
each acidified food in each container size. Specifically, ***
Your sanitation control records do not accurately document the conditions or practices observed at your
firm. Specifically***
The [facility] [procedure] [machine] used for [cleaning] [sanitizing] of [equipment] [utensils] has not been
shown to provide adequate [cleaning] [sanitizing treatment]. Specifically, ***
You did not [establish] [follow written] procedures for holding and distributing operations. Specifically,
***
Failure to wear [hair nets] [head bands] [caps] [beard covers] [appropriate hair restraints] in an effective
manner. Specifically, ***
Lack of a sanitary towel service or suitable hand drying devices. Specifically, ***
Employees failed to remove unsecured jewelry or other objects which might fall into [food] [equipment]
[containers]. Specifically, ***
You did not establish component specifications for [purity] [strength] [composition]. Specifically, ***
You did not make and keep written procedures to fulfill the requirements that apply to the review and
investigation of a product complaint. Specifically, ***
Personal [clothing] [belongings] were stored in an area where [food is exposed] [equipment or utensils
are washed]. Specifically, ***
The [design] [construction] [use] of equipment and utensils fails to preclude the adulteration of food with
[lubricants] [fuel] [metal fragments] [contaminated water] [contaminants]. Specifically, ***
Gloves used in food handling are not maintained in an intact, clean, and sanitary condition. Specifically,
***
Failure to [locate] [operate] fans and other air-blowing equipment in a manner that minimizes the
potential for contaminating [food] [food-contact surfaces] [food-packaging materials]. Specifically, ***
Failure to provide adequate lighting in [hand-washing areas] [dressing and locker rooms] [toilet rooms]
[areas where food is examined, stored, or processed] [areas where equipment and utensils are cleaned].
Specifically, ***
You did not [establish] [follow] written procedures for when a returned dietary supplement is received.
Specifically, ***
You are not monitoring the sanitation conditions and practices with sufficient frequency to assure
conformance with current good manufacturing practice including [safety of water that comes into contact
with food or food contact surfaces, including water used to manufacture ice] [condition and cleanliness of
food contact surfaces] [prevention of cross-contamination from insanitary objects] [maintenance of hand
washing, hand sanitizing, and toilet facilities] [protection of food, food packaging material, and food
contact surfaces from adulteration] [proper labeling, storage and use of toxic chemicals] [control of
employee health conditions] [exclusion of pests]. Specifically, ***
Your HACCP plan does not list verification [procedures] [frequencies] that have been developed to ensure
that the HACCP plan is adequate to control food safety hazards, and is being effectively implemented.
Specifically, ***
You did not establish an identity specification for each component. Specifically, ***
You did not make and keep records of written procedures for fulfilling requirements for returned dietary
supplements. Specifically, ***
Non food-contact equipment in [manufacturing] [food handling] areas is not constructed so that it can be
kept in a clean condition. Specifically, ***
You did not collect and hold reserve samples of packaged and labeled dietary supplements that you
distributed. Specifically, ***
Proper precautions to protect [food] [food-contact surfaces] [food-packaging materials] from
contamination with [microorganisms] [chemicals] [filth] [extraneous material] cannot be taken because of
deficiencies in plant [size] [construction] [design]. Specifically, ***
Failure to perform [filling] [assembling] [packaging] in a manner that protects food from becoming
contaminated. Specifically, ***
Acidified food is not manufactured in accordance with the scheduled process. Specifically, ***
You did not prepare a batch production record every time you manufactured a batch of dietary
supplement. Specifically, ***
Failure to maintain [processing] [production] records showing adherence to the scheduled processes,
including records of [pH measurement] [critical factors] intended to ensure a safe product. Specifically,
***
Toilet facilities lack self-closing doors. Specifically, ***
You did not [prepare] [follow] a written master manufacturing record for each unique formulation of a
dietary supplement that you manufactured. Specifically, ***
Your HACCP plan is not specific to [the location where the fish are processed] [the kind of fish or fishery
product processed]. Specifically, ***
Each container is not marked with an identifying code specifying the [establishment where the product
was packed] [product contained therein] [year] [date] [packing period]. Specifically, ***
Failure to maintain toilet facilities in a sanitary condition. Specifically, ***
The [conveyance] [storage] [disposal] of [rubbish] [offal] does not minimize the [development of odor]
[potential for waste becoming an attractant and harborage or breeding place for pests]. Specifically, ***
Use of cleaning compounds and sanitizing agents which are not [free from undesirable microorganisms]
[safe and adequate under the conditions of use]. Specifically, ***
Failure to register with the FDA information including the name, principal place of business and the
location of the processing establishment within 10 days after engaging in the manufacture, processing
and packaging of acidified foods. Specifically, ***
Lack of an accurate indicating thermometer, temperature measuring device, or temperature recording

device in each freezer and cold storage compartment used to store food capable of supporting the
growth of microorganisms. Specifically, ***
Failure to provide running water [at a suitable temperature] [under suitable pressure] for [processing of
food] [cleaning of equipment, utensils and food-packaging materials] [employee sanitary facilities].
Specifically, ***
You do not maintain records of [calibration of process-monitoring instruments] [periodic end-product or
in-process testing]. Specifically, ***
Appropriate training in food handling techniques and food protection principles has not been provided to
[food handlers] [supervisors]. Specifically, ***
Your HACCP plan does not provide for a recordkeeping system that documents the monitoring of the
critical control points. Specifically, ***
A scheduled process was not established by a qualified person who has expert knowledge acquired
through appropriate training and experience in acidification and processing of acidified foods.
Specifically, ***
Your review of critical control point monitoring records does not [ensure that the records are complete]
[verify that they document values that are within critical limits]. Specifically, ***
You did not make and keep records of the written procedures for [packaging] [labeling] operations.
Specifically, ***
Lack of adequate drainage of areas which may contribute to contamination of food by [seepage] [foot-
borne filth] [providing a breeding place for pests]. Specifically, ***
Failure to perform [chemical] [microbial] [extraneous material] testing where necessary to identify
[sanitation failures] [possible food contamination]. Specifically, ***
Processing or other information was not [always] entered on your records at the time it was observed.
Specifically, ***
Aisles or working spaces between equipment and walls are [obstructed] [of inadequate width].
Specifically, ***
Sanitizing agents are [inadequate] [unsafe] under conditions of use. Specifically, ***
Failure to hold foods which can support the rapid growth of undesirable microorganisms at a temperature
that prevents the food from becoming adulterated. Specifically, ***
Your master manufacturing record did not include a [description of the packaging] [a representative label,
or a cross-reference to the physical location of the actual or representative label]. Specifically,
You did not establish a specification for a point, step, or stage in the manufacturing process where control
is necessary to ensure [the quality of the dietary supplement] [that the dietary supplement is packaged
and labeled as specified in the master manufacturing record]. Specifically, ***
Operators of processing and packaging systems are not under the operating supervision of a person who
has attended and satisfactorily completed a school approved by the Commissioner. Specifically, ***
Records are not maintained of the examination of [raw materials] [packaging materials] [finished
products] [supplier's guarantees or certificates] to verify compliance with FDA regulations and guidelines
or action levels. Specifically, ***
Failure to have personnel involved in [acidification] [pH control] [heat treatment] [critical factors] under
the operating supervision of a person who has attended and satisfactorily completed a school approved
by the Commissioner. Specifically, ***
Your monitoring records do not contain the actual values and observations obtained during monitoring.
Specifically, ***
You do not [always] maintain sanitation standard operating procedure records that document [the
monitoring of conditions and practices during processing] [corrections to conditions and practices that
were not met]. Specifically, ***
You did not establish [label] [packaging] specifications. Specifically, ***
You did not make and keep written procedures for the responsibilities of the quality control operations.
Specifically, ***
Your written SE prevention plan is not [fully] implemented and followed. Specifically,***
Failure to [remove] [adequately cover] hand jewelry which cannot be adequately sanitized during periods
where food is being manipulated by hand. Specifically, ***
Use of [insecticides] [rodenticides] without observing necessary precautions and restrictions to protect
against contamination of [food] [food-contact surfaces] [food-packaging materials]. Specifically, ***
Your verification procedures do not include, at a minimum, ongoing verification activities including
[review of consumer complaints] [calibration of process monitoring instruments] [review of monitoring,
corrective action, and calibration records]. Specifically, ***
You did not [establish] [follow] written procedures for labeling operations. Specifically, ***
Your written SE prevention plan lacks appropriate SE prevention measures. Specifically,***
All your required records do not include the [date] [time] of the activity that the records reflect.
Specifically,***
Your verification procedures do not include, at a minimum, reassessment of the HACCP plan [at least
annually] [whenever modifications to the process are made]. Specifically, ***
Plumbing is not [of adequate size and design] [adequately installed and maintained] to provide adequate
floor drainage. Specifically, ***
Failure to [test] [examine] containers often enough to ensure that containers suitably protect the food
from leakage and contamination. Specifically, ***
You did not [fully] implement the [monitoring] [validation] [verification] [recordkeeping] procedures listed
in your HACCP plan. Specifically, ***
You have not identified personnel to be responsible for your quality control operations. Specifically, ***
The [reassessment of your HACCP plan] [monitoring, corrective action, or verification record review] was
not done by an individual who had successfully completed training in the application of HACCP principles
to fish and fishery product processing, or was otherwise qualified through job experience to perform
these functions. Specifically, ***
Lack of appropriate [design] [construction] to enable [holding] [conveying] [manufacturing] systems to be

maintained in an appropriate sanitary condition. Specifically, ***
Plumbing is not [of adequate size and design] [adequately installed and maintained] to properly convey
sewage and liquid disposable waste from the plant. Specifically, ***
Failure to hold [raw materials] [rework materials] [ingredients] in bulk or in suitable containers so as to
protect against contamination. Specifically, ***
Failure to take apart equipment as necessary to ensure thorough cleaning. Specifically, ***
Appropriate quality control procedures are not employed to ensure that finished foods do not present a
health hazard. Specifically, "***
Failure to process each food in conformity with at least the scheduled process filed with FDA. Specifically,
***
Failure to prepare and maintain in files current procedures for [recalling products that may be injurious to
health] [identifying, collecting, warehousing and controlling products] [determining the effectiveness of
recalls] [notifying FDA] [implementing recall programs]. Specifically, ***
Your verification activities do not include, at a minimum, [review of consumer complaints to determine
whether they relate to the performance of the HACCP plan] [calibration of process monitoring
instruments] [end-product or in-product testing] [review of critical control point monitoring, corrective
action, and calibration records] to ensure that your HACCP system is being properly implemented.
Specifically, ***
Your HACCP plan does not list all food hazards that are reasonably likely to occur. Specifically, ***
Your HACCP plan does not list the critical control points for each of the identified food hazards.
Specifically, ***
You did not make and keep documentation of training. Specifically, ***
You did not [establish] [follow] written procedures for cleaning the physical plant. Specifically, ***
You did not [establish] [follow] written procedures for calibrating instruments and controls that you use in
manufacturing or testing a component or dietary supplement. Specifically, ***
You did not [establish] [follow] written procedures for manufacturing operations. Specifically, ***
Stray animals are not prevented from entering poultry houses. Specifically,***
Your [monitoring] [corrective action] [verification] records are not maintained at your facility for at least
the required time period. Specifically, ***
Food contact surfaces are not designed to [withstand the environment of their intended use] [withstand
the action of food] [withstand cleaning compounds and sanitizing agents]. Specifically, ***
Failure to maintain food contact surfaces to protect food from contamination by any source, including
unlawful indirect food additives. Specifically, ***
The initial temperature of the contents of a container to be processed was [not determined] [not
recorded] with sufficient frequency to ensure the temperature was not lower than the minimum initial
temperature stated in the scheduled process. Specifically, ***
Failure to keep toilet facilities in good repair. Specifically, ***
Refuse receptacles for hand washing facilities are not [constructed] [maintained] to protect against
contamination of food. Specifically, ***
The required container identification fails to include the [establishment where packed] [product] [year
packed] [day packed] [period during which packed]. Specifically, ***
Failure to provide FDA, before packing any new product, information as to the scheduled process for each
low-acid canned food in each container. Specifically, ***
You did not [establish] [follow] written procedures for maintaining, cleaning, and sanitizing, equipment,
utensils, and any other contact surfaces that are used to manufacture, package, label, or hold
components or dietary supplements. Specifically, ***
Your batch production records did not include the date and time of the maintenance, cleaning, and
sanitizing of the equipment and processing lines used in producing the batch, or a cross-reference to
records, such as individual equipment logs, where this information is retained. Specifically, ***
The written instructions in your master manufacturing record did not include [procedures for sampling] [a
cross-reference to procedures for tests or examinations]. Specifically, ***
You did not conduct appropriate tests or examinations or rely on a certificate of analysis to determine
whether components met established specifications. Specifically, ***
Employees in contact with [food] [food-contact surfaces] [food-packaging materials] were not
maintaining adequate personal cleanliness. Specifically, ***
Failure to adequately [monitor pH] [maintain a pH of 4.6 or below] for foods that rely principally on the
control of pH to prevent the growth of undesirable microorganisms. Specifically, ***
Failure to take effective measures to protect finished food from contamination by [raw materials] [refuse]
[other ingredients] . Specifically, ***
Failure to [store] [transport] finished food under conditions that would protect against deterioration of
the food and its container. Specifically, ***
Your HACCP plan includes a corrective action plan that is not in accordance with 21 CFR 120.10(a) to
ensure [affected product is not entered into commerce] [the cause of the deviation was corrected].
Specifically,***
Your review of [critical control point monitoring records] [corrective action records] [calibration records]
[periodic end-product or in-process testing records] are not [performed] [signed] [dated] by an individual
who is trained in the application of HACCP principles to juice processing or otherwise qualified through
job experience. Specifically, ***
The personnel you identified to perform quality control operations [are not qualified to do so] [do not
have the education, training or experience to perform the assigned functions]. Specifically, ***
Personnel engaged in [manufacturing] [packaging] [labeling] [holding] dietary supplements do not have
the education, training, or experience to perform the person's assigned functions. Specifically, ***
You did not establish limits for contamination that may adulterate or may lead to adulteration of the
finished dietary supplement. Specifically, ***
You did not determine whether you met established product specifications for [identity] [purity]
[strength] [composition of the finished batch of the dietary supplement]. Specifically, ***
Your quality control personnel did not ensure that your [manufacturing] [packaging] [labeling] [holding]
operations ensure the quality of the dietary supplement. Specifically, ***
All required records do not include [your name] [the location of your farm]. Specifically,***
All required records do not have the signature or initials of the person performing the operation or
creating the record. Specifically,***
You do not have records that document corrective actions that were taken. Specifically, ***
Failure to exercise sufficient control including [frequent testing] [recording of results] so that the finished
equilibrium pH values are not higher than 4.6. Specifically, ***
Devices and fixtures are not designed and constructed to protect against recontamination of clean,
sanitized hands. Specifically, ***
You do not have records to document the performance and results of the affirmative steps taken to
demonstrate that [fish] [fishery products] imported into the United States were processed in accordance
with the seafood HACCP regulation. Specifically, ***
Your HACCP plan [does not list one or more of the critical limits that must be met at each critical control
point] [lists a critical limit that does not prevent, eliminate, or reduce to an acceptable level the
occurrence of an identified food hazard]. Specifically, ***
Your HACCP plan does not list the verification [procedures] [frequencies] that have been developed to
ensure that the HACCP plan is being implemented. Specifically, ***
You did not use equipment or utensils of appropriate design, construction, and workmanship to enable
them to be [suitable for its intended use] [adequately cleaned] [properly maintained]. Specifically, ***
You did not routinely [calibrate] [inspect] [check] the automated, mechanical, or electronic equipment to
ensure proper performance. Specifically, ***
You did not hold [components] [dietary supplements] under appropriate conditions of temperature,
humidity, or light so that their identity, purity, strength, and composition are not affected. Specifically,
***
Your master manufacturing record did not include a statement of [the theoretical yield for each point,
step, or stage of the manufacturing process to ensure quality control] [the expected yield of the finished
dietary supplement] [the maximum and minimum percentages of theoretical yield beyond which a
deviation investigation of a batch is necessary and material review is conducted and disposition decision
is made]. Specifically, ***
Your master manufacturing record did not identify specifications for the points, steps, or stages in the
manufacturing process where control is necessary to ensure the quality of the dietary supplement.
Specifically, ***
You did not implement quality control operations to ensure the quality of the dietary supplement.
Specifically, ***
You did not establish specifications [for the packaging and labeling of the finished dietary supplement] [to
ensure that you used the specified packaging] [to ensure that you applied the specified label].
Specifically, ***
You did not conduct appropriate tests or examinations to determine compliance with the specifications
established for [identity] [purity] [strength] [composition] [limits on contamination that may adulterate or
that may lead to adulteration of the dietary supplement]. Specifically, ***
You did not make and keep documentation of your qualification of a supplier. Specifically, ***
Your quality control personnel did not approve or reject [processes] [specifications] [written procedures]
[controls] [tests] [examinations] [deviations or modifications] that may affect the identity, purity, strength,
or composition of a dietary supplement. Specifically, ***
You did not have required records, or copies of such records, readily available during the retention period
for inspection and copying by FDA when requested. Specifically, ***
You did not make and keep records of a material review and disposition decision on a returned dietary
Critical factors that may affect the scheduled process are not specified in the scheduled process.
Specifically, ***
A review of processing and production records by a qualified representative of plant management was
not done [within one working day after the completion of the process] [before shipment or release for
distribution] to determine [completeness of the records] [whether product was processed as specified by
the scheduled process]. Specifically, ***
Failure to use adequate [sterilization] [irradiation] [pasteurization] [freezing] [refrigeration] [pH control]
[water activity control] to destroy or prevent the growth of undesirable microorganisms in food.
Specifically, ***
Failure to take effective measures to protect food transported by conveyor from contamination.
Specifically, ***
Responsibility for assuring compliance with current good manufacturing practices relating to personnel
has not been assigned to competent supervisory personnel. Specifically, ***
Your HACCP plan is not specific to [each location where juice is processed] [each type of juice processed].
Specifically, ***
You did not review [all of] your [critical control point monitoring] [corrective action] records within one
week (7 days) of the day the records are made. Specifically, ***
Your [written hazard analysis] [written HACCP plan], required by the juice HACCP regulation, [was] [were]
not signed and dated [upon initial acceptance] [upon modification] [upon verification] [upon validation]
[by the most responsible individual onsite at the processing facility or by a higher level official].
Specifically, ***
You did not calibrate instruments or controls used in manufacturing or testing a component or dietary
supplement [before the first use] [at the frequency specified in writing by the manufacturer or at routine
intervals or as necessary] to ensure the accuracy and precision of the instruments or controls.
Specifically, ***
You did not [maintain] [clean] [sanitize] equipment and utensils used to manufacture, package, label, or
hold components or dietary supplements. Specifically, ***
The written instructions in your master manufacturing record did not include specifications for each
point, step, or stage in the manufacturing process where control is necessary to ensure the quality of the
dietary supplement. Specifically, ***
A qualified person did not investigate a product complaint that involved a possible failure of a dietary
supplement to meet a specification, or other requirement. Specifically, ***
You did not provide adequate documentation of your basis for determining that compliance with the
specification[s] you selected for identity, purity, strength, and composition will ensure that the finished
batch of dietary supplement meets the specification[s]. Specifically, ***
You did not ensure that the tests or examinations that you used to determine whether the specifications
are met are appropriate, scientifically valid methods. Specifically, ***
You do not have quality control operations for [packaging] [labeling]. Specifically, ***
You did not make and keep documentation of [the date of the use] [maintenance] [cleaning] [sanitizing]
of the equipment. Specifically, ***
The presence of flies is not monitored by appropriate monitoring methods. Specifically,***
Lack of corrosion-resistant food contact surfaces. Specifically, ***
Your written hazard analysis does not consist of [an identification of food hazards] [an evaluation of each
food hazard identified to determine if it must be addressed in the HACCP plan] [an identification of the
control measures that can be applied] [a review of your current process to determine whether
modifications are necessary] [an identification of critical control points]. Specifically, ***
Your HACCP plan does not include control measures that will consistently produce a 5 log reduction in the
most resistant microorganism of public health significance that is likely to occur in the juice, for a period
at least as long as the shelf life of the product. Specifically, ***
Your hand-washing facilities [are not adequate] [are not convenient] [do not furnish running water at a
suitable temperature]. Specifically, ***
You did not maintain your physical plant in repair sufficient to prevent components, dietary supplements,
or contact surfaces from becoming contaminated. Specifically, ***
Your batch production records did not include the unique identifier that you assigned to [a component] [a
product that you received from a supplier for packaging or labeling as a dietary supplement] [the
packaging used] [the label used]. Specifically, ***
Your batch production records did not include an actual or representative label, or a cross-reference to
the physical location of the actual or representative label specified in the master manufacturing record.
Specifically, ***
You held [components] [dietary supplements] [packaging] [labels] under conditions that lead to mix-up,
contamination, or deterioration. Specifically, ***
The written instructions in your master manufacturing did not include instructions for corrective action
plans to use when specifications are not met. Specifically, ***
You did not examine, before [packaging] [labeling] operations, [packaging] [labels] for each batch of
dietary supplement to determine whether the [packaging] [labels] conformed to the master
manufacturing record. Specifically, ***
You did not implement a system of production and process controls that covers all stages of
manufacturing, packaging, labeling, and holding of dietary supplements to ensure the quality of the
dietary supplement. Specifically, ***
You did not establish in-process specifications for a point, step, or stage in the master manufacturing
record where control is necessary to help ensure that specifications are met for [identity] [purity]
[strength] [composition]. Specifically, ***
Your quality control personnel approved and released for distribution a batch of dietary supplement that
did not meet established product specifications. Specifically, ***
You did not submit a reportable food report to FDA within 24 hours after you determined that a food was
a reportable food. Specifically, ***
You do not maintain practices that will protect against cross contamination when people move between
poultry houses. Specifically,***
The presence of rodents is not monitored by appropriate monitoring methods. Specifically,***
You did not take immediate corrective action to ensure that [no affected product entered into commerce]
[the cause of the deviation was corrected] [the HACCP plan was reassessed] when your verification
procedure revealed the need to take a corrective action. Specifically, ***
You did not immediately modify your HACCP plan after a reassessment revealed the plan to no longer be
adequate. Specifically, ***
The bottling room is not [adequately] separated from other plant operations or storage areas, so as to
protect against contamination. Specifically, ***
Failure to [store] [handle] [dispense] [use] [dispose of] single-service articles in a manner that protects
against the contamination of food and food-contact surfaces. Specifically, ***
Failure to clean and sanitize food-contact surfaces in wet-processing [before use] [after any interruption
during which they may have been contaminated], to preclude contamination with microorganisms.
Specifically, ***
Failure to use water which is [safe] [of adequate sanitary quality] in food and on food-contact surfaces.
Specifically, ***
You do not maintain records at the plant pertaining to physical inspection of equipment used for
treatment of product water, including the [type and date] [conditions found] [performance and
effectiveness of equipment]. Specifically, ***
You do not take and analyze samples of bottled drinking water for bacteriological testing at least once a
week [for each type of bottled drinking water produced during a day's production run]. Specifically, ***
Failure to receive and store [liquid] [dry] raw materials in bulk form in a manner which protects against
The [processing] [production] records do not contain sufficient additional information such as [product
code] [date] [container size] [product] to permit a public health hazard evaluation of the processes
applied to each [lot] [batch] [portion] of production. Specifically, ***
Failure to provide employees with [readily accessible] [adequate] toilet facilities. Specifically, ***
Failure to identify, from processor check or otherwise, deviations from the scheduled process or critical
factors which are out of control. Specifically, ***
Failure to process each low-acid canned food in conformity with at least the scheduled process.
Specifically, ***
Your HACCP plan does not list the [procedures for monitoring] [frequency of monitoring] at each critical
control point to ensure compliance with the critical limit. Specifically,
You did not take corrective action that ensured [the affected product was segregated] [a review of the
affected product was done to determine its acceptability] [affected product was not entered into
commerce] [the cause of the deviation was corrected] [the HACCP plan was reassessed in a timely
manner to determine if modifications were needed to reduce the risk of reoccurrence of the deviation
and modified as necessary]. Specifically, ***
You do not have a written HACCP plan that outlines controls for one or more food safety hazards that are
reasonably likely to occur. Specifically, ***
You did not validate that your HACCP plan is adequate to control food hazards [at least once within 12
months after implementation] [at least annually] [when a change in the process occurred that could have
affected the hazard analysis or altered the HACCP plan in any way]. Specifically, ***
You do not maintain [complete] records documenting [the implementation of your sanitation standard
operating procedure] [your written HACCP plan] [your written hazard analysis] [monitoring of critical
control points and their critical limits] [corrective actions taken in response to a deviation] [the
verification of your HACCP system] [the validation of your HACCP plan] [the validation of your hazard
analysis]. Specifically, ***
You did not take effective measures [to exclude pests from the physical plant] [to protect against
contamination of components, dietary supplements, and contact surfaces on the premises by pests].
Specifically, ***
You did not maintain your physical plant in a clean and sanitary condition. Specifically, ***
You did not [establish] [follow] written procedures for pest control. Specifically, ***
Your batch production records did not include [a statement of the actual yield] [a statement of the
percentage of theoretical yield] at appropriate phases of processing. Specifically, ***
Your batch production records did not include [the unique identifier assigned to labels used] [the quantity
of the labels used] [reconciliation of discrepancies between issuance and use of labels]. Specifically, ***
You did not [establish] [follow] written procedures for the requirements for components of dietary
You did not identify each unique lot within each unique shipment of components that you received in a
manner that allows you to trace the lot to [the supplier] [the date received] [the name of the component]
[the status of the component] [the dietary supplement that you manufactured and distributed].
Specifically, ***
You did not [establish] [follow] laboratory control processes for use of criteria for selecting standard
reference materials used in performing tests and examinations. Specifically, ***
You did not [establish] [follow] written procedures for packaging operations. Specifically, ***
You did not establish product specifications for limits on contamination that may adulterate, or that may
lead to adulteration of, the finished dietary supplement. Specifically, ***
You did not establish specifications to [sufficiently] assure that the product you received for packaging or
labeling as a dietary supplement is adequately identified and is consistent with your purchase order.
Specifically,
Your quality control personnel did not reject a [component] [dietary supplement] [package] [label] for
which a specification was not met. Specifically, ***
You did not [establish] [follow] written procedures for quality control operations for conducting a material
review and making a disposition decision. Specifically, ***
Your pullet environment is not tested for SE when pullets are 14 to 16 weeks of age. Specifically,***
Potential harborages for pests in and outside your poultry house have not been eliminated by [removing
debris within a poultry house] [removing debris and vegetation outside the poultry house].
Specifically,***
Environmental testing for SE, using approved methods, was not done in a poultry house when any group
of laying hens constituting the flock was 40 to 45 weeks of age. Specifically,***
For testing to detect SE in environmental samples, you did not have the sample testing conducted by the
method entitled "Environmental Sampling and Detection of Salmonella in Poultry Houses." most current
edition, or an equivalent method in accuracy, precision and sensitivity in detecting SE. Specifically,***
You do not maintain records documenting compliance with refrigeration requirements. Specifically***
An inadequate number of instruments used for [measuring] [regulating] [recording] conditions that
control or prevent the growth of undesirable microorganisms. Specifically,***
Employees who appear to have an [illness] [open lesion] [abnormal source of microbial contamination]
are not excluded from operations where there is a reasonable possibility of [food] [food contact surfaces]
[food packaging materials] becoming contaminated. Specifically, ***
Failure to properly maintain operating systems for waste treatment and disposal so that they do not
constitute a source of contamination in areas where food is exposed. Specifically, ***
The [product] [operations] source water that is obtained from other than a public water system is not
sampled and analyzed for microbiological contaminants at least once each week. Specifically, ***
Failure to provide [adequate ventilation] [control equipment] to minimize odors and vapors in areas
where they may contaminate food. Specifically, ***
Storage or use of toxic materials which are not required to maintain clean and sanitary conditions, are
unnecessary for use in laboratory testing procedures, are unnecessary for plant and equipment
maintenance, and are unnecessary for use in plant operations. Specifically, ***
You do not take and analyze samples of bottled drinking water for [chemical] [physical] [radiological]
testing at least annually [for each type of bottled drinking water produced during a day's production run].
Specifically, ***
Failure to [inspect] [segregate] [handle] raw materials to ascertain that they are clean and suitable for
processing into food. Specifically, ***
Departures from a scheduled process having a possible bearing on public health or the safety of a food
are not [noted] [identified] [recorded] [made the subject of a separate file (or log identifying the
appropriate data) delineating them]. Specifically, ***
Systems that discharge waste water or sewage are cross-connected to systems that carry water for food
or food manufacturing. Specifically, ***
Forms used to record critical factors lack [closing machine vacuum in vacuum-packed products]
[maximum fill-in weight] [drained weight] [critical factors specified in the scheduled process]. Specifically,
***
Maintenance of the grounds is inadequate to protect against contamination of food. Specifically, ***
Failure to file with FDA changes in previously filed scheduled processes, where processing parameters
were higher or longer, when the processes became regularly scheduled. Specifically, ***
Failure to have personnel involved in [retorts] [thermal processing systems] [aseptic processing and
packaging systems] [thermal processing systems] [container closure inspections] under the operating
supervision of a person who has attended and satisfactorily completed a school approved by the
Commissioner. Specifically, ***
Your required records do not [always] include [the name of the processor] [the name of the importer]
[the location of the processor] [the location of the importer] [the date and time of the activity] [the
signature or initials of the person performing the operation or creating the record] [the identity of the
product] [the production code]. Specifically, ***
You did not develop, or have developed for you, a written hazard analysis to determine whether there are
food hazards that are reasonably likely to occur for [each type of] juice you produce. Specifically, ***
. Specifically, ***
Your physical plant did not use adequate screening or other protection against pests. Specifically, ***
Your equipment or utensils are not maintained to protect components and dietary supplements from
being contaminated. Specifically, ***
Your batch production record did not accurately follow the appropriate master manufacturing record.
Specifically, ***
Your batch production records did not include documentation that quality control personnel approved
and released, or rejected, a batch for distribution. Specifically, ***
You did not take necessary precautions during the manufacture of a dietary supplement to prevent
contamination of [components] [dietary supplements]. Specifically, ***
You did not conduct manufacturing operations in accordance with adequate sanitation principles.
Specifically, ***
Your master manufacturing record did not establish [controls] [procedures] to ensure that each batch met
You did not establish a corrective action plan to use when an established specification is not met.
Specifically, ***
Your reserve sample of a dietary supplement was not held using the same container-closure system in
which the packaged and labeled dietary supplement was distributed. Specifically, ***
Eggs were not [held ] [transported] at or below 45 deg. F beginning 36 hours after time of lay.
Specifically,***
Your written SE plan does not [bear a date] [carry the signature(s) and not the initials of the person(s)
who administer the plan]. Specifically,***
You have not provided evidence that the [fish] [fishery products] you import have been processed under
conditions that comply with the Seafood HACCP regulation. Specifically, ***
Operators of [processing systems] [retorts] [aseptic processing systems] [product formulating systems]
are not under the operating supervision of a person that has attended and satisfactorily completed, a
school approved by the Commissioner. Specifically, ***
Supervisors have not satisfactorily completed training in a school approved by the Commissioner for
areas under their responsibility. Specifically, ***
Scheduled processes for low-acid foods have not been established by qualified persons having expert
knowledge of thermal processing. Specifically, ***
Process deviations were not recorded in a separate file or log that details both the deviations and the
actions taken. Specifically, ***
Failure of the reviewer to [sign or initial] [date] the [processing records] [production records] [recording
temperature chart(s)] after the completion of the processing of a low-acid food product. Specifically, ***
The function of supervising overall sanitation of the plant has not been designated to the supervision of
one or more competent individuals assigned responsibility for this function. Specifically, ***
Failure to treat and maintain [batters] [breading] [sauces] [gravies] [dressings and similar preparations] in
a manner that protects against [contamination] [growth of microorganisms]. Specifically, ***
Food which has become contaminated to the extent of being adulterated within the meaning of the Act is
not rejected or if permissible, treated or processed to eliminate the contamination.. Specifically, ***
The system, equipment, and procedures used for thermal processing of foods in hermetically sealed
containers [did not conform to the applicable requirements of 21 CFR 113.40] [did not conform to
methods and controls specified in the scheduled process] [were not operated and administered in a
manner that ensures commercial sterility is achieved]. Specifically, ***
Each container is not marked with an identifying code permanently visible to the naked eye. Specifically,
***
Records identifying initial distribution of finished product are not maintained. Specifically, ***
Water [used] [re-used] to [wash] [rinse] [convey] food is not [safe] [of adequate sanitary quality].
Specifically, ***
Failure to inspect [containers] [carriers] of raw materials upon receipt to ensure that their condition does
not contribute to the contamination or deterioration of food. Specifically, ***
Food-contact surfaces are not made of non-toxic materials. Specifically, ***
Failure to register with the FDA information including the name, principal place of business and the
location of the processing establishment within 10 days after engaging in the manufacture, processing
and packaging of low-acid canned foods. Specifically, ***
You did not review [some of] your calibration records within a reasonable time after the records were
made. Specifically, ***
You did not take corrective action that ensured [affected product was not entered into commerce] [the
cause of the deviation was corrected]. Specifically, ***
You do not [always] have or have not implemented a sanitation standard operating procedure that
addresses sanitation conditions and practices before, during and after processing. Specifically, ***
Your HACCP plan lists monitoring [procedures] [frequencies of performing procedures] that do not ensure
compliance with the critical limits. Specifically, ***
Your HACCP plan does not provide for a recordkeeping system that documents the monitoring of critical
control points. Specifically, ***
You did not [establish] [follow] written procedures for determining personnel qualification requirements.
Specifically, ***
You did not [establish] [follow] written procedures for fulfilling the requirements for equipment and
utensils. Specifically, ***
You did not determine the suitability of the automated, mechanical, or electronic equipment by ensuring
that the equipment is capable of operating satisfactorily within the operating limits required by the
process. Specifically, ***
Your batch production records did not include the identity of equipment and processing lines used in
producing the batch. Specifically, ***
You did not quarantine components before you used them in the manufacture of a dietary supplement.
Specifically, ***
You did not identify each unique lot within each unique shipment of packaging in a manner that allows
you to trace the lot to [the supplier] [the date received] [the name of the packaging] [the status of the
packaging] [the dietary supplement that you distributed]. Specifically, ***
You did not make and keep receiving records for [components] [packaging] [labels] [products you
received for packaging or labeling as a dietary supplement]. Specifically, ***
You did not identify and use an appropriate scientifically valid method for each established specification
for which testing or examination is required to determine whether the specification was met. Specifically,
***
You did not make and keep records of the written procedures for manufacturing operations. Specifically,
***
You did not use effective measures to protect against the inclusion of metal or other foreign material in
[components] [dietary supplements]. Specifically, ***
The specific actions in your written instructions in your master manufacturing record for a manual
operation did not include one person to add and another person to verify the addition of the
components. Specifically, ***
Your master manufacturing record did not include the [identity] [weight or measure] of each dietary
ingredient that will be declared on the Supplement Facts label. Specifically, ***
Your master manufacturing record did not identify specifications for the points, steps, or stages in the
manufacturing process where control is necessary to ensure that the dietary supplement is packaged and
labeled as specified in the master manufacturing record. Specifically, ***
You did not assign a batch, lot, or control number to each lot of packaged and labeled dietary supplement
from a finished batch of dietary supplement. Specifically, ***
You did not control the [issuance] [use] of labels, Specifically, ***
You did not make and keep a written record of every product complaint that was related to good
manufacturing practice. Specifically, ***
You did not confirm the identity of components. Specifically, ***
You did not monitor the in-process points, steps, or stages, where control is necessary to ensure that the
quality of the finished batch of dietary supplement, to determine whether the in-process specifications
are met. Specifically, ***
You did not collect representative samples [of a subset] of finished batches of dietary supplements that
you manufacture [before releasing for distribution] to verify that the finished batch of dietary supplement
meets established product specifications. Specifically, ***
Your reserve sample did not consist of at least twice the quantity necessary for all tests or examinations
to determine whether or not the dietary supplement meets product specifications. Specifically, ***
You did not make and keep records of established specifications. Specifically, ***
Your quality control personnel did not conduct a material review and make a disposition decision when a
batch deviated from the master manufacturing record. Specifically, ***
Your quality control operations did not include reviewing and approving [master manufacturing records]
[modifications to the master manufacturing records]. Specifically, ***
You did not make and keep [written procedures for the responsibilities of the quality control operations
for conducting a material review and making a disposition decision] [written procedures for approving or
rejecting any reprocessing]. Specifically, ***
You did not keep required written records for 1 year past the shelf life date or for 2 years beyond the date
of distribution of the last batch of dietary supplements associated with the records. Specifically, ***
You did not identify and quarantine returned dietary supplements until quality control personnel
conducted a material review and made a disposition decision. Specifically, ***
You did not make and keep documentation of calibrations for instruments or controls that you use in
manufacturing or testing a component or dietary supplement. Specifically, ***
Visitors are not limited [on the farm] [in the poultry houses]. Specifically,***
You did not make available for official review and copying at reasonable times [all records] [all plans and
procedures] required by the regulations. Specifically, ***
You do not take and analyze samples of [product] [operations] source water [as often as necessary] [at
least once every year for chemical contamination] [at least once every four years for radiological
contaminants]. Specifically, ***
You do not [fill] [cap] [close] [seal] [package] containers in a sanitary manner so as to preclude
contamination of the bottled drinking water. Specifically, ***
Not all plant equipment and utensils are suitable for their intended use. Specifically, ***
The [guard dog] [guard dogs] [guide dog] [guide dogs] in the plant are likely to result in the contamination
of [food] [food-contact surfaces] [food-packaging materials]. Specifically, ***
Food contact surfaces used for [manufacturing] [holding] low-moisture food were [wet] [insanitary] at
time of use. Specifically, ***
The [conveyance] [storage] [disposal] of [rubbish] [offal] does not protect against contamination of [food]
[food-contact surfaces] [water supplies] [ground surfaces]. Specifically, ***
Failure to use a water supply that is [sufficient for the operations] [derived from an adequate source].
Specifically, ***
Mercury-in-glass thermometers were not tested against a known accurate standard thermometer [upon
installation] [yearly] to ensure accuracy. Specifically, ***
Failure to properly adjust the temperature-recording device. The temperature recorded on the
temperature-recording device chart [was higher than] [did not agree with] a known accurate mercury-in-
glass thermometer. Specifically, ***
Failure to fully reprocess, thermally process as a low-acid food under 21 CFR 113, or set aside for further
evaluation as to any potential public health significance, a portion of food which [deviated from a
scheduled process] [had an equilibrium pH of the finished product higher than 4.6]. Specifically, ***
Failure to provide the FDA, after written request, any process and procedure information deemed
necessary to determine the adequacy of the process. Specifically, ***
In evaluating what food hazards are reasonably likely to occur, [you] [the person who performed the
evaluation for you] did not consider [microbiological contamination] [parasites] [chemical contamination]
[unlawful pesticide residues] [decomposition] [natural toxins] [use of unapproved color or food additives]
[presence of undeclared ingredients that may be allergens] [physical hazards]. Specifically, ***
Your records do not [always] contain the actual values and observations obtained during monitoring.
Specifically, ***
Your HACCP plan includes a corrective action plan. There was a deviation from a critical limit and you did
not take corrective action that ensured [product that was injurious to health or otherwise adulterated did
not enter commerce] [the cause of the deviation was corrected]. Specifically, ***
Your personnel did not use hygienic practices to the extent necessary to protect against contamination of
components, dietary supplements, or contact surfaces. Specifically, ***
You did not [identify] [hold] cleaning compounds, sanitizing agents, pesticides, pesticide chemicals, or
other toxic materials in a manner that protects against contamination of components, dietary
supplements, or contact surfaces. Specifically, ***
The plumbing in your physical plant allows [backflow from] [cross connection between] piping systems
that discharge waste water or sewage and piping systems that carry water used for manufacturing dietary
supplements, for cleaning contact surfaces, or for use in bathrooms or hand-washing facilities.
Specifically, ***
Your [floors] [walls] [ceilings] were not designed and constructed so they can be adequately cleaned and
kept clean and in good repair. Specifically, ***
You did not make and keep records of the written procedures for [cleaning the physical plant] [pest
control]. Specifically, ***
Your freezer, refrigerator, or other cold storage compartments that you use to hold components or dietary
supplements does not have either an automated device for regulating temperature or an automated
alarm system to indicate a significant temperature change. Specifically, ***
Your batch production records did not include the actual results obtained during a monitoring operation.
Specifically, ***
Your batch production records did not include documentation, at the time of performance, of the
manufacture of the batch. Specifically, ***
Your batch production records did not include initials of the person responsible for verifying the addition
of components to the batch. Specifically, ***
Your batch production records did not include [the unique identifier assigned to packaging used] [the
quantity of the packaging used]. Specifically, ***
Your batch production records did not include documentation that quality control personnel reviewed the
batch production record. Specifically, ***
You did not identify each unique lot within each unique shipment of labels in a manner that allows you to
trace the lot to [the supplier] [the date received] [the name of the labels] [the status of the labels] [the
dietary supplement that you distributed]. Specifically, ***
You did not [establish] [follow] written procedures for laboratory operations. Specifically, ***
You did not [establish] [follow] laboratory control processes. Specifically, ***
You did not verify that the laboratory examination and testing methodologies are appropriate for their
intended use. Specifically, ***
The specific actions in your written instructions in your master manufacturing record for a manual
operation did not include one person weighing or measuring and another person verifying the weight or
measure of components. Specifically, ***
The written instructions in your master manufacturing record did not include specific actions necessary to
perform and verify points, steps, or stages in the manufacturing process where control is necessary to
ensure the quality of the dietary supplement. Specifically, ***
You were not able to determine the complete manufacturing history and control of a packaged and
labeled dietary supplement through distribution. Specifically, ***
A qualified person did not review a product complaint to determine whether the product complaint
involves a possible failure of a dietary supplement to meet specifications or any other requirements.
Specifically, ***
You did not provide adequate documentation of your basis for why meeting the in-process specifications,
in combination with meeting component specifications, will help ensure that the specifications are met
for [the identity] [purity] [strength] [composition]. Specifically, ***
You did not establish specifications to [sufficiently] assure that the product you received for packaging or
labeling as a dietary supplement is adequately identified and is consistent with your purchase order.
Specifically, ***
You did not determine whether you met established specifications to provide sufficient assurance that
product you receive from a supplier is adequately identified and is consistent with your purchase order.
Specifically, ***
You did not maintain documentation of how you qualified the supplier of a component. Specifically, ***
You did not periodically re-confirm the supplier's certificate of analysis for a component. Specifically, ***
You did not select one or more established specifications for [identity] [purity] [strength] [composition]
[limits on contamination that may adulterate or that may lead to adulteration of the dietary supplement]
that, if tested or examined on the finished batches of the dietary supplement, would verify that the
production and process control system is producing a dietary supplement that meets all product
Your quality control operations did not include determining whether [components] [packaging] [labels]
conform to established specifications. Specifically, ***
Your quality control operations did not include approving, and releasing from quarantine, all
[components] [packaging] [labels] before they were used. Specifically, ***
Your quality control operations did not include approving and releasing, or rejecting, each finished batch
for distribution. Specifically, ***
The poultry house environmental sampling plan was not appropriate to the poultry house layout.
Specifically,***
You did not maintain records documenting compliance with biosecurity measures. Specifically,***
The records that relate to the general adequacy of your [processes] [equipment] were not maintained for
at least two years after their applicability to the product you produced. Specifically, ***
Failure to provide accurate timing devices to ensure that the processing and venting times specified in the
scheduled process are achieved. Specifically, ***
Forms used to record processing or production information lack the [product] [code number] [date]
[retort or processing system number] [container size] [approximate number of containers per coding
interval] [initial temperature] [actual processing time] [mercury-in-glass thermometer readings]
[recording thermometer readings] [appropriate processing data]. Specifically, ***
Not all material used for product water contact surfaces [is nontoxic and nonabsorbent] [can be
adequately cleaned and sanitized] [is in compliance with section 409 of the Federal Food, Drug and
Cosmetic Act]. Specifically, ***
Failure to have a deviation from the scheduled process evaluated for public health significance by a
competent processing authority. Specifically, ***
Written records of all container closure examinations did not specify [product code] [date of container
closure inspection] [time of container closure inspection] [measurements obtained] [corrective actions
taken]. Specifically, ***
Failure to install a mercury-in glass thermometer on each retort. Specifically, ***
There is no assurance that [raw materials] [ingredients] which are susceptible to contamination with
aflatoxin or other natural toxins comply with current FDA standards before being incorporated into food.
Specifically, ***
There is no assurance that [raw materials] [ingredients] [rework materials] which are susceptible to
contamination with [pests] [undesirable microorganisms] [extraneous materials] comply with current FDA
standards and defect action levels. Specifically, ***
You do not adequately [clean] [sanitize] [inspect] multiservice primary containers just prior to the
containers being filled, capped and sealed. Specifically, ***
You do not [sample] [test] cleaning and sanitizing solutions [as often as necessary] to assure adequate
performance. Specifically, ***
Failure to thaw frozen raw materials in a manner that prevents them and other ingredients from
becoming adulterated. Specifically, ***
Failure to dispose of adulterated [food] [raw materials] in a manner which protects against the
contamination of other food. Specifically, ***
Critical factors were not [measured] [recorded on the processing record] at intervals of sufficient
frequency to ensure that the factors are within the limits specified in the scheduled process. Specifically,
***
Failure to record the [procedures used in the evaluation of process deviations] [results of process
deviation evaluations]. Specifically, ***
Failure to record observations of visual closure examinations performed by a qualified person during
production. Specifically, ***
Failure to [have a qualified person] perform appropriate detailed inspections and tests [at intervals of
sufficient frequency] to ensure proper closing machine performance and consistently reliable hermetic
seal production. Specifically, ***
Failure to hold [raw materials] [rework materials] [ingredients] at proper temperature and humidity to
prevent the food from becoming adulterated. Specifically, ***
Failure to provide FDA, when requested in writing, with information concerning processes and
procedures deemed necessary to determine the adequacy of the process. Specifically, ***
Your review of [calibration] [in-process testing][end-product testing] records does not ensure [that the
records are complete] [that the activities occurred in accordance with your written procedures] [occurred
within a reasonable time after the records were made]. Specifically, ***
You do not have written procedures that describe [product specifications] [affirmative steps] to ensure
that juice you receive for import into the United States was processed in accordance with the juice
HACCP regulation. Specifically, ***
Processing and other information is not [always] entered on your records at the time it is observed.
Specifically, ***
You do not conduct the 5-log reduction process and perform final packaging of your juice within a single
production facility operating under current good manufacturing practices. Specifically, ***
You do not maintain records of [sampling] [testing] of cleaning and sanitizing solutions. Specifically, ***
Your HACCP plan does not list the [procedures for monitoring] [frequency of monitoring] at each critical
control point to ensure compliance with the critical limits. Specifically, ***
Your personnel did not wear [effective] hair restraints [in an effective manner]. Specifically, ***
You have not assigned qualified personnel to supervise the [manufacturing] [packaging] [labeling]
[holding] of dietary supplements]. Specifically, ***
You did not make and keep written procedures for [preventing microbial contamination from sick or
infected personnel] [hygienic practices] [determining personnel qualification requirements]. Specifically,
***
You allowed [animals] [pests] in your physical plant. Specifically, ***
You [did not have] [did not use] separate or defined areas of adequate size or other control systems to
prevent contamination or mix-ups of components or dietary supplement by separating the
[manufacturing] [packaging] [labeling] [holding] of different product types. Specifically, ***
You did not [establish] [follow] written procedures for calibrating, inspecting, and checking automated,
mechanical, and electronic equipment. Specifically, ***
You did not design or select automated, mechanical, or electronic equipment that you use to
[manufacture] [package] [label] [hold] a dietary supplement to ensure that the dietary supplement
specifications are consistently met. Specifically, ***
You did not quarantine [packaging] [labels] before you used them in the manufacture of a dietary
You did not make and keep written procedures for fulfilling the requirements that apply to packaging and
labeling received. Specifically, ***
You did not make and keep written procedures for fulfilling the requirements that apply to product
received for packaging or labeling as a dietary supplement and for distribution rather than for return to
the supplier. Specifically,
Your reserve sample of a dietary supplement was not held using the same container-closure system in
which the packaged and labeled dietary supplement was distributed. Specifically, ***
You did not retain reserve samples for the required time. Specifically, ***
You did not make and keep records of product distribution. Specifically, ***
You did not [establish] [follow] written procedures for the tests and examinations conducted to
determine whether specifications are met. Specifically, ***
You did not [establish] [follow] sampling plans for obtaining representative samples. Specifically, ***
You did not [establish] [follow] sampling plans for obtaining representative samples of components.
Specifically, ***
You did not perform manufacturing operations under conditions and controls that protect against [the
potential for growth of microorganisms] [the potential for contamination]. Specifically, ***
The written instructions in your master manufacturing record did not include instructions to verify the
weight or measure and addition of components. Specifically, ***
You did not examine a representative sample of each batch of packaged and labeled dietary supplement
to determine whether the dietary supplement meets established specifications. Specifically, ***
Your quality control personnel did not [review and approve decisions about whether to investigate a
product complaint] [review and approve the findings and follow-up action of an investigation].
Specifically, ***
The written record of a product complaint did not include the [findings of the investigation] [follow-up
action taken]. Specifically, ***
You did not implement a system of production and process controls that covers all stages of
manufacturing, packaging, labeling, and holding of dietary supplements to ensure that the dietary
supplement is [packaged] [labeled] as specified in the master manufacturing record. Specifically, ***
You did not determine whether you met specifications established to ensure the quality of the dietary
You did not collect representative samples of each unique lot of [components] [packaging] [labels] that
you received from a supplier to determine whether the [components] [packaging] [labels] meet[s]
established specifications. Specifically, ***
Your quality control personnel did not [conduct required material reviews] [make required disposition
decisions]. Specifically,
You reprocessed a dietary supplement for which quality control personnel did not [conduct a material
review] [make a disposition decision to approve the reprocessing]. Specifically, ***
Your quality control personnel did not perform required operations for the [master manufacturing record]
[batch record] [manufacturing operations]. Specifically, ***
Your quality control personnel did not perform required operations for [packaging] [labeling] operations.
Specifically, ***
Your quality control personnel did not conduct a material review and make a disposition decision for a
specification established for the production and process control system that was not met. Specifically,
***
Your quality control personnel did not conduct a material review and make a disposition decision for an
unanticipated occurrence during the manufacturing operations that adulterated or may lead to
adulteration of the [component] [dietary supplement] [packaging]. Specifically, ***
The person who conducted a material review and made the disposition decision did not document the
material review and the disposition decision [at the time of performance]. Specifically, ***
You do not have quality control operations for [equipment] [instruments] [controls]. Specifically, ***
Your quality control operations did not include determining whether each finished batch conforms to
established product specifications. Specifically, ***
Your quality control operations did not include determining whether the finished [packaged] [labeled]
dietary supplement conforms to established specifications. Specifically, ***
You did not keep original records, true copies, or electronic records. Specifically, ***
You did not [establish] [follow] written procedures for quality control personnel to approve a returned
dietary supplement for reprocessing. Specifically, ***
You did not make and keep written procedures for [maintaining] [cleaning] [sanitizing] equipment and
utensils that are used to manufacture, package, label, or hold components or dietary supplements.
Specifically, ***
Your firm does not have a written SE prevention plan that is specific to [each farm] [the farm] where you
produce eggs. Specifically,***
You do not maintain practices that will protect against cross contamination when equipment is moved
among poultry houses. Specifically,***
When your monitoring indicated unacceptable fly activity within a poultry house, appropriate methods
were not used to achieve satisfactory fly control. Specifically,***
You do not maintain documentation [that pullets were "SE monitored" or were raised under "SE
monitored" conditions] [that adequate environmental testing records for pullets were kept as required by
CFR regulations]. Specifically,***
You did not maintain records documenting compliance with rodent and other pest control measures.
Specifically,***
You did not maintain records documenting compliance with cleaning and disinfection procedures
performed at depopulation. Specifically,***
Your HACCP Plan for [smoked] [smoke flavored] fishery product does not include controls for Clostridium
botulinum. Specifically, ***
The records that document the performance and results of the affirmative step you chose are not in
English. Specifically, ***
Failure to ensure that compressed air or other gases [mechanically introduced into food] [used to clean
food-contact surfaces or equipment] have been treated in such a way that foods are not contaminated
with unlawful indirect food additives. Specifically, ***
Failure to dispose of sewage into an adequate sewerage system or by other adequate means. Specifically,
***
Hermetically sealed containers do not have an identifying code permanently visible to the naked eye.
Specifically ***
You do not conduct processing operations in a sealed system under pressure, and you do not provide
[adequate] protection against contamination of the water and the system. Specifically, ***
The [washing] [sanitizing] operation for containers for bottled drinking water is not positioned within the
room so as to minimize any possible post-sanitation contamination of the containers before they enter
the bottling room. Specifically, ***
Required information was not entered on designated forms at the time the observation was made by the
retort or processing system operator or designated person. Specifically, ***
You do not maintain records on file at the plant pertaining to [approval of the source water by
government agencies] [sampling and analyses for which you are responsible]. Specifically, ***
You do not adequately [clean] [sanitize] the product water-contact surfaces of all [multiservice
containers] [utensils] [pipes] [equipment] used in the [transportation] [processing] [handling] [storage] of
product water. Specifically, ***
Operating processes for each product and container size were not [posted in a conspicuous place near
the processing equipment] [readily available to the retort or processing system operator] [readily
available to FDA investigators]. Specifically, ***
No corrective action was taken, e.g. fully reprocessing or setting the lot aside for evaluation, when a
deviation from the scheduled process was found. Specifically, ***
Plumbing is not [of adequate size and design] [adequately installed and maintained] to carry sufficient
quantities of water to required locations throughout the plant. Specifically, ***
The mercury-in-glass thermometer was not the reference thermometer for indicating processing
temperatures. Specifically, ***
Failure to adequately [process to] [maintain at] a safe moisture level foods that rely on the control of
water activity to prevent the growth of undesirable microorganisms. Specifically, ***
Each retort did not have an accurate temperature-recording device. Specifically, ***
temperature-recording device chart [was higher than] [did not agree with] the mercury-in-glass
thermometer during processing. Specifically, ***
Bleeders on horizontal retorts are not installed [approximately one foot from the outermost end at both
ends of the retort] [on top of the retort]. Specifically, ***
You do not keep records of [inspection and conditions found] [physical maintenance] [performance] for
mechanical washers. Specifically, ***
Sanitizing operations are not adequate to effect sanitation of the intended product water-contact
surfaces and critical areas. They do not meet the minimum times and intensities required by the
regulations. Specifically, ***
You did not retain at the plant required records for at least 2 years. Specifically, ***
There was no means to prevent unauthorized changes in adjustment to the temperature-recording
device. Specifically, ***
Samples for [bacteriological] [chemical] [physical] [radiological] analysis are not primary containers or
unit packages from a batch or segment of a continuous run for each type of bottled drinking water.
Specifically, ***
You do not visually or electronically inspect filled containers to assure they are [sound] [properly capped
or sealed] [properly coded and labeled]. Specifically, ***
Failure to adequately [wash] [clean] raw materials as necessary to remove soil or other contamination.
Specifically, ***
Failure to identify material scheduled for rework as such. Specifically, ***
Minimum headspace of containers in each retort load to be processed was not [measured] [recorded] at
intervals of sufficient frequency to ensure that the headspace is as specified in the scheduled process.
Specifically, ***
Each product sterilizer does not have a mercury-in glass thermometer (MIG) or equivalent temperature-
indicating device. Specifically, ***
Observations and measurements of operating conditions were not [made] [recorded] at intervals of
sufficient frequency to ensure commercial sterility. Specifically, ***
Acidified foods are not manufactured, processed and packaged to [achieve within the time designated in
the scheduled process] [maintain] a pH value of 4.6 or lower in all finished foods. Specifically, ***
Acidified foods are not thermally processed to an extent that is sufficient to destroy the vegetative cells of
microorganisms of public health significance and those of nonhealth significance capable of growing in
the food. Specifically, ***
The packing period is not changed often enough to enable ready identification of lots during sale and
distribution Specifically, ***
Process deviations are not evaluated by a competent processing authority in accordance with procedures
recognized by competent processing authorities as being adequate to detect any potential hazard to
public health. Specifically, ***
Failure to sanitize and thoroughly dry, prior to use, food-contact surfaces which have been wet cleaned.
Specifically, ***
Toilet doors open into areas where food is exposed to airborne contamination, and there are no
alternative means taken to prevent such contamination. Specifically, ***
Failure of the operator, closure supervisor, or other qualified person to visually examine [the top seam of
a can randomly selected from each seaming head] [the closure of a typical container]. Specifically ***
Failure to record teardown examinations of double seam cans [at intervals of sufficient frequency] [on
enough containers from each seaming station] to ensure maintenance of seam integrity. Specifically, ***
Failure to mark each hermetically sealed container of low-acid processed food with an identifying code
that is permanently visible to the naked eye. Specifically, ***
Failure to assure that the initial temperature of cans exposed to water during filling or operating of the
retort was not lower than the initial temperature specified in the scheduled process. Specifically, ***
Failure to provide for the type, range, and combination of variations encountered in commercial
production in establishing the scheduled process. Specifically, ***
You did not correct sanitation deficiencies in a timely manner. Specifically,***
Your [validation of the HACCP plan] [validation of the hazard analysis] was not done by an individual who
had successfully completed training in the application of HACCP principles to juice processing or
otherwise qualified through job experience to perform these function. Specifically, ***
You did not review [all of] your [calibration] [periodic end-product testing] [in-process testing] records
within a reasonable time after the records were made. Specifically, ***
You did not make all required records available for review and copying at reasonable times. Specifically,
***
Your HACCP plan does not list the validation [procedures] [frequencies] that have been developed to
ensure that the HACCP plan is adequate to control food hazards that are reasonably likely to occur.
Specifically, ***
You do not maintain records of [calibration of process-monitoring instruments] [periodic end-product or
in-process testing]. Specifically, ***
Your computerized records do not provide that appropriate controls are implemented to ensure the
integrity of the electronic data and signatures. Specifically, ***
You have not implemented affirmative steps to ensure juice you receive for import into the United States
was processed in accordance with the juice HACCP regulation. Specifically, ***
Your personnel used gloves that were not [intact] [clean] [in a sanitary condition] [made of impermeable
material]. Specifically, ***
You did not convey, store, and dispose of trash to [minimize development of odors] [minimize potential
for the trash to attract, harbor, or become a breeding place for pests] [protect against contamination of
components, dietary supplements, contact surfaces, water supplies, and grounds surrounding your
physical plant] [control hazardous waste to prevent contamination of components, dietary supplements,
and contact surfaces]. Specifically, ***
You did not assign one or more employees to supervise overall sanitation. Specifically, ***
You did not [properly store equipment] [remove litter and waste] [cut weeds or grass] within the
immediate vicinity of the physical plant. Specifically, ***
The plumbing in your physical plant was not adequate to avoid being a source of contamination to
components, dietary supplements, water supplies, or any contact surface or creating an unsanitary
condition. Specifically, ***
You [did not have] [did not use] separate or defined areas of adequate size or other control systems to
prevent contamination or mix-ups of components or dietary supplements by separating components,
dietary supplements, packaging, and labels that are to be used in manufacturing from those that are
awaiting material review and disposition decision, reprocessing, or disposal. Specifically, ***
Your equipment or utensils were not [installed] [maintained] to facilitate cleaning of [the equipment] [the
utensils] [all adjacent spaces]. Specifically, ***
You did not [maintain] [clean] [sanitize] equipment, utensils, and contact surfaces used to manufacture,
package, label, or hold components or dietary supplements. Specifically, ***
You did not [establish] [use] appropriate controls to ensure that your automated, mechanical, or
electronic equipment functions in accordance with its intended use. Specifically, ***
Your batch production records did not include the [identity] [weight or measure] of each component
used. Specifically, ***
Your batch production records did not include the results of testing or examination performed during
batch production, or a cross-reference to such results. Specifically, ***
Your batch production records did not include initials of the persons performing each step. Specifically,
***
Your batch production records did not include the initials of the person responsible for verifying the
weight or measure of each component used in the batch. Specifically, ***
Your batch production records did not include documentation, at the time of performance, of [packaging]
[labeling] operations. Specifically, ***
Your batch production records did not include documentation that quality control personnel reviewed the
results of tests and examinations. Specifically, ***
Your batch production records did not include documentation that quality control personnel approved
and released, or rejected, the packaged and labeled dietary supplement. Specifically, ***
Your batch production records did not include documentation of reprocessing. Specifically, ***
You did not [establish] [follow] written procedures for the requirements for labels received. Specifically,
***
You did not [establish] [follow] written procedures for the requirements for product received for
packaging or labeling as a dietary supplement. Specifically, ***
You did not collect representative samples of components while the components were quarantined.
Specifically, ***
You did not use a unique identifier whenever you recorded the disposition of [each unique lot within
each unique shipment of components that you received] [each lot of components that you produced].
Specifically, ***
You did not hold components under conditions that will [protect against contamination] [protect against
deterioration] [avoid mix-ups]. Specifically, ***
You did not collect representative samples of received product while the received product was
quarantined. Specifically, ***
Your quality control personnel did not review and approve documentation to determine whether
quarantined received product meets established specifications. Specifically, ***
You did not make and keep documentation that the requirements that apply to production and process
control for packaging received were met. Specifically, ***
You did not identify and hold in-process material under conditions that protect against mix-up,
contamination, or deterioration. Specifically, ***
You did not perform chemical, microbiological, or other testing, as necessary to prevent the use of
contaminated components. Specifically, ***
The written instructions in your master manufacturing record did not include specifications for each
point, step, or stage in the manufacturing process where control is necessary to ensure that the dietary
supplement is packaged and labeled as specified in the master manufacturing record. Specifically, ***
Your master manufacturing record did not include a statement of intentional overage amount of a dietary
ingredient. Specifically, ***
Your master manufacturing record did not include the identity of each ingredient that will be declared on
the ingredients list of the dietary supplement. Specifically, ***
Your master manufacturing record did not include an accurate weight or measure of each component to
be used. Specifically, ***
Your master manufacturing record did not include the [name] [strength] [concentration] [weight]
[measure] of each dietary ingredient for each batch size. Specifically, ***
Your quality control personnel did not approve or reject each batch of [repackaged] [relabeled] dietary
supplement prior to its release for distribution. Specifically, ***
You did not examine a representative sample of each batch of [repackaged] [relabeled] dietary
supplement to determine whether the established specifications were met. Specifically, ***
You did not clean and sanitize [filling and packaging equipment] [utensils] [dietary supplement
packaging], as appropriate. Specifically, ***
You did not control the reconciliation of any issue and use [label discrepancies] [packaging discrepancies].
Specifically, ***
You did not take necessary actions to determine whether packaging for dietary supplements meets
specifications so that the condition of the packaging will ensure the quality of your dietary supplements.
Specifically, ***
Your [review about whether to investigate a product complaint] [findings and follow-up action of an
investigation performed] did not extend to all relevant batches and records. Specifically, ***
You did not determine whether you met in-process specifications to ensure the [purity] [strength]
[composition] of the dietary supplements. Specifically, ***
You did not [visually examine a product that you received for packaging or labeling] [have documentation
that the product you received for packaging or labeling is adequately identified and is consistent with
your purchase order]. Specifically, ***
Your quality control personnel did not reject a component that did not meet an identity specification.
Specifically, ***
You did not collect representative samples of in-process materials for each manufactured batch as
specified in the master manufacturing record to determine whether the in-process materials met
established specifications. Specifically, ***
You did not collect representative samples of [each unique shipment] [each unique lot within each
unique shipment] product that you received for packaging or labeling as a dietary supplement to
determine whether the received product meets established specifications. Specifically, ***
Your quality control personnel did not determine that specifications established for the production and
process control system were met. Specifically, ***
Your quality control operations did not include ensuring that [tests] [examinations] required for your
laboratory operations were conducted. Specifically, ***
Your quality control operations did not include reviewing and approving the results of required [tests]
[examinations]. Specifically, ***
Your quality control personnel did not reject a [component] [dietary supplement] [package] [label] when
an established specification was not met. Specifically, ***
Your quality control operations did not include conducting a required material review and making a
required disposition decision for [components] [packaging] [labels] prior to [their] use. Specifically, ***
You do not have quality control operations required for the [master manufacturing record] [batch
production record] [manufacturing operations]. Specifically, ***
Your quality control operations for labeling did not include approving or rejecting any relabeling of a
packaged and labeled dietary supplement. Specifically, ***
You do not have quality control operations for returned dietary supplements. Specifically, ***
Your quality control operations for returned dietary supplements did not include conducting a required
material review and making a required disposition decision. Specifically, ***
Your quality control operations for returned dietary supplements did not include approving or rejecting
salvage and redistribution of a returned dietary supplement. Specifically, ***
Your documentation of your material review and disposition decision and follow-up did not include a
description of your investigation into the cause of the deviation from the specification or of the
unanticipated occurrence. Specifically, ***
You did not make and keep written procedures for [calibrating] [inspecting] [checking] automated,
mechanical, or electronic equipment. Specifically, ***
You did not make and keep documentation of the controls you use to ensure that equipment functions
according to its intended use. Specifically, ***
Your quality control personnel approved and released for distribution product received from a supplier
for [packaging] as a dietary supplement for which sufficient assurance was not provided [to adequately
identify the product] [to determine that the product was consistent with your purchase order].
Specifically, ***
You have not taken [adequate] steps to assure that there is no introduction or transfer of SE into or
among poultry houses. Specifically,***
Employees are allowed to keep birds at home. Specifically,***
Supervisory personnel responsible for ensuring compliance with the SE prevention plan(s) [have not
successfully completed training on SE prevention measures for egg production that is equivalent to that
received under a standardized curriculum recognized by FDA] [lack qualification through appropriate job
experience to administer the SE prevention measures]. Specifically,***
All records are not retained for 1 year after the flock to which they pertain has been taken permanently
out of production. Specifically,***
You do not have a written SE prevention plan. Specifically,***
You did not maintain records documenting compliance with environmental and egg sampling procedures.
Specifically,***
You are not able to retrieve and provide the records at your place of business within 24 hours of request
for official review. Specifically,***
Data and information reflecting compliance activities [is not entered on records at the time the activity is
performed or observed] [does not indicate the actual values]. Specifically***
Your computerized records do not provide that appropriate controls are implemented to ensure the
integrity of the electronic data and signatures. Specifically, ***
Container closure inspectors are not under the operating supervision of a person that has attended, and
satisfactorily completed, an appropriate school approved by the Commissioner. Specifically, ***
Personnel with adverse health conditions are not instructed to report to their supervisors. Specifically,
***
The [product] [operations] water [supply is] [supplies are] not from an approved source. Specifically, ***
Failure to properly maintain [roads] [yards] [parking lots] so that they do not constitute a source of
contamination in areas where food is exposed. Specifically, ***
The critical factors identified in the schedule process for the prevention of the growth of microorganisms
not destroyed by the thermal process are not controlled in a manner to ensure the limits established are
not exceeded. Specifically, ***
Distribution records are not maintained to identify the initial distribution of the finished product.
Specifically, ***
Copies of processing, production, and other required records for each lot of a low-acid food processed
were not retained at the processing plant [for a one year period following manufacture] [or other
reasonably accessible location for a total of a three-year record-retention period]. Specifically, ***
Forms used in recording specific processing and production information for aseptic processing and
packaging systems lack [the product temperature in the holding tube outlet] [the product temperature in
the final heater outlet] [differential pressure] [product flow rate] [sterilization media flow rate]
[sterilization media temperature] [retention time of containers and closures] [sterilization cycle times]
[sterilization cycle temperatures]. Specifically, ***
Finished bottled water does not comply with bottled water quality standards. Specifically, ***
A [locker] [lunchroom] for the employees [is] [are] not [separated from plant operations and storage
areas] [equipped with self-closing doors] [equipped with refuse containers] [maintained in a clean and
sanitary condition] [free of stored packaging or wrapping material or other processing supplies].
Specifically, ***
You do not inspect all product water-contact surfaces as often as necessary [to maintain the sanitary
condition of such surfaces] [to assure such surfaces are kept free of scale, evidence of oxidation, and
other residue]. Specifically, ***
After cleaning, you do not [transport] [store] all [multiservice containers] [utensils] [disassembled piping
and equipment] in such a manner as to [assure drainage] [be protected from contamination]. Specifically,
***
Single service [containers] [caps] [seals] are not [examined] [washed, rinsed and sanitized when
necessary] [handled in a sanitary manner] prior to use. Specifically, ***
No acceptable scientific methods of establishing heat sterilization processes or procedures recognized by
competent processing authorities were used in the determination of the scheduled process. Specifically,
***NOTE: CFSAN CONCURRENCE REQUIRED.
Retort venting procedures for each product and container size were not [posted in a conspicuous place
near the processing equipment] [readily available to the retort or processing system operator] [readily
available to FDA investigators]. Specifically, ***
A system of traffic control to prevent unretorted product from bypassing the retort system has not been
Forms used in recording specific processing and production information for food preservation methods
such as water activity in conjunction with thermal processing lack [product formulation] [scheduled
processes used] [thermal process] [associated and other critical factors] [results of water activity
determinations]. Specifically, ***
Forms used in recording specific processing and production information for other systems lack critical
factors specified in the formulation of the product or in the scheduled process. Specifically, ***
Recording thermometer charts were not identified by [date] [retort number] [data to correlate with
written records of lots processed]. Specifically ***
Failure to clean and sanitize utensils and food-contact surfaces of equipment in continuous wet-
processing operations as necessary. Specifically, ***
The retort or processing system operator or other designated person did not initial or sign each record
form. Specifically, ***
Written records of all container closure examinations are [not reviewed by management] [not reviewed
by management with sufficient frequency] to ensure that the containers are hermetically sealed.
Specifically, ***
Mercury-in-glass thermometers were not installed where they can be accurately and easily read.
Specifically, ***
[Raw materials] [Ingredients] which contain levels of microorganisms that may produce food poisoning or
other disease are not pasteurized or otherwise adequately treated. Specifically, ***
Failure to perform mechanical manufacturing steps so as to protect food against contamination.

Specifically, ***
Graduations on the temperature-recording device exceeded 2 degrees F within a range of 10 degrees F of
the processing temperature. Specifically, ***
There was no means to prevent unauthorized changes in adjustment to the temperature-recording
Failure to have a 1/16-inch or larger bleeder. Specifically, ***
Failure to install bleeders so that the operator can observe that they are functioning properly.
Specifically, ***
Methods used to analyze product water samples are not those approved by the government agencies
with jurisdiction over the product. Specifically, ***
Vents are not installed so as to provide complete removal of air from a retort before the process start
time. Specifically, ***
Timing of a process began before the retort [was properly vented] [processing temperature was reached].
Specifically, ***
Critical factors are not [measured] [recorded] on the processing record at intervals of sufficient frequency
to ensure that the factors are within limits specified in the scheduled process. Specifically, ***
Failure to position containers in the retort according to the scheduled process, for products in which
stratification or layering occurs. Specifically, ***
Failure to equip a retort with an automatic steam controller to maintain retort temperatures. Specifically,
***
Failure to install a mercury-in glass thermometer on each retort. Specifically, ***
A mercury-in-glass thermometer [lacked divisions readable to 1 degree F] [had a temperature range that
exceeded 17 degrees per inch of graduated scale]. Specifically, ***
A retort was used without replacing or repairing a mercury-in-glass thermometer [with a divided column]
[that could not be adjusted to the standard]. Specifically, ***
A mercury-in-glass thermometer was not the reference instrument used for indicating processing
temperatures. Specifically, ***
The working scale of the temperature-recording device chart was more than 55 degrees F per inch, within
a range of 20 degrees F of the processing temperature. Specifically, ***
The operator failed to [check] [record] the water level at intervals sufficient to ensure adequacy of the
water level. Specifically, ***
You do not identify each unit package from a [batch] [segment of a continuous production run] of bottled
drinking water with a production code which identifies [the particular batch] [the segment of production
run] [the day produced]. Specifically, ***
You do not record and maintain information as to the [kind of product] [volume produced] [date
produced] [lot code used] [distribution of finished product to wholesale and retail outlets]. Specifically,
***
You do not [sample] [inspect] all containers and closures to ascertain they are free from contamination.
Specifically, ***
There is no means of preventing unauthorized speed changes on retorts Specifically, ***
Failure to keep frozen raw materials frozen prior to use. Specifically, ***
Failure to use a proven effective method of reconditioning adulterated food. Specifically, ***
Mercury-in-glass thermometers were not installed where they can be accurately and easily read.
Specifically, ***
Each retort did not have an accurate temperature-recording device. Specifically, ***
There was no means of preventing unauthorized changes in adjustment to the temperature-recording
Thermometers and temperature indicating devices were not tested against a known accurate standard
thermometer [upon installation] [at least once a year] [as frequently as necessary]. Specifically, ***

The differential pressure recorder-controller was not tested [upon installation] [every three months of
operation] [as frequently as necessary] against a known accurate standard pressure indicator.
Specifically, ***
There was no means of preventing unauthorized speed changes to the metering pump. Specifically, ***
The product-sterilizing holding tube [was not designed to prevent heating of the tube between the
product inlet and product outlet] [was not sloped upward at least 0.25 inch per foot]. Specifically, ***
Measurements or observations of the [temperature-indicating device in the holding tube outlet]

[temperature recorder in the holding tube outlet] [temperature recorder-controller at the final heater
outlet] [differential pressure recorder-controller] [product flow rate] [sterile air pressure] [proper
performance of seam seals or similar devices] were not [performed] [recorded] at the start of aseptic
processing to ensure the values were as specified in the scheduled process for aseptic packaging
operations. Specifically, ***
Measurements or observations of the [temperature-indicating device in the holding tube outlet]

[temperature recorder in the holding tube outlet] [temperature recorder-controller at the final heater
outlet] [differential pressure recorder-controller] [product flow rate] [sterile air pressure] [proper
performance of seam seals or similar devices] were not [performed] [recorded] at intervals of sufficient
frequency to ensure the values were as specified in the scheduled process for aseptic packaging
operations. Specifically ***
Methods and controls used for the manufacturing, processing and packaging of thermally processed
foods wherein critical factors such as water activity are used are not operated and administered in a
manner adequate to ensure the product is safe. Specifically, ***
The time and temperature of processing and other critical factors specified in the scheduled process were
not measured with instruments having adequate accuracy or dependability. Specifically, ***
Automatic recording devices were not used to record [sterilization media flow rates] [temperature]
[concentration] [factors specified in the scheduled process] for container sterilizing, filling, and closing
operations. Specifically, ***
Failure to fully reprocess or destroy food where a process deviation has been evaluated as being unsafe.
Specifically, ***
Failure to take adequate care to exclude contamination of food from adverse conditions on bordering
grounds not under your control. Specifically, ***
Ice in contact with food has been made from water which is [unsafe] [of inadequate sanitary quality].
Specifically, ***
Failure to measure can double seam characteristics using a micrometer at three different points
approximately 120 degrees apart, excluding the side seam. Specifically, ***
Failure to maintain records of the results of inspections and tests performed on closing machines.
Specifically, ***
Failure to use procedures recognized by competent processing authorities as being adequate to detect
any potential hazard to public health in the evaluation of a deviation from the scheduled process.
Specifically, ***
Failure to make regular observations for gross closure defects during production runs. Specifically ***
Failure to have heat distribution data on file which demonstrates that adequate venting of air is
accomplished, for retort installations which deviate from the diagrams in [113.40(a)(12)(i)(a)] [113.40(a)
(12)(i)(b)] [113.40(a)(12)(i)(c)] [113.40(a)(12)(i)(d)] [113.40(a)(12)(ii)(a)] [113.40(a)(12)(ii)(b)]. Specifically,
***
Failure to maintain complete records covering all aspects of the establishment of the [process]
[associated incubation tests] by the person or organization making the determination. Specifically, ***
Failure to promptly notify the FDA of any instance of [spoilage] [process deviation] [contamination with
microorganisms] which represents a potential danger to public health, prior to distribution. Specifically,
***
Failure to prepare, review and retain at [the processing plant] [a reasonably accessible location] for three
years all records [of processing] [of deviations in processing] [specified in 21 CFR 114]. Specifically, ***
Failure to notify FDA about [spoilage] [process deviations] of potential public health significance when all
or part of a lot was distributed. Specifically, ***
Failure to notify FDA about any instance of microbiological contamination, which may have caused a lot
to be injurious to health, when all or part of the lot was distributed. Specifically, ***
Failure to prepare and maintain in files current procedures for [recalling products which may be injurious
to health] [identifying, collecting, warehousing and controlling products] [determining effectiveness of
recalls] [notifying FDA] [implementing recall programs]. Specifically, ***
For an intentional change in a previously filed scheduled process, failure to submit to CFSAN, within 30
days after first use, [a complete description of the modifications made and utilized] [a copy of the file
record showing prior substantiation by a qualified scientific authority as to the safety of the changed
process]. Specifically, ***
Failure to maintain all records pertaining to nutrient premix testing. Specifically, ***
You do not have records that [fully] document corrective actions that were taken. Specifically, ***
Your review of critical control point monitoring records does not [ensure that the records are complete]
[verify that they document values that are within critical limits]. Specifically, ***
You do not retain [all of] the required records at your facility for the required time period. Specifically,
***
You did not remedy the presence of unsanitary conditions, scale, residue, or oxidation on a product
water-contact surface by adequate cleaning and sanitizing prior to use. Specifically, ***
You do not take product water samples after processing and prior to bottling. Specifically, ***
You do not analyze product water samples as often as necessary to assure uniformity and effectiveness of
the treatment processes performed by the plant. Specifically, ***
When a teardown examination revealed gross closure defects, [adequate] corrective action was not
taken. Specifically, ***
No report was made of a serious adverse event associated with a dietary supplement marketed in the
United States. Specifically, ***
Copies of labels from on or within the retail package of a dietary supplement did not accompany serious
drug event report. Specifically, ***
You did not [establish] [follow] written procedures for preventing microbial contamination from sick or
infected personnel. Specifically, ***
You did not [establish] [follow] written procedures for hygienic practices. Specifically, ***
Your personnel did not wear outer garments in a manner that protects against contamination of
components, dietary supplements or contact surfaces. Specifically, ***
Your personnel did not maintain adequate cleanliness. Specifically, ***
Your personnel did not thoroughly [wash] [wash and sanitize] their hands in an adequate hand-washing
facility [before starting work] [at any time when the hands may have become soiled or contaminated].
Specifically, ***
Your personnel did not remove unsecured [jewelry] [objects] that might fall into components, dietary
supplements, equipment, or packaging. Specifically, ***
Your personnel stored clothing or other personal belongings in areas where [components, dietary
supplements, or contact surfaces are exposed] [contact surfaces are washed]. Specifically, ***
Your personnel [ate food] [chewed gum] [drank beverages] [used tobacco products] in areas where
components, dietary supplements, or contact surfaces are exposed or where contact surfaces are
washed. Specifically, ***
The personnel you identified to perform quality control operations do not have distinct and separate
responsibilities related to performing such operations from those responsibilities that the personnel
otherwise have when not performing such operations. Specifically, ***
Your training documentation did not include the [date of the training] [type of training] [persons trained].
Specifically, ***
Your bathrooms [were not clean] [were a potential source of contamination to components, dietary
supplements, or contact surfaces]. Specifically, ***
Water that does not become a component of the dietary supplement was not [safe and sanitary] [at
suitable temperature] [under appropriate pressure] for all uses. Specifically, ***
Water that was used a manner such that the water may become a component of a dietary supplement
did not comply with applicable [Federal] [State] [local] requirements. Specifically, ***
You used [insecticides] [fumigants] [fungicides] [rodenticides] without taking precautions to protect
against the contamination of components, dietary supplements, or contact surfaces. Specifically, ***
You did not use sanitizing agents that [are free from microorganisms of public health significance] [are
safe and adequate under the conditions of use]. Specifically, ***
Your physical plant did not have adequate space for the orderly placement of equipment and holding of
materials as necessary [for maintenance, cleaning, and sanitizing operations] [to prevent contamination
and mix-ups of components and dietary supplements]. Specifically, ***
Your [fixtures] [ducts] [pipes] were not designed and constructed so that they do not contaminate of
components, dietary supplements, or contact surfaces by dripping,, leakage, or condensate. Specifically,
***
Your physical plant did not have equipment that controls temperature and humidity when it is necessary
to ensure the quality of the dietary supplement. Specifically, ***
Your physical plant did not permit the use of proper precautions to reduce the potential for mix-ups or
contamination of components, dietary supplements, or contact surfaces, with microorganisms, chemicals,
filth, or other extraneous material. Specifically, ***
You [did not have] [did not use] separate or defined areas of adequate size or other control systems
prevent contamination or mix-ups of components or dietary supplements during holding operations.
Specifically, ***
Your physical plant did not provide adequate light in areas where components or dietary supplements are
[examined] [processed] [held]. Specifically, ***
You did not use safety-type [light bulbs] [fixtures] [skylights] [glass] over exposed components or dietary
You did not have records or copies of records required for your physical plant and grounds readily
available during the required retention period for inspection and copying by FDA when requested.
Specifically, ***
You used equipment or utensils that do not have seams that are smoothly bonded or maintained to
minimize accumulation of extraneous materials or contaminants. Specifically, ***
Your freezer, refrigerator, or other cold storage compartment that you use to hold components or dietary
supplements does not have an indicating thermometer, temperature-measuring device, or temperature-
recording device that indicates and records, or allows for recording by hand, the accurate temperature
within the compartment. Specifically, ***
You did not store cleaned and sanitized utensils that are used to manufacture, package, label, or hold
components or dietary supplements [in a manner] [in a location] that protects them from contamination.
Specifically, ***
Your quality control personnel did not periodically review routine [calibrations] [inspections] [checks] of
your automated, mechanical, or electronic equipment. Specifically, ***
You did not [establish] [use] appropriate controls for automated, mechanical, or electronic equipment to
ensure that changes [are approved by quality control personnel] [are instituted only by authorized
personnel]. Specifically, ***
You did not keep batch production records for the required time period. Specifically, ***
Your batch production records did not include the batch, lot, or control number of each lot of packaged
and labeled dietary supplement from the finished batch of dietary supplement. Specifically, ***
Your batch production records did not include the initials of the person responsible for weighing or
measuring each component used in the batch. Specifically, ***
Your batch production records did not include the initials of the person responsible for adding a
component to the batch. Specifically, ***
Your batch production records did not include the results of any tests or examinations conducted on
packaged and labeled dietary supplements or a cross-reference to the physical location of such results.
Specifically, ***
Your batch production records did not include documentation that quality control personnel reviewed
required monitoring operations. Specifically, ***
Your batch production records did not include documentation [at the time of performance] of a required
material review and disposition decision. Specifically, ***
You did not [establish] [follow] written procedures for the requirements for packaging received.
Specifically, ***
You did not [establish] [follow] written procedures for the requirements for rejected products that are
received for packaging or labeling as a dietary supplement. Specifically, ***
You did not visually examine each immediate container, or grouping of immediate containers in a
shipment, for [appropriate content label] [container damage] [broken seals to determine whether the
container condition may have resulted in contamination or deterioration of the components].
Specifically, ***
Your quality control personnel did not [approve components while the components were quarantined]
[release components from quarantine] for use in the manufacture of a dietary supplement. Specifically,
***
You did not hold components under conditions that will [protect against contamination] [protect against
deterioration] [avoid mix-ups]. Specifically, ***
Your quality control personnel did not approve labels for use in the manufacture of a dietary supplement
and release them from quarantine. Specifically, ***
You did not use a unique identifier whenever you recorded the disposition of each unique lot within each
unique shipment of [packaging] [labels]. Specifically, ***
You did not hold [packaging] [labels] under conditions that will avoid mix-ups. Specifically, ***
You did not visually examine each immediate container, or grouping of immediate containers, in a
shipment of product that you received for packaging or labeling as a dietary supplement for [appropriate
content label] [container damage] [broken seals] to determine whether the container condition may have
resulted in contamination or deterioration of the received product. Specifically, ***
You did not visually examine the supplier's invoice, guarantee, or certification in a shipment of received
product to ensure that the received product was consistent with your purchase order. Specifically, ***
You did not quarantine received product. Specifically, ***

Your quality control personnel did not release received product from quarantine for [packaging] [labeling]
as a dietary supplement. Specifically, ***
You did not identify each unique lot within each unique shipment of received product in a manner that
allows you to trace the lot to [the supplier] [the date received] [the name of the received product] [the
status of the received product] [the product that you packaged or labeled and distributed as a dietary
supplement]. Specifically, ***
You did not use a unique identifier when you recorded the disposition of a unique lot within a unique
shipment of received product. Specifically, ***
You did not keep records required for [components] [packaging] [labels] [product received for packaging
or labeling] for the required time period. Specifically, ***
You did not make and keep written procedures for fulfilling the requirements that apply to components of
dietary supplements. Specifically, ***
You did not make and keep documentation that the requirements that apply to production and process
control for components of dietary supplements were met. Specifically, ***
Your documentation of a required operation did not include the initials of the person performing the
required operation. Specifically, ***
You did not hold reserve samples [under conditions consistent with product labels] [under ordinary
storage conditions]. Specifically, ***
You did not distribute a dietary supplement under conditions that protect the dietary supplement against
contamination and deterioration. Specifically, ***
You did not [establish] [follow] sampling plans for obtaining representative samples of finished batches of
dietary supplements. Specifically, ***
You did not make and keep written procedures for laboratory operations. Specifically, ***
You did not make and keep documentation that established laboratory methodology was followed.
Specifically, ***
The documentation for laboratory tests and examinations did not include the results of the testing and
examination. Specifically, ***
You did not identify [processing lines] [major equipment] used during manufacturing to indicate their
contents. Specifically, ***
You did not segregate and identify containers for a specific batch of dietary supplements to identify their
contents and, when necessary, the phase of manufacturing. Specifically, ***
You did not identify and hold [components] [dietary supplements] for which a material review and
disposition decision is required in a manner that protects [components] [dietary supplements] that are
not under a material review against contamination and mix-ups with those that are under a material
review. Specifically, ***
You did not hold [components] [dietary supplements] that can support the rapid growth of
microorganisms of public health significance in a manner that prevents them from becoming adulterated.
Specifically, ***
You did not use effective means to [remove, destroy, or prevent the growth of microorganisms] [prevent
decomposition]. Specifically, ***
You did not design or select manufacturing processes that ensure that product specifications are
consistently met. Specifically, ***
Your master manufacturing record did not include a complete list of components to be used. Specifically,
***
You did not have records or copies of records required for your master manufacturing records readily
available during the required retention period for inspection and copying by FDA when requested.
Specifically, ***
Your electronic master manufacturing records do not comply with the electronic records requirements.
Specifically, ***
You did not keep a master manufacturing record for the required time period. Specifically, ***
You did not keep the records required for your packaging and labeling operations as original records, true
copies, or as electronic records. Specifically, ***
You did not clearly [identify] [hold] [control] under a quarantine system for appropriate disposition
packaged and labeled dietary supplement rejected for distribution. Specifically, ***
You [repackaged] [relabeled] a dietary supplement before approval by your quality control personnel
Specifically, ***
You did not suitably dispose of labels and packaging for dietary supplements that are obsolete or
incorrect to ensure that they are not used in any future packaging and label operations. Specifically, ***
You did not establish physical or spatial separation of [packaging] [label] operations from operations on
other components and dietary supplements to prevent mix-ups. Specifically, ***
You did not protect manufactured dietary supplements from contamination during [filling] [assembling]
[packaging] [labeling] operations. Specifically, ***
You did not [fill] [assemble] [package] [label] [perform operations related to packaging and labeling] in a
way that ensured that the dietary supplement is packaged and labeled as specified in the master
manufacturing record. Specifically, ***
You did not [fill] [assemble] [package] [label] [perform operations related to packaging and labeling] in a
way that ensured the quality of the dietary supplement. Specifically, ***
Your review and investigation of a product complaint did not extend to all relevant batches and records.
Specifically, ***
The written record of a product complaint did not include the batch, lot, or control number of the dietary
Your production and in-process control system is not designed to ensure that the dietary supplement is
manufactured, packaged, labeled, and held in a manner that will ensure the quality of the dietary
You did not implement quality control operations to ensure that the dietary supplement is [packaged]
[labeled] as specified in the master manufacturing record. Specifically, ***
You did not establish in-process specifications for a point, step, or stage in the master manufacturing
record where control is necessary for limits on contamination that may adulterate or may lead to
adulteration of the finished dietary supplement. Specifically, ***
Your quality control personnel did not review and approve the documentation of your basis for why
meeting the in-process specifications, in combination with meeting component specifications, will help
ensure that the specifications are met for the identity, purity, strength, and composition of the dietary
You did not determine whether you met identity specifications established for components. Specifically,
***
You did not determine whether you met established component specifications established to ensure the
[purity] [strength] [composition] of dietary supplements manufactured using the components.
Specifically, ***
You did not determine whether you met established limits on contamination that may adulterate or may
lead to adulteration of the finished batch of the dietary supplement. Specifically, ***
You did not determine whether you met established limits on contamination that may adulterate, or that
may lead to adulteration of, the finished batch of the dietary supplement. Specifically, ***
The certificate of analysis for a component does not include [a description of the test or examination
method(s) used] [limits of the test or examination] [actual results of the tests or examinations].
Specifically, ***
You did not monitor the in-process points, steps, or stages to detect any deviation or unanticipated
occurrence that may result in a failure to meet specifications. Specifically, ***
Your quality control personnel did not review and approve your documentation of the basis for
determining compliance with [an] established specification[s] for [identity] [purity] [strength]
[composition] [limits on contamination that may adulterate or that may lead to adulteration of the
dietary supplement]. Specifically, ***
You did not document why an exempted product specification is met without verification by periodically
testing the finished batch. Specifically, ***
Your quality control personnel did not review and approve the documentation of why an exempted
product specification is met without verification through periodic testing of the finished batch.
Specifically, ***
You did not conduct a visual examination of the [packaging] [labeling] of the finished [packaged] [labeled]
dietary supplements to determine whether you [used] [applied] the specified label. Specifically, ***
You did not collect representative samples of each unique lot of [components] [packaging] [labels] that
you used to determine whether the [components] [packaging] [labels] meet[s] established specifications.
Specifically, ***
You did not retain reserve samples for the required time. Specifically, ***
You reprocessed a rejected dietary supplement for which quality control personnel did not conduct a
material review and make a disposition decision to approve the reprocessing. Specifically, ***
You did not make and keep documentation for why component and in-process testing, examination,
monitoring or other information will ensure that an exempted product specification is met, without
verification through periodic testing of the finished batch. Specifically, ***
Your quality control personnel did not review and approve the documentation setting forth the basis for
qualification of suppliers. Specifically, ***
why meeting in-process specifications, in combination with meeting component specifications, will help
ensure that the identity, purity, strength, and composition of the dietary supplement are met.
Specifically, ***
why the results of appropriate tests or examinations for each product specification will ensure that the
finished batch of the dietary supplement meets product specifications. Specifically, ***
Your quality control personnel did not ensure that required representative samples are collected.
Specifically, ***
Your quality control personnel did not perform required operations for [components] [packaging] [labels]
before use in the manufacture of a dietary supplement. Specifically, ***
Your quality control personnel did not perform required operations for returned dietary supplements.
Specifically, ***
You do not have quality control operations for laboratory operations associated with the production and
process control system. Specifically, ***
Your quality control personnel did not conduct a material review and make a disposition decision when a
dietary supplement was returned. Specifically, ***
Your quality control personnel did not reject the dietary supplement when there was a deviation or
unanticipated occurrence during the production and in-process control system that [resulted in] [could
lead to] adulteration of the dietary supplement. Specifically, ***
Your quality control operations did not include reviewing and approving all processes for calibrating
instruments and controls. Specifically, ***
Your quality control operations did not include periodically reviewing all records for calibrations,
inspections, or checks of [automated equipment] [mechanical equipment] [electronic equipment].
Specifically, ***
Your quality control operations did not include reviewing and approving controls to ensure that
[automated] [mechanical] [electronic] equipment functions according to [its] [their] intended use.
Specifically, ***
You do not have quality control operations for [components] [packaging] [labels] before use in the
manufacture of a dietary supplement. Specifically, ***
Your quality control operations did not include reviewing and approving all batch production-related
records. Specifically, ***
Your quality control operations for [the master manufacturing record] [the batch production record]
[manufacturing operations] did not include conducting a required material review and making a required
disposition decision. Specifically, ***
Your quality control operations did not include approving or rejecting reprocessing. Specifically, ***
Your quality control personnel approved and released for distribution a batch of dietary supplement for
which one or more components did not meet identity specifications. Specifically, ***
Your quality control personnel approved and released for distribution a batch of dietary supplement that
was not manufactured, packaged, labeled, or held under conditions to prevent adulteration. Specifically,
***
Your quality control personnel approved and released for distribution product received from a supplier
for [labeling] as a dietary supplement for which sufficient assurance was not provided [to adequately
identify the product] [to determine that the product was consistent with your purchase order].
Specifically, ***
Your quality control operations for returned dietary supplements did not include [determining whether a
reprocessed dietary supplement meets product specifications] [either approving for release, or rejecting,
any returned dietary supplement that was reprocessed]. Specifically, ***
Your quality control operations for product complaints did not include [reviewing and approving decisions
about whether to investigate a product complaint] [reviewing and approving the findings and follow-up
action of any investigation performed]. Specifically, ***
You did not keep the records required for your quality control operations as original records, true copies,
or as electronic records. Specifically, ***
Your electronic records for your quality control operations do not comply with the electronic records
requirements. Specifically, ***
You did not make and keep documentation of your material review and disposition decision. Specifically,
***
You did not [establish] [follow] written procedures for when a returned dietary supplement must be
destroyed, or otherwise suitably disposed. Specifically, ***
Your quality control personnel did not approve or reject the release for distribution of a returned dietary
supplement that was reprocessed. Specifically, ***
You did not keep the records required for equipment and utensils for the required time period.
Specifically, ***
You did not make and keep written procedures for [maintaining] [cleaning] [sanitizing] contact surfaces
that are used to manufacture, package, label, or hold components or dietary supplements. Specifically,
***
You did not make and keep written records of calibrations, inspections, or checks of automated,
mechanical, or electronic equipment. Specifically, ***
You did not make and keep backup files of outdated software necessary to retrieve records from the
computer systems that you use to manufacture, package, label, or hold dietary supplements. Specifically,
***
You do not procure chicks from SE-monitored breeder flocks that meet the National Poultry Improvement
Plan's standards for "U.S. S. Enteritidis Clean" or equivalent status. Specifically,***
Eggs intended to be processed as table eggs [were not held and transported as required at or below 45
deg. F] [were held at room temperature for more than 36 hours just prior to processing]. Specifically,***
Environmental testing for SE, using approved methods, was not done in a poultry house containing more
than one group of laying hens, when each group of laying hens was 40 to 45 weeks of age.
Specifically,***
For eggs being diverted to treatment, the statement "Federal law requires that these eggs must be
treated to achieve at least a 5-log destruction of Salmonella Enteritidis or processed as egg products in
accordance with the Egg Products Inspection Act, 21 CFR 118.6(f)" fails to appear [on the pallet, case or
other shipping container] [on all documents accompanying the shipment] [in a legible and conspicuous
manner]. Specifically,***
An environmental test for SE was not done for each poultry house as required. Specifically,***
You do not have one or more supervisory personnel who are responsible for ensuring compliance with
each farm's SE prevention plan. Specifically,***
You lack [qualified] supervisory personnel who are responsible for [development and implementation of
an SE plan that is appropriate for your farm and meets the regulatory requirement] [reassessing and
modifying the SE prevention plan as necessary] [reviewing records created to document the SE
prevention measures]. Specifically, ***
You did not maintain records documenting the results of SE testing. Specifically,***
Your written SE prevention plan was stored offsite. Specifically,***
Your firm did not register your farm(s) with the FDA [within 30 days of becoming an egg producer] [by the
applicable effective date of the regulation (21 CFR Part 118)]. Specifically,***
During a field examination of food products at your facility the following [was] [were] observed:
Frequency
318
300
224
177
171
160
159
157
152
144
140
140
132
132
131
127
125
125
124
122
115
109
107
104
92
90
86
84
84
83
76
76
75
74
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72
71
70
70
68
68
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67
66
66
64
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44
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40
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5
5
4
4
4
4
4
4
3
3
3
3
3
3
3
3
2
2
2
2
2
2
2
2
2
2
2
2
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
Human tissue for 12213 21 CFR 1271.47(a)

transplantation

transplantation

transplantation

transplantation
Human tissue for 12247 21 CFR 1271.55(d)(2)
transplantation
Human tissue for 12277 21 CFR 1271.75(a)(1)
transplantation
Human tissue for 12286 21 CFR 1271.80(b)
transplantation
transplantation
Human tissue for 12431 21 CFR 1271.265(e)

transplantation

transplantation
transplantation
transplantation
transplantation
Human tissue for
transplantation 12351 21 CFR 1271.190(d)(1)

transplantation
Human tissue for 12301 21 CFR 1271.150(c)(1)(iii)

transplantation
Human tissue for 12433 21 CFR 1271.265(f)
transplantation

transplantation

transplantation
Human tissue for 12239 21 CFR 1271.55(b)(2)
transplantation
Human tissue for 12246 21 CFR 1271.55(d)(1)(iii)

transplantation
Human tissue for 12282 21 CFR 1271.75(d)

transplantation
Human tissue for 12287 21 CFR 1271.80(c)

transplantation

transplantation
transplantation
transplantation
transplantation

transplantation

transplantation

transplantation
transplantation
transplantation

transplantation

transplantation
transplantation

transplantation

transplantation

transplantation

transplantation
transplantation

transplantation
Human tissue for 12395 21 CFR 1271.225

transplantation
Human tissue for 12426 21 CFR 1271.265(c)(2)

transplantation

transplantation

transplantation

transplantation

transplantation

transplantation
transplantation

transplantation

transplantation
transplantation
transplantation

transplantation

transplantation
Human tissue for 12370 21 CFR 1271,200(c)

transplantation

transplantation
transplantation

transplantation

transplantation

transplantation

transplantation
Human tissue for

transplantation 12460 21 CFR 1271.320(c)

transplantation

transplantation

transplantation
transplantation
transplantation
transplantation

transplantation

transplantation

transplantation

transplantation

transplantation
transplantation
transplantation
transplantation

transplantation

transplantation
Human tissue for

transplantation 12319 21 CFR 1271.160(b)(3)

transplantation

transplantation

transplantation

transplantation
transplantation

transplantation

transplantation

transplantation
transplantation

transplantation

transplantation
transplantation
transplantation

transplantation

transplantation

transplantation

transplantation
Human tissue for
transplantation 12408 21 CFR 1271.250(c)

transplantation
transplantation
transplantation
transplantation

transplantation
transplantation

transplantation

transplantation

transplantation

transplantation

transplantation

transplantation

transplantation

transplantation
Short Description
Donor eligibility procedures
Procedures for all steps
Procedures to meet core CTGP
Responsible person to determine, document
Accurate, indelible, legible
Risk factors, clinical evidence
Specimen collections not timely
Eligibility not required--warning labels
Procedures and release criteria
Storage temperatures recorded, maintained
Reactive tests--not determined ineligible
Infection with communicable disease agents
Determination based on screening and testing
Procedures for cleaning, sanitation
Abbreviated procedure
Ensurane of compliance
Return to inventory--procedures
Procedures re complaints
Design of procedures to ensure compliance
Listing and interpretation of CD tests performed
Documentation--determination, by whom, date
Donors with risks not determined ineligible
Kits not FDA approved, specifically labeled
Documentation of activities
Aseptic processing---cleaning, disinfecting
Monitoring-microorganisms where appropriate
Validation & approval--established procedures
Contamination, mix ups, improper release
Shipping conditions appropriate
Records maintained concurrently
Accurate, indelible, legible
Review and approval of procedures
Summary--records used to make determination
Name and personal info on accompanying records

Labeled re: biohazard, risks, test results
Actions verified, short and long term solutions
Monitoring systems
Deviations--evaluation, cause, corrective action
Quality audits performed periodically
Trained or re-trained as necessary
Monitoring--cross contamination, exposure to CD
Verification/validation
Improperly released for distribution
Records incomplete
Establishing a system
Donor testing not negative for CD agents
Eligibility statement--basis of determination
Completion of eligibility determination
Manufacturer instructions not followed
Ensuring appropriate core requirements followed
Training of personnel
Documentation/approval prior to implementation
Review and approval-responsible person
Adequate control, proper conditions
Procedures inadequate
Calibration procedures and schedules (general)
Cleaned, sanitized per established schedules
Calibrated per established schedules
Use prior to verification
Causing contamination, increasing risks
Documentation elements for activities
Documenting disposition of each HCT/P
Review and evaluation, report to FDA
Reproductive cells or tissues
SOP for release; reactive for CMV
Documentation of maintenance and cleaning
Reproductive cells or tissues-cell-associated CD

Availability of procedures
Departures: recording and justifying
Donor screening standards
Reasons for ineligibility on summary
Documentation maintained (general)
Information, English or translated-authenticity
Improper release prevention--storage, I.D.
Prominently labeled (limited use)
Risks associated with xenotransplantation
Birth mother sample not tested
Program is appropriate for the HCT/Ps
All core requirements covered in program
Actions taken and documented
Problem description, disposition, date et. al.
Qualifications lacking
Availability of procedures
Adopted from another organization

Size, construction, location--prevent mix-ups etc.
State of repair
Lighting, ventilation, plumbing
Clean, sanitary, orderly manner
Sewage, trash removal
Control system
Temperature and humidity controls
Ventilation and air filtration controls
Corrective actions
In-process HCT/Ps-control
Sampling representative (in-process HCT/Ps)
Process validation procedures
Controlling the labeling of HCT/Ps
All labeling requirements met
Corrective actions
Temperature limits
Periodic review of temperatures
Evaluation--microorganisms, damage
Release criteria verified, documented

Release of HCT/Ps by responsible person
Organized to facilitate review
Recording I.D. code and type of HCT/P
Designated complaint file
Sufficient information to draw conclusions
Reportable events not investigated
Adverse reaction reporting to FDA
Deviations not reported to FDA
Autologous use only--labeling

Long Description
Procedures for all steps performed in the [testing] [screening] [determining] of donor eligibility of HCT/Ps
were not [established] [maintained] [defined] [documented] [implemented] [followed] [reviewed]
[revised]. Specifically, ***
Procedures for all steps performed in the [testing] [screening] [determining] of donor eligibility of HCT/Ps
Procedures appropriate to meet core CGTP requirements for all steps that you perform in the
manufacture of HCT/Ps were not [established] [maintained] [defined] [documented] [implemented]
[followed] [reviewed] [revised]. Specifically, ***
The eligibility of an HCT/P donor was not [determined] [documented] by a responsible person, based on
results of donor screening and donor testing. Specifically, ***
Donor eligibility records are not [accurate] [indelible] [legible]. Specifically, ***
Donors were not screened by a review of relevant medical records for [risk factors] [clinical evidence] of
communicable disease agents and diseases. Specifically, ***
Donor specimens used for testing of communicable disease agents were not collected at the appropriate
time. Specifically, ***
HCT/Ps for which the donor eligibility determination was not performed were not prominently labeled
with the appropriate warning statements. Specifically, ***
Procedures including release criteria for activities relating to the [receipt] [shipment] [distribution] of
HCT/Ps were not [established] [maintained] [documented] [implemented] [followed] [reviewed]
Storage temperatures of HCT/Ps were not [recorded] [maintained]. Specifically, ***
Donors whose specimens test reactive on screening tests for communicable disease agents were not
determined to be ineligible. Specifically, ***
Donors were not tested for evidence of infection with communicable disease agents. Specifically, ***
HCT/P donors were not determined to be eligible based on the results of donor screening and testing.
Specifically, ***
Procedures for facility cleaning and sanitation were not [established] [maintained] [defined]
[documented] [implemented] [followed] [revised]. Specifically, ***
The abbreviated donor screening procedure [was used for donors who had no complete donor screening
procedure in the previous six months] [did not determine and document changes in the donor's medical
history that would make the donor ineligible]. Specifically, ***
You did not ensure that establishment(s) that by contract, agreement or arrangement, perform
manufacturing steps for you were in compliance with [applicable CGTP requirements prior to the
initiation of the contract, agreement of arrangement] [applicable CGTP requirements after information
became available that suggested the establishment was no longer in compliance]. Specifically, ***
Procedures for determining if HCT/Ps that were returned to the establishment are suitable to be returned
to inventory were not [established] [maintained] [defined] [documented] [implemented] [followed]
[reviewed] [revised]. Specifically, ***
Procedures for the [review] [evaluation] [documentation] [investigation] of complaints relating to core
CGTP requirements were not [established] [maintained] [defined] [documented] [implemented]
[followed] [reviewed] [revised]. Specifically, ***
Procedures were not designed to ensure compliance with the donor eligibility requirements. Specifically,
***
The summary of records for HCT/Ps did not contain [a listing] [an interpretation of results] of all
communicable disease tests performed. Specifically, ***
Documentation of [the donor-eligibility determination] [the responsible person who made the donor-
eligibility determination] [the date of the donor-eligibility determination] was not maintained.
Specifically, ***
Donors were not determined to be ineligible that had [risk factors or clinical evidence of communicable
disease agents] [communicable disease risks associated with xenotransplantation]. Specifically, ***
Communicable disease agent tests [were not FDA-licensed, approved or cleared donor screening tests]
[were not specifically labeled for cadaveric specimens when such a test was available and cadaveric
specimens were used]. Specifically, ***
Documentation of facility cleaning and sanitation activities was not maintained. Specifically, ***
Environmental controls do not provide for adequate [cleaning] [disinfecting] of [rooms] [equipment] to
ensure aseptic processing. Specifically, ***
Environmental conditions were not monitored for microorganisms. Specifically, ***
Processes with results which could not be fully verified by inspection and tests, were not validated and
approved according to established procedures. Specifically, ***
Storage areas and stock rooms were not controlled [to prevent mix-ups, contamination and cross
contamination of HCT/Ps, supplies and reagents] [to prevent HCT/Ps from improperly being made
available for distribution]. Specifically, ***
Appropriate shipping conditions were not [established] [maintained] [defined] [documented]

[implemented] [followed] [reviewed] [revised] for each type of HCT/P. Specifically, ***
Records were not maintained concurrently with the performance of each step. Specifically, ***
Records were not [accurate] [indelible] [legible]. Specifically, ***
Donor eligibility procedures were not [reviewed] [approved] by a responsible person before
After completion of the donor-eligibility determination, HCT/Ps were not accompanied with the summary
of the records used to make the donor-eligibility determination. Specifically, ***
The accompanying records for HCT/Ps included [the donor's name] [personal information that might
identify the donor]. Specifically, ***
HCT/Ps from ineligible donors which were made available for limited use were not prominently labeled
with [the Biohazard legend] [a statement warning of communicable disease risks] [a statement warning
of the reactive test results]. Specifically, ***
Corrective actions relating to core CGTP requirements [have not been verified to ensure effectiveness and
compliance with CGTP] [did not include both short term corrective actions to address the immediate
deficiency and long term corrective actions to prevent recurrence]. Specifically, ***
The quality program has not established and maintained appropriate monitoring systems. Specifically,
***
Investigation of deviations related to core CGTP requirements did not include [a review and evaluation of
the deviation] [efforts to determine the cause of the deviation] [corrective action(s) to address the
deviation and prevent recurrence]. Specifically, ***
Periodic quality audits of activities related to core CGTP requirements have not been performed.
Specifically, ***
Personnel have not been [trained] [re-trained as necessary] to adequately perform their assigned
responsibilities. Specifically, ***
Environmental conditions are not monitored when such conditions could cause [contamination or cross
contamination of HCT/Ps or equipment] [the accidental exposure of HCT/Ps to communicable disease
agents]. Specifically, ***
Process changes were not [validated] [verified] to ensure the change does not cause an adverse impact
elsewhere in operations. Specifically, ***
HCT/Ps that were [in quarantine] [contaminated] [recovered from a donor determined to be ineligible]
[recovered from a donor for whom a donor eligibility determination has not been completed]
[determined to not meet release criteria designed to prevent communicable disease transmission] were
made available for distribution. Specifically, ***
Records [did not identify the person performing the work] [did not show the dates of entries] [were not
detailed as necessary to provide a complete history of work performed] [did not relate to the HCT/P
involved]. Specifically, ***
A tracking system that enables the tracking of HCT/Ps back and forth from the donor to the consignee or
final disposition was not [established] [maintained] [defined] [documented] [implemented] [followed]
[reviewed] [revised]. Specifically, ****
Donor testing of HCT/P donors considered eligible was not negative or nonreactive for relevant
communicable disease agents. Specifically, ***
After the completion of the donor-eligibility determination, HCT/Ps were not accompanied with a
statement whether the donor has been determined to be eligible or ineligible, based on the results of
screening and testing. Specifically, ***
HCT/Ps were not kept in quarantine until completion of the donor-eligibility determination. Specifically,
***
Testing for communicable disease agents was not performed in accordance with the manufacturer's
instructions. Specifically, ***
The quality program has not ensured that appropriate procedures related to core CGTP requirements
were [established] [maintained] [defined] [documented] [implemented] [followed] [reviewed]
[approved] [revised]. Specifically, ***
The quality program has not ensured the proper training and education of personnel involved in core GTP
activities. Specifically, ***
Computer software [validation] [verification] activities and results have not been [documented]
[approved] prior to implementation. Specifically, ***
Procedures for core CGTP requirements were not [reviewed] [approved] by a responsible person before
Environmental conditions existed in which [contamination or cross contamination of HCT/Ps or

equipment] [the accidental exposure of HCT/Ps to communicable disease agents] could occur, and
[environmental conditions were not adequately controlled] [proper conditions for operations were not
provided]. Specifically, ***
Procedures for the [cleaning] [sanitizing] [maintenance] of equipment were not [established]
[maintained] [defined] [documented] [implemented] [followed] [revised]. Specifically, ***
The [procedures] [schedules] for the calibration of equipment used for [inspection] [measuring] [testing]
Equipment used for manufacturing HCT/Ps was not [cleaned] [sanitized] [maintained] according to
established schedules. Specifically, ***
Equipment used for [inspection] [measuring] [testing] was not calibrated according to established
schedules. Specifically, ***
Supplies and reagents were used before they were verified to meet specifications designed to prevent the
introduction, transmission, or spread of communicable disease. Specifically, ***
HCT/Ps were not processed in a way [that does not cause contamination or cross contamination during
processing] [that does not increase the risk of introduction, transmission, or spread of communicable
disease]. Specifically, ***
Documentation for activities related to the [receipt] [shipment] [distribution] of HCT/Ps did not include
[identification of the HCT/P and the establishment that supplied the HCT/P] [activities performed and the
results of each activity] [date(s) of activity] [quantity of HCT/P subject to the activity] [disposition of the
HCT/P (identity of consignee)]. Specifically, ***
A method has not been [established] [maintained] [defined] [documented] [implemented] [followed]
[reviewed] [revised] in the tracking system [to document the disposition of each HCT/P] [to permit the
prompt identification of the consignee of the HCT/P, if any]. Specifically, ***
Complaints were not reviewed and evaluated to determine [if the complaint is related to an HCT/P
deviation or adverse reaction] [whether a report to FDA is required]. Specifically, ***
Donors of reproductive cells or tissues not recovered by a method that ensures freedom from
contamination were not tested for communicable diseases of the genitourinary tract. Specifically, ***
A standard operating procedure for the release of HCT/Ps from donors that test reactive for
cytomegalovirus (CMV) was not [established] [maintained] [defined] [documented] [implemented]
[followed] [reviewed] [revised]. Specifically. ***
Documentation of equipment maintenance, cleaning, sanitization, and calibration was not maintained.
Specifically, ***
Donors of viable, leukocyte-rich reproductive cells or tissues were not tested for cell-associated
communicable diseases or cytomegalovirus (CMV). Specifically, ***
Donor eligibility procedures were not available to personnel in the area where operations are performed,
or in a nearby area when such availability is impractical. Specifically, ***
Departures from donor eligibility procedures relevant to preventing risks of communicable disease
transmission were not [recorded] [justified]. Specifically, ***
Donor screening of HCT/P donors considered eligible indicated that the donor was not free of [risk factors
for infection due to communicable disease agents] [clinical evidence of infection due to communicable
disease agents] [risk factors associated with xenotransplantation]. Specifically, ***
The summary of records for HCT/Ps from donors determined to be ineligible based on screening and
released for limited use did not contain a statement noting the reasons(s) for the ineligibility. Specifically,
***
Documentation was not maintained after the donor-eligibility determination was complete. Specifically,
***
Information on [the identity] [the relevant medical records] of donors of HCT/Ps were [not in English] [not
retained and translated to English] [not accompanied by a statement of authenticity by the translator that
specifically identifies the translated document]. Specifically, ***
HCT/Ps from ineligible donors are not [stored] [identified] in a manner to prevent improper release.
Specifically, ***
HCT/Ps from ineligible donors which were made available for limited use were not prominently labeled.
Specifically, ***
Donors were not screened by a review of relevant medical records for disease risks associated with
xenotransplantation. Specifically, ***
A sample from the birth mother of a donor one month of age or younger was not used for testing of
communicable disease agents. Specifically, ***
A quality program appropriate for the HCT/Ps manufactured and manufacturing steps performed has not
been [established] [maintained] [defined] [documented] [implemented] [followed] [reviewed] [revised].
Specifically, ***
A quality program which addresses all of the core CGTP requirements, appropriate for the HCT/Ps
manufactured and the manufacturing steps performed, has not been [established] [maintained] [defined]
[documented] [implemented] [followed] [reviewed] [revised]. Specifically, ***
The quality program has not ensured that appropriate corrective actions relating to core CGTP
requirements are [taken] [documented]. Specifically, ***
Documentation of corrective actions did not include [a description of the HCT/Ps] [the disposition] [the
nature of the problem] [the description of the corrective action] [the date of the corrective action].
Specifically, ***
Personnel do not have the necessary [education] [experience] [training] to ensure competent
performance of their assigned functions. Specifically, ***
Procedures for core CTGP requirements were not available to personnel in the area where operations are
performed, or in a nearby area when such availability is impractical. Specifically, ***
Current standard procedures adopted from another organization were [not verified to be consistent with
the requirements of the CGTP regulations] [not appropriate for your operations]. Specifically, ***
Facilities were not of suitable [size] [construction] [location] to [prevent contamination of HCT/Ps with
communicable disease agents] [ensure the orderly handling of HCT/Ps without mix-ups]. Specifically, ***
Facilities were not maintained in a good state of repair. Specifically, ***
Facilities did not provide adequate [lighting] [ventilation] [plumbing] [drainage] [access to sinks and
toilets] to prevent the introduction, transmission or spread of communicable disease. Specifically, ***
Facilities were not maintained in a [clean] [sanitary] [orderly] manner to prevent the introduction,
transmission, or spread of communicable disease. Specifically, ***
Removal of [sewage] [trash or other refuse] was not done in a timely, safe and sanitary manner.
Specifically, ***
Operations were not controlled with a system [established] [maintained] [defined] [documented]
[implemented] [followed] [reviewed] [revised] to prevent [improper labeling] [mix-ups] [contamination]
[cross contamination] [accidental exposure of HCT/Ps to communicable disease agents]. Specifically, ***
Environmental controls do not provide for adequate control of [temperature] [humidity]. Specifically, ***
Environmental controls do not provide for adequate [ventilation] [air filtration]. Specifically, ***
Appropriate corrective actions were not taken related to the inspections of environmental control
systems. Specifically, ***
In-process HCT/Ps were not controlled until [required inspections, tests, or other verification activities
were completed] [necessary approvals were received and documented]. Specifically, ***
Sampling of in-process HCT/Ps was not representative of the material to be evaluated. Specifically, ***
Procedures to validate and approve processes that cannot be fully verified by inspection and tests were
not [established] [maintained] [defined] [documented] [implemented] [followed] [reviewed] [revised].
Specifically, ***
Procedures to control the labeling of HCT/Ps were not [established] [maintained] [defined] [documented]
[implemented] [followed] [reviewed] [revised]. Specifically, ***
Labeling procedures did not ensure that HCT/Ps are labeled in accordance with all labeling requirements.
Specifically, ***
Corrective actions were not [performed] [documented] when proper storage conditions were not met.
Specifically, ***
Acceptable temperature limits were not established for the storage of HCT/Ps at each step of the
manufacturing process to inhibit the growth of infectious agents. Specifically, ***
Recorded storage temperatures were not periodically reviewed to ensure that temperatures have been
within acceptable limits. Specifically, ***
Incoming HCT/Ps were [not evaluated for the presence and significance of microorganisms] [not
inspected for damage and contamination]. Specifically, ***
Release criteria were not [verified] [documented] to have been met through a review of manufacturing
and tracking records before HCT/Ps were made available for distribution. Specifically, ***
A responsible person did not [document] [date] the determination that an HCT/P is available for
distribution. Specifically, ***
The records management system did not maintain records to facilitate review of particular HCT/Ps history
[prior to becoming available for distribution] [subsequent to release as part of a follow-up evaluation or
investigation]. Specifically, ***
A method has not been [established] [maintained] [defined] [documented] [implemented] [followed]
[reviewed] [revised] in the tracking system to record [the distinct identification code] [the type] of each
HCT/P distributed to a consignee. Specifically, ***
Complaints received were not maintained in a file designated for complaints. Specifically, ***
The complaint file [did not contain sufficient information about each complaint for proper review and
evaluation] [did not include the distinct identification code of the HCT/P involved] [did not contain
sufficient information for determining whether the complaint is an isolated event or represents a trend].
Specifically, ***
Complaints that represent events required to be reported to FDA were not [reviewed] [evaluated]
[investigated]. Specifically, ***
Adverse reactions which involved a communicable disease related to an HCT/P made available for
distribution and were fatal or life threatening, resulted in permanent impairment or damage to the body,
or necessitated medical or surgical intervention, were not reported to FDA. Specifically, ***
HCT/P deviations relating to core CGTP requirements that occurred [in your establishment] [at an
establishment under contract, agreement, or arrangement with your establishment] were not reported to
FDA. Specifically, ***
HCT/Ps for autologous use and for which the donor eligibility determination was not performed were not
labeled for autologous use only. Specifically, ***
Frequency
24
19
17
15
13
12
11
11
10
5
5
3
3
2
2
2
1
1
1
1
1
1
Parts 1240 and 1250 7036 21 CFR 1250.67
Parts 1240 and 1250 7032 21 CFR 1250.63
Parts 1240 and 1250 6560 21 CFR 1250.32(a)
Parts 1240 and 1250 6558 21 CFR 1250.30(d)
Parts 1240 and 1250 6552 21 CFR 1250.28
Parts 1240 and 1250 6581 21 CFR 1250.38(b)
Parts 1240 and 1250 6570 21 CFR 1250.33(c)
Parts 1240 and 1250 6580 21 CFR 1250.38(b)
Parts 1240 and 1250 6555 21 CFR 1250.30(a)
Parts 1240 and 1250 6564 21 CFR 1250.33(a)
Parts 1240 and 1250 6569 21 CFR 1250.33(b)

Parts 1240 and 1250 6612 21 CFR 1250.50
Parts 1240 and 1250 7089 21 CFR 1250.82(d)
Parts 1240 and 1250 7090 21 CFR 1250.82(e)
Parts 1240 and 1250 6549 21 CFR 1250.27
Parts 1240 and 1250 6554 21 CFR 1250.30(a)
Parts 1240 and 1250 6561 21 CFR 1250.32(b)
Parts 1240 and 1250 6563 21 CFR 1250.33(a)
Parts 1240 and 1250 6572 21 CFR 1250.34
Parts 1240 and 1250 6609 21 CFR 1250.49
Parts 1240 and 1250 7030 21 CFR 1250.62
Parts 1240 and 1250 7034 21 CFR 1250.65

Parts 1240 and 1250 7041 21 CFR 1250.70(a)
Parts 1240 and 1250 7042 21 CFR 1250.70(a)
Parts 1240 and 1250 7053 21 CFR 1250.75(b)
Parts 1240 and 1250 7055 21 CFR 1250.75(b)
Parts 1240 and 1250 7081 21 CFR 1250.82(a)
Parts 1240 and 1250 6567 21 CFR 1250.33(b)
Parts 1240 and 1250 6579 21 CFR 1250.38(a)
Parts 1240 and 1250 6582 21 CFR 1250.38(c)

Parts 1240 and 1250 6585 21 CFR 1250.39
Parts 1240 and 1250 6590 21 CFR 1250.42(a)
Parts 1240 and 1250 6591 21 CFR 1250.42(a)
Parts 1240 and 1250 7038 21 CFR 1250.67
Parts 1240 and 1250 7051 21 CFR 1250.75(a)
Parts 1240 and 1250 7054 21 CFR 1250.75(b)
Parts 1240 and 1250 7087 21 CFR 1250.82(c)

Short Description
Prevention of the spread of communicable diseases
Contamination
Plumbing design, installation, maintenance
Handling to avoid contamination
Soap, sanitary towels, water
Storage and handling after bactericidal treatment
Signs
Clean and free from flies, rodents, and other vermin
Maintained in good repair
Equipment kept clean

Designed to permit ready cleaning
Identification marks on tanks and piping
Backflow prevention - general
Storage of perishables
Ventilation and lighting
Clean hands
Easily cleaned, self-draining
Thermometers
Clean and free of flies and mosquitoes
Submittal of construction plans
Pooling
Adequate and readily accessible
Clean and sanitary
Sanitary sewers or alternative methods
Equipment for cleaning and flushing
Separate systems
Cleaning of multiuse eating and drinking utensils
Suitable design and construction
Maintained in clean condition

Containers - close-fitting covers
Complete and closed
Backflow protection
Signs for non-potable water
Contamination of passenger stations
Soil cans and removable containers
Potable water tanks -- openings

Long Description
Failure to [design] [construct] [maintain] [operate] servicing area [piping systems] [hydrants] [taps]
[faucets] [hoses] [buckets] [equipment] in such a manner as to prevent contamination of [drinking]
[culinary] water. Specifically, ***
Servicing area are not [provided with all necessary sanitary facilities] [operated] [maintained] as to
prevent the spread of communicable diseases. Specifically, ***
Not all food-handling operations are accomplished so as to minimize the possibility of contaminating
[food] [drink] [utensils]. Specifically, ***
Plumbing is not [designed] [installed] [maintained] so as to prevent contamination of [the water supply]
[food] [food utensils]. Specifically, ***
Ice coming into contact with [food] [drink] is not [handled] [stored] in such a manner as to avoid
Hand washing facilities for use by food-handling employees lack [soap] [sanitary towels] [hot and cold
running water]. Specifically, ***
Failure to [store] [handle] utensils, after bactericidal treatment, in such a manner as to prevent
contamination before reuse. Specifically, ***
Signs directing food-handling employees to wash their hands after each use of toilet facilities are not
[posted] [readily observable by such employees]. Specifically, ***
Not all [kitchens] [galleys] [pantries] [places] where food is prepared, served, or stored are [clean] [free
from flies, rodents, and other vermin]. Specifically, ***
Not all [utensils] [working surfaces] used in connection with [preparation] [storage] [serving] of [food]
[beverages] are maintained in good repair. Specifically, ***
Failure to keep all equipment clean. Specifically, ***
Lack of design of [toilet] [lavatory] facilities so as to permit ready cleaning. Specifically, ***
Not all [tanks] [piping] bear clear marks of identification. Specifically, ***
Lack of backflow prevention in the installation of [pipes] [fittings] conveying potable water to [fixtures]
[apparatus] [equipment]. Specifically, ***
Failure to keep perishable [food] [drink] at or below 50 degrees Fahrenheit except when being prepared
or kept hot for serving. Specifically, ***
Not all [kitchens] [galleys] [pantries] [places] where food is prepared, served, or stored are adequately
[lighted] [ventilated]. Specifically, ***
Persons with unclean hands were engaged in handling [food] [drink] [utensils] [equipment]. Specifically,
***
Not all [utensils] [working surfaces] used in connection with [preparation] [storage] [serving] of [food]
[beverages] are constructed so as to be [easily cleaned] [self-draining]. Specifically, ***
Failure to equip each refrigerator with a thermometer located in the warmest region thereof. Specifically,
***
Not all conveyances were kept [clean] [free of flies and mosquitoes] while in transit. Specifically, ***
Failure to submit plans for the [construction] [major reconstruction] of sanitation facilities at servicing
areas to FDA for review. Specifically, ***
Drainage at places where water or food supplies are loaded into or removed from conveyances is
inadequate to prevent pooling. Specifically, ***
Adequate [toilet] [washroom] [locker] [essential sanitary] facilities for use of employees are not readily
accessible adjacent to [places] [areas] where [land] [air] conveyances are [serviced] [maintained]
[cleaned]. Specifically, ***
Failure to maintain [toilet] [washroom] [locker] [essential sanitary] facilities for use of employees in a
clean and sanitary condition. Specifically, ***
Failure to dispose of toilet wastes through [sanitary sewers] [methods assuring sanitary disposal].
Specifically, ***
Equipment for [cleaning soil cans and removable containers] [flushing nonremovable containers and
waste carts] is [not designed so as to prevent backflow into the water line] [used for a purpose connected
with the handling of food, water, or ice]. Specifically, ***
The potable water system is [not separate and distinct from other water systems] [used for other
purposes]. Specifically, ***
Failure to [thoroughly clean in warm water] [subject to an effective bactericidal treatment] multiuse
eating and drinking utensils after each use. Specifically, ***
Failure to provide [toilet] [lavatory] facilities of suitable design and construction for use by food-handling
employees. Specifically, ***
Failure to maintain toilet rooms in a clean condition. Specifically, ***
Garbage containers lack close-fitting covers. Specifically, ***
A water system which is not [complete] [closed] from the filling ends to the discharge taps (except for
protected vent openings). Specifically, ***
A water system not protected against backflow. Specifically, ***
Outlets for non-potable water are not posted with [permanent] signs warning that the water is unfit for
drinking. Specifically, ***
Failure to dispose of human wastes in such a manner as to avoid contamination of passenger [areas]
[stations]. Specifically, ***
Failure to [thoroughly] clean [soil cans] [removable containers] prior to return to use. Specifically, ***
A potable water tank is equipped with a [manhole] [overflow] [vent] [device for measuring depth of
water] and [no] [inadequate] provision is made to prevent entrance into the tank of contaminating
substances. Specifically, ***
Frequency
55
21
13
11
10
5
4
4
2
2
1
1
1
Radiological health 5007 21 CFR 1002.13
Radiological health 5203 21 CFR 1040.10(h)(2)(i)
Radiological health 5032 21 CFR 1010.2(b)
Radiological health 5031 21 CFR 1010.2(a)
Radiological health 5173 21 CFR 1040.10(g)(5)(i)
Radiological health 5189 21 CFR 1040.10(g)(7)(v)
Radiological health 5202 21 CFR 1040.10(h)(1)(vi)

Radiological health 5207 21 CFR 1040.11(a)(1)
Radiological health 5670 21 CFR 1040.10(h)(2)(ii)
Radiological health 5013 21 CFR 1003.10(b)
Radiological health 5034 21 CFR 1010.2(c)
Radiological health 5099 21 CFR 1020.40(c)(8)(i)

Radiological health 5142 21 CFR 1040.10(e)(2)
Radiological health 5143 21 CFR 1040.10(f)(1)
Radiological health 5144 21 CFR 1040.10(f)(2)(i)
Radiological health 5168 21 CFR 1040.10(g)(2)(i)
Radiological health 5171 21 CFR 1040.10(g)(3)
Radiological health 5174 21 CFR 1040.10(g)(5)(ii)
Radiological health 5181 21 CFR 1040.10(g)(6)(v)
Radiological health 5195 21 CFR 1040.10(g)(10)

Radiological health 5197 21 CFR 1040.10(h)(1)(i)
Radiological health 5199 21 CFR 1040.10(h)(1)(iii)
Radiological health 5200 21 CFR 1040.10(h)(1)(iv)
Radiological health 5244 21 CFR 1040.20(f)
Radiological health 5472 21 CFR 1020.30(k)
Radiological health 5687 21 CFR 1002.10(j)
Radiological health 5688 21 CFR 1002.10(i)
Radiological health 5904 21 CFR 1020.30(c)
Radiological health 5907 21 CFR 1020.30(d)(1)

Radiological health 5910 21 CFR 1020.30(h)(1)(ii)
Short Description
Failure to submit
Reproduction of affixed information
Failure to submit, distinct marking
Certification label or tag
Lack of certification of conformance
Failure to submit
Failure to report
FDA not notified of defect or noncompliance
ID label or tag
Aperture label - laser radiation
DIPH label wording - Class IV
50 mm classification warning
Med. laser compliance, measurement
Aperture label
Reproductions of warnings
Forwarding, holding, preserving distribution data
Lack of required elements
Not submitted prior to introduction
Dealers, distributors, purchasers not notified
CAP not submitted
Certification not based on adequate test/testing

program
ID label lacks name and address
ID label lacks place, month & year of manufacture
Warning labels for controls

Compliance test conditions
Protective housing
Safety interlock not provided
Class IIIa "Caution" label
Class IV "Danger" label
Aperture label wording - collateral EM radiation
NIPH label wording - Class IV
Labels legible, visible, permanent

User information, adequate instructions
Legible reproductions
User info - list controls, etc.
Calibration of measurement system
Test deficiencies
Compliance measurements--diagnostic source

assembly
Warning signs, labels, instructions
Results of testing and quality control procedures
Five year requirement
Quality control procedures
Results of tests
Assembly instructions of components adequate
Report of assembly submitted within 15 days

Maintenance schedule (all x-ray eqpt)
Long Description
You did not submit an annual report [by the September 1 deadline] for products requiring one.
Specifically, ***
The manufacturer did not provide or cause to be provided in all [catalogs] [specification sheets]
[descriptive brochures] pertaining to each laser product, a legible reproduction of [the class designation]
[the warning] [the information required for positions 1, 2, and 3 of the applicable logotype] required b to
be affixed to the product. Specifically, ***
You did not submit a required product report [distinctly marked "Radiation Safety Product Report of (your
name)"] prior to the introduction of the product into commerce. Specifically, ***
A certification label or tag is not [in the English language] [permanently affixed or inscribed] [legible]
[readily accessible to view when the product is fully assembled for use]. Specifically, ***
Failure to furnish to the [dealer] [distributor], at the time of delivery of a product, a certification that the
product conforms to all applicable standards. Specifically, ***
You did not submit a required supplemental report, prior to the introduction of the product into
commerce, for a new or modified model within a model or chassis family. Specifically, ***
You did not immediately report to the Director, CDRH, FDA, an accidental radiation occurrence reported
to or otherwise known to you. involving a product introduced or intended to be introduced into
commerce by you. Specifically, ***
You did not notify the Secretary, in accordance with 21 CFR 1003.20, of an electronic product which [was
defective] [failed to comply with an applicable Federal standard] which you [produced] [assembled]
[imported] [distributed]. Specifically, ***
An identification label or tag is not [in the English language] [permanently affixed or inscribed] [legible]
[readily accessible to view when the product is fully assembled for use]. Specifically, ***
The warning statement "AVOID EXPOSURE---Laser radiation is emitted from this aperture" was not affixed
in close proximity to each aperture through which is emitted accessible laser or collateral radiation in
excess of the accessible emission limits of Class I and table VI of Section 1040.10(d). Specifically, ***
Labels regarding Class IV accessible laser radiation which [are visible on the product prior to and during
interlock defeat] [are in close proximity to the opening created by the removal or displacement of such
portion of the protective housing] [include the wording: "DANGER --- Laser radiation when open and
interlock defeated. AVOID EYE OR SKIN EXPOSURE TO DIRECT OR SCATTERED RADIATION."] were not
provided for defeatably interlocked protective housings. Specifically, ***
The following warning was not included in the user information: "CAUTION --- The use of optical
instruments with this product will increase eye hazard", when use of a 50 millimeter diameter aperture
stop in a laser product classified with a 7 millimeter diameter aperture stop resulted in a higher
classification of the product. Specifically, ***
The medical laser product [fails to comply with all of the applicable requirements of Sec. 1040.10 for
laser products of its class.] [does not incorporate in each Class III or IV medical laser product a means for
the measurement of the level of that laser radiation intended for irradiation of the human body, having
an error in measurement of no more than 20% when calibrated in accordance with the CFR
requirements]. Specifically, ***
A label bearing the wording: "Laser aperture". is not affixed to the medical laser product, in close
proximity to the aperture through which was emitted accessible laser radiation in excess of the accessible
emission limits of Class I. Specifically, ***
Adequate instructions for service adjustments and service procedures were not provided or caused to be
provided for each laser model, including legible reproductions of required labels and hazard warnings.
Specifically, ***
You have not [immediately] forwarded to the manufacturer all of the distribution information which you
have collected pursuant to 21 CFR 1002.40, nor have you elected (in writing to the manufacturer) to hold
and preserve that information. Specifically, ***
An annual report which you submitted did not [summarize the contents of the records required by 21 CFR
1002.30(a)] [provide the volume of products produced, sold, or installed] [cover the 12-month period
ending on June 30 preceding the due date of the report]. Specifically, ***
You did not submit an abbreviated report, required by 21 CFR 1002.1, prior to introduction of the
You did not notify [all of] the [dealers] [distributors] [purchasers] [subsequent transferees] of an
electronic product which [was defective] [failed to comply with an applicable Federal standard] .
Specifically, ***
In a situation where an electronic product you have manufactured [fails to comply with an applicable
Federal standard] [has a defect subject to the notification requirements of 21 CFR 1003.10(b)], you have
not submitted a plan to the Secretary to [bring the product into conformity with the standard] [remedy
the defect] without charge (including reimbursement of any transportation expenses), replace the
product with a like or equivalent one which [complies with the standard] [is free of defects relating to
safety of its use], or refund the cost of the product to the purchaser. Specifically, ***
Certification was not based upon [a test, in accordance with the standard] [a testing program in
accordance with good manufacturing practices]. Specifically, ***
An identification label failed to provide the name and address of the [manufacturer] [individual or
company under whose name the product was sold]. Specifically, ***
An identification label fails to provide the [place] [month] [year] of manufacture. Specifically, ***
A cabinet x-ray system lacks a clearly legible and visible label, permanently affixed or inscribed at the
location of each control which can be used to initiate x-ray production, bearing the statement: "Caution:
X-Rays Produced When Energized." Specifically, ***
Testing for compliance was not done during operation, maintenance, or service [under those conditions
and procedures which maximize the accessible emission levels, including start-up, stabilized emission,
and shut-down of the laser product] [with all controls and adjustments listed in the operation,
maintenance, and service instructions adjusted in combination to result in the maximum accessible
emission level of radiation] [at points in space to which human access is possible in the product
configuration which is necessary to determine compliance with each requirement] [with the measuring
instrument detector so positioned and so oriented with respect to the laser product as to result in the
maximum detection of radiation by the instrument] [for a laser product other than a laser system, with
the laser coupled to that type of laser energy source which is specified as compatible by the laser product
manufacturer and which produces the maximum emission level of accessible radiation from that
product]. Specifically, ***
Each laser product is not provided with a protective housing that prevents human access during
operations to laser and collateral radiation that exceeds the limits of Class I and table VI, respectively,
wherever and whenever such human access is not necessary for the product to perform its intended
function(s). Specifically, ***
Each laser product was not provided with at least one safety interlock for each portion of the protective
housing which is designed to be removed or displaced during operation or maintenance, when such
removal or displacement permitted human access to laser or collateral radiation in excess of the
accessible emission limits of Class I and table VI. Specifically, ***
Each Class IIIa laser product with an irradiance less than or equal to 2.5x10-3 W cm2 does not have
affixed a label [bearing the warning logotype specified in the regulation] [the wording "LASER RADIATION
--- DO NOT STARE INTO BEAM OR VIEW DIRECTLY WITH OPTICAL INSTRUMENTS" in the position specified
by the regulation] [the wording "CLASS IIIa LASER PRODUCT" in the position specified in the regulation].
Specifically, ***
Each Class IV laser product does not have affixed a label [bearing the DANGER logotype specified in the
regulation] [bearing the wording "LASER RADIATION--AVOID EYE OR SKIN EXPOSURE TO DIRECT OR
SCATTERED RADIATION" in the position specified in the regulation] [bearing the wording "CLASS IV LASER
PRODUCT" in the position specified in the regulation]. Specifically, ***
The following label on the laser product was not affixed in close proximity to each aperture through
which is emitted accessible collateral radiation in excess of the accessible emission limits of Class I and
table VI of Section 1040.10(d): "AVOID EXPOSURE --- Hazardous electromagnetic radiation is emitted
from this aperture". Specifically, ***
Labels for Class IV accessible laser radiation which [are visible on the protective housing prior to
displacement or removal of such portions of the protective housing] [are visible on the product in close
proximity to the opening created by removal or displacement of such portions of the protective housing]
[include the wording: "DANGER --- Laser radiation when open. AVOID EYE OR SKIN EXPOSURE TO DIRECT
OR SCATTERED RADIATION."] were not provided for noninterlocked protective housings. Specifically, ***
Labels which are legible and clearly visible during operation, maintenance, or service are not
permanently affixed to or inscribed on laser products. Specifically, ***
Adequate instructions for each laser product were not provided or caused to be provided for [assembly]
[operation] [maintenance] [clear warnings concerning precautions to avoid possible exposure to laser and
collateral radiation in excess of the accessible emission limits specified in the regulations] [a maintenance
schedule necessary to keep the product in compliance with the standard]. Specifically, ***
Legible reproductions of all labels and hazard warnings required by the regulations [were not affixed to
the laser product] [were not provided with the laser product] [did not include the information required
for positions 1, 2, and 3 of the logotype specified in the CFR]. Specifically, ***
The manufacturer did not provide or cause to be provided a listing of [all controls] [all adjustments] [all
procedures for operation and maintenance] [the warning: "Caution --- use of controls or adjustments or
performance of procedures other than those specified herein may result in hazardous radiation
exposure."]. Specifically, ***
The Class [III] [IV] medical laser product is not supplied with instructions specifying a procedure and
schedule for calibration of the measurement system. Specifically, ***
The certification tests [did not account for all errors and statistical uncertainties in the process] [did not
account for changes in radiation emission or degradation in radiation safety with the age of the product].
[Failure to make measurements for certification purposes under those operational conditions, lamp
voltage, current, and position as recommended by the manufacturer.] [Failure to position the measuring
instrument at the recommended exposure position and so oriented as to result in the maximum
detection of the radiation by the instrument.] Specifically, ***
Compliance for radiation leakage from the diagnostic source assembly was not determined by
measurements averaged over an area of 100 square centimeters with no linear dimension greater than
20 centimeters. Specifically, ***
A product report did not describe for each model all [warning signs] [labels] [instructions for installation,
operation, and use] that relate to electronic product radiation safety. Specifically, ***
A product report did not provide sufficient results of testing, measuring, and quality control procedures
to enable FDA to determine the effectiveness of those methods and procedures. Specifically, ***
You have not preserved your required record(s) for a period of five years from the date of the record.
Specifically, ***
You have not [established] [maintained] records containing a description of quality control procedures
with respect to electronic product radiation safety. Specifically, ***
You have not [established] [maintained] records of the results of tests for electronic product radiation
safety, including the control of unnecessary, secondary or leakage electronic product radiation.
Specifically, ***
The manufacturer's assembly instructions were not [provided] [adequate to assure compliance] for
components installed into a diagnostic x-ray system. Specifically, ***
A completed report of assembly regarding certified components installed in a diagnostic x-ray system was
not submitted to [the Director, CDRH] [the purchaser] [the State agency responsible for radiation
protection] within 15 days following the completion of the assembly. Specifically, ***
Manuals or instruction sheets which include a schedule of the maintenance necessary to keep the
equipment in compliance with the regulations were not provided to [purchasers] [persons other than
purchasers, upon request, at a cost not to exceed the cost of publication and distribution]. Specifically,
***
Frequency
11
2
2
1
1
1
1
1
1
Veterinary medicine 4185 FDCA 402(a)(4)
Veterinary medicine 4093 21 CFR 530.11(d)
Veterinary medicine 4298 21 CFR 530.11(a)
Veterinary medicine 4097 21 CFR 530.20(a)(2)(iv)

Veterinary medicine 4094 21 CFR 530.11(b)
Veterinary medicine 4099 21 CFR 530.20(a)(2)(ii)
Veterinary medicine 4098 21 CFR 530.20(a)(2)(i)
Veterinary medicine 2097 21 CFR 225.102(b)(4)
Veterinary medicine 4111 21 CFR 530.12(c)
Veterinary medicine 4131 21 CFR 589.2000(c)(1)(i)
Veterinary medicine 4132 21 CFR 589.2000(d)(1)
Veterinary medicine 4100 21 CFR 530.20(a)(2)(iii)
Veterinary medicine 4545 21 CFR 225.120
Veterinary medicine 13567 21 CFR 589.2001(c)(2)(iv)

Veterinary medicine 4147 21 CFR 589.2000(e)(1)
Veterinary medicine 4542 21 CFR 225.102((a)
Veterinary medicine 13568 21 CFR 589.2001(c)(2)(v)

Veterinary medicine 13565 21 CFR 589.2001(c)(2)(ii)
Veterinary medicine 1765 21 CFR 225.42(b)(6)(i) - (v)

Veterinary medicine 2093 21 CFR 225.102(b)(2)(i)-(iv)
Veterinary medicine 4101 21 CFR 530.20(a)(1)
Veterinary medicine 4113 21 CFR 530.12(e)
Veterinary medicine 4137 21 CFR 589.2000(d)(1)

Veterinary medicine 13531 21 CFR 511.1(b)(7)(iii)
Veterinary medicine 13532 21 CFR 511.1(b)(7)(ii)
Veterinary medicine 13558 21 CFR 589.2001(c)(1)
Veterinary medicine 13566 21 CFR 589.2001(c)(2)(iii)
Veterinary medicine 13569 21 CFR 589.2001(c)(2)(vi)


Short Description
Record keeping
Tissue residue
Drug inventory
Expired drugs
Extra label use w/o veterinary client-patient

relationship
Identity of animals
Rx not followed
Records review prior to slaughter
Tissue residue
Drugs prohibited for extralabel use in food producing

animal
Dosage level
Medication status of animals
System for administration of drugs
Species or class
Conditions of use
Hospital pen
Feeding colostrum
Route of administration
Use in animal feed
Extended withdrawal period
Frequency and duration
Withdrawal period
Assay results out of specification
Diagnosis and evaluation of conditions
Daily review of production records
Directions for use
Renderers
Protein blenders, feed manufacturers, distributors
Pest access minimized
Lot number or shipment I.D. number
Identity of treated animals
Vermin and pest infestation
Label "Do not feed to animals"
Integrity and identity

Elements of receipt record
Daily comparison, actual vs theoretical
Discrepancies
Three assays per year
Elements of the MRF
Written product separation procedures
Lack of Production Record(s)
Establishment and use of adequate procedures
Use of veterinary prescription drugs without a

prescription
Marking with readily detected agent
Maintained in clean and orderly condition
Capability to produce a medicated feed
Maintaining proofread label
Preparation of MRF
Maintaining records of complaints
Adequate procedures for Type A and Type B articles
Packaged Type A and Type B designated areas
Investigation and corrective action
Renderer's maintaining adequate written procedures
Maintenance reasonably clean & orderly
Calibration of scales and metering devices
Storage of packaged drugs
Daily inventory record kept
Information required
First batch assay
Alternate testing of drugs in combination
Reasonable and effective procedures followed
Complete Bulk Labeling
Lack of MRF
Elements of production record(s)
Discrepancies investigated, reported
Distribution record elements
Lighting, ventilation, screening, dust, temperature
Specifications, test procedures - Type A medicated

articles
Container receipt, identification, storage, and handling
Distribution despite discrepancies in yield
Approved drug available
Name and address - drug dispensed by veterinarian
Cautionary statements
Withdrawal, withholding, or discard time
Maintaining records
Use of clean-out procedures
Written clean-out procedures

Label stock review
Components uniformly dispersed and stable
Frequency of administration
Employees lack understanding
Adequate procedures established
Scales and metering devices
Bulk Type A and Type B storage
Use in accord with directions
Records kept for one year
Assuring correct labels are used
Bagged or bulk deliveries
Reports: Adequate and Timely
Records: Test article accountability
Cattle 30 months and older used in feed
Exclude entire carcass not inspected and passed
Cross contamination of cattle materials
Tracking records: establish, maintain, make available

Records:establish, maintain, make available
Records about firms supplying segregated cattle

materials
Long Description
Treatment records were not [maintained] [complete]. Specifically,***
Causing a residue of an approved human or animal drug above an established safe level, safe
concentration, or tolerance, through use of the drug contrary to its labeling. Specifically, ***
You lack an adequate inventory system for determining the quantities of drugs used to medicate your
[cows] [calves] [livestock]. Specifically, ***
Expired drug(s) were observed in the drug storage area. Specifically, ***
Use of [a human] [an animal] drug in a manner contrary to label directions without benefit of a valid
veterinary client-patient relationship. Specifically, ***
Failure to [identify] [maintain records regarding the identity of] [record the existing identification of] the
animal(s) that you [purchased] [transported] and delivered for [sale] [consignment] at [an auction yard]
[a slaughter plant]. Specifically, ***
Failure to follow your veterinarian's prescription for [dosage] [frequency and duration of treatment]
[route of administration] [species or class of animal] [pre-slaughter withdrawal time] [special cautionary
directions]. Specifically, ***
Failure to systematically review treatment records prior to offering an animal for slaughter for human
food, to assure that drugs have been used only as directed and that appropriate withdrawal times have
been observed. Specifically, ***
Causing an illegal residue in a food-producing animal of an approved human or animal drug through
[prescribing the use of] [using] the drug contrary to its labeling, and failing to take appropriate measures
to assure that [assigned timeframes for withdrawal were met] [no illegal residue would occur].
Specifically, ***
A prohibited [drug] [substance] was administered in an extralabel manner to [a] food-producing

animal(s). Specifically, ***
Administration of an approved animal drug in excess of the indicated dosage, without benefit of a valid
veterinarian-client-patient relationship. Specifically, ***
Failure to inquire about the medication status of the animal(s) that you [transported] [purchased] and
delivered for [sale] [consignment] at [an auction yard] [a slaughter plant]. Specifically, ***
Failure to have a system to control administration of drug treatments to your animals. Specifically, ***
Administration of an approved human or animal drug to a [species of animal] [class of animal] for which
the drug was not labeled, without benefit of a valid veterinarian-client-patient relationship. Specifically,
***
Administration of a drug for conditions not [specified in its labeling] [prescribed]. Specifically, ***
Failure to [identify] [segregate] [quarantine] treated animals. Specifically, ***
Feeding colostrum or milk from treated cows to calves intended for slaughter. Specifically, ***
Administration of an approved animal drug via a route, [oral] [intramuscular] [intravenous]
[subcutaneous] [topical] [intramammary] [intrauterine], which was not indicated in the labeling, without
benefit of a valid veterinarian-client-patient relationship. Specifically, ***
An approved drug was used in or on an animal feed in a manner not in accordance with the approved
labeling. Specifically, ***
A substantially extended withdrawal period, supported by appropriate scientific information, was not
established for the use of an approved drug in a food-producing animal, in an extralabel manner.
Specifically, ***
Administration of an approved animal drug [more frequently] [for a longer time period] than specified in
the labeling, without benefit of a valid veterinarian-client-patient relationship. Specifically, ***
Administration of an approved animal drug contrary to the labeling, without benefit of a valid
veterinarian-client-patient relationship, in that pre-slaughter withdrawal time was not observed.
Specifically, ***
Failure to [investigate] [implement corrective action] [maintain a record on the premises of corrective
action] when assay results show medicated feeds [not in accord with label specifications] [not within
permissible assay limits]. Specifically,***
Failure to make a careful diagnosis and evaluation of the conditions for which an approved human or
animal drug was to be used in a food-producing animal, contrary to the drug's labeling. Specifically, ***
The batch production records are not checked by a responsible individual at the end of the working day
to determine whether all required production steps have been performed. Specifically, ***
Failure to provide labeling containing directions for use as specified by the veterinarian for a human or
animal drug prescribed for use in an animal contrary to the drug's labeling. Specifically, ***
Products that contain or may contain prohibited material fail to bear a label containing the caution
statement, "Do not feed to cattle or other ruminants." Specifically, ***
Products that contain or may contain prohibited material fail to bear the caution statement, "Do not feed
to cattle or other ruminants." Specifically, ***
The building is not constructed to minimize access by [rodents] [birds] [insects] [pests]. Specifically, ***
The daily inventory records for drugs do not include [the manufacturer's lot number] [the feed
manufacturer's shipment identification number]. Specifically, ***
Failure to assure that the identity of a food-producing animal was maintained, where you had prescribed
or dispensed an approved human or animal drug contrary to the drug's labeling. Specifically, ***
Buildings and grounds are not constructed and maintained in a manner to minimize vermin and pest
infestation. Specifically, ***
Failure to conspicuously label [cattle materials prohibited in animal feed] [products that contain or may
contain cattle materials prohibited in animal feed] with the statement "Do not feed to animals".
Specifically,***
Failure to properly [identify] [store] [handle] [control] drugs in the mixing areas to maintain their integrity
and identity. Specifically, ***
Drug receipt records do not accurately indicate the [identity] [quantity] [name of the supplier] [supplier's
lot number or other identifying number] [date of receipt] [condition of the drug when received] [return
of any damaged drugs] for each lot of drug received. Specifically, ***
A daily comparison is not made between the actual amount of drug used and the theoretical amount of
drug to be used in terms of the [semiprocessed] [intermediate] [finished] medicated feeds manufactured.
Specifically, ***
Failure to [investigate] [take corrective action for] a significant discrepancy between actual drug usage
and theoretical drug usage. Specifically, ***
Periodic assays are not performed during the calendar year on at least three representative samples of
medicated feeds requiring a medicated feed mill license, for each drug or drug combination used.
Specifically, ***
The Master Record File does not contain [the name of the medicated feed] [the name and weight
percentage or measure of each drug or drug combination and each nondrug ingredient to be used in
manufacturing a stated weight of medicated feed] [a copy or description of the label that will accompany
the medicated feed] [manufacturing instructions or reference thereto that have been determined to yield
a properly mixed medicated feed of the specified formula for each medicated feed produced]
[appropriate control directions including the collection of samples for specified laboratory assays] [the
basis for estimating quantity produced, where actual yield cannot be accurately determined when
finished feed is stored in bulk]. Specifically, ***
Failure to maintain procedures for separating products which may contain protein derived from
mammalian tissues from all other protein products, from the time of receipt until the time of shipment.
Specifically, ***
Failure to have production record(s) for specific products which include the complete history of each
batch or production run. Specifically, ***
Adequate procedures are not [established] [used] for all equipment used in the production and
distribution of medicated feeds to avoid unsafe contamination of medicated [and nonmedicated] feeds.
Specifically, ***
Administration of veterinary prescription drugs was performed without the lawful written or oral order of
a licensed veterinarian. Specifically, ***
Failure to mark [cattle materials prohibited in animal feed] [products that contain or may contain cattle
materials prohibited in animal feed] with an agent that can be readily detected on visual inspection.
Specifically,***
Buildings are not maintained in a reasonably clean and orderly manner. Specifically, ***
Equipment does not possess the capability to produce a medicated feed of intended [potency] [safety]
[purity]. Specifically, ***
Proofread labels are not [initialed and dated by a responsible individual] [kept for one year after all the
labels from that batch have been used]. Specifically, ***
A Master Record File providing the complete procedure for manufacturing a specific product is not
[prepared] [checked] [dated] [signed or initialed] by a qualified person. Specifically, ***
The original or copy of a record of each oral or written complaint received relating to the safety and
effectiveness of the product produced is not maintained on the premises. Specifically, ***
Adequate procedures are not [established] [maintained] for the [identification] [storage] [inventory
control (receipt and use)] of all Type A medicated articles and Type B medicated feeds intended for use in
the manufacture of medicated feeds. Specifically, ***
The [packaged Type A medicated articles] [packaged Type B medicated feed] are not [stored in
designated areas] [stored in their original closed containers]. Specifically, ***
Results of laboratory assays of drug components indicated that medicated feed was not in accord with
the permissible limits, and no [investigation] [corrective action] was implemented immediately.
Specifically, ***
Failure to maintain adequate written procedures specifying how the process of [removing the brain and
spinal cord from cattle not inspected and passed for human consumption] [separating animals based on
whether or not they are 30 months of age or older] is carried out. Specifically,***
Equipment is not maintained in a reasonably clean and orderly manner. Specifically, ***
Failure to calibrate scales and metering devices [upon installation] [at least once a year after installation]
[as frequently as necessary] to insure their accuracy. Specifically, ***
Packaged drugs are not stored in their original closed containers. Specifically, ***
Failure to maintain a daily inventory record for each drug used in the manufacture of medicated feeds.
Specifically, ***
Daily inventory records for each drug used do not include [the quantity of drug on hand at the beginning
and end of the work day] [the amount of each drug used, sold, or otherwise disposed of] [the batches or
production runs of medicated feed in which each drug was used] [information concerning any
semiprocessed intermediate mix to be used in a medicated feed] [the action taken to reconcile any
discrepancies in the inventory record]. Specifically, ***
No assay was performed on the first batch for the calendar year of medicated feed requiring a medicated
feed mill license. Specifically, ***
Where only one drug is assayed in a medicated feed containing a combination of drugs, there was a
failure to test a different drug from the one(s) previously tested during the calendar year. Specifically,***
All equipment that comes in contact with [active drug components] [feeds in process] [finished
medicated feed] is not subject to all reasonable and effective procedures to prevent unsafe
contamination of manufactured feed. Specifically, ***
Where medicated feeds are distributed in bulk, complete labeling [does not accompany the shipment] [is
not supplied the consignee at the time of delivery]. Specifically, ***
Failure to have a Master Record File for manufacturing a specific product, which provides the complete
procedure for manufacturing a specific product. Specifically, ***
Production record(s) fail to include [the product identification] [the date of production] [a written
endorsement in the form of a signature or initials by a responsible individual] [the quantity and name of
drug components used] [the theoretical quantity of medicated feed to be produced] [the actual quantity
of the medicated feed produced] [an estimate of the quantity to be produced and stored in bulk, based
on the basis for the estimate in the MRF]. Specifically, ***
When significant discrepancies were noted on the batch production records, there was a failure to
[institute an investigation immediately] [describe the corrective action taken on the production record].
Specifically, ***
Distribution record(s) for medicated feeds fail to include the [date of shipment] [name and address of
purchaser] [quantity shipped] [name of the medicated feed] [lot, control number, date of manufacture,
or other suitable identification]. Specifically, ***
Buildings used for the [production] [packaging] [labeling] [holding] of Type A medicated articles do not
provide adequate [lighting] [ventilation] [screening] [dust control] [temperature control] to avoid
contamination of such articles. Specifically, ***
Laboratory controls do not include [the establishment of adequate specifications] [a description of

laboratory test procedures to check specifications] to assure that Type A medicated articles conform to
appropriate specifications. Specifically, ***
Containers to be used for [undiluted drugs] [drug components] [intermediate mixtures] [Type A
medicated articles] are not [received] [adequately identified] [properly stored] [handled] in a manner to
avoid mix-ups and contamination. Specifically, ***
Key personnel did not prevent distribution of a batch [and other associated batches] of a Type A
medicated article where significant discrepancies were found when checking the actual against
theoretical yield of the batch. Specifically, ***
Failure to determine that an approved animal drug was clinically ineffective for its intended use in a food-
producing animal, prior to prescribing or dispensing an approved human or animal drug contrary to the
drug's labeling. Specifically, ***
Failure to provide labeling showing the name and address of the prescribing veterinarian for a human or
animal drug prescribed for use in an animal contrary to the drug's labeling. Specifically, ***
Failure to provide labeling containing cautionary statements as specified by the veterinarian for a human
or animal drug prescribed for use in an animal contrary to the drug's labeling. Specifically, ***
Failure to provide labeling containing [withdrawal] [withholding] [discard] time as specified by the
veterinarian for a human or animal drug prescribed for use in an animal contrary to the drug's labeling.
Specifically, ***
Receipt of materials that contain or may contain protein derived from mammalian tissues, and failure to
maintain records sufficient to track the materials throughout their receipt, processing, and distribution.
Specifically, ***
Failure to use clean-out procedures or other means adequate to prevent carryover of protein derived
from mammalian tissues to animal protein or feeds that may be used for ruminants. Specifically, ***
Failure to maintain written clean-out procedures to prevent carryover of protein derived from
mammalian tissues to animal protein or feeds that may be used for ruminants. Specifically, ***
Label stock is not [reviewed periodically] [discarded when discontinued labels are found]. Specifically,
***
No determination has been made that the drug components remain uniformly dispersed and stable in
Type A medicated articles under ordinary conditions of shipment, storage and use. Specifically, ***
Administration of a drug [over a longer time period] [more frequently] than [specified in its labeling]
[prescribed]. Specifically, ***
All employees involved in the manufacture of medicated feeds do not have an understanding of the
[manufacturing or control operations they perform] [location and proper use of equipment]. Specifically,
***
Adequate procedures are not established for the [receipt] [storage] [inventory control] of all drugs to aid
in assuring their identity, strength, quality and purity when incorporated into products. Specifically, ***
The [scales] [liquid metering devices] are not of suitable [size] [design] [construction] [precision]
[accuracy] for their intended purpose. Specifically, ***
Bulk [Type A medicated articles] [Type B medicated feeds] are not identified and stored in a manner such
that their identity, strength, quality and purity will be maintained. Specifically, ***
All [Type A medicated articles] [Type B medicated feeds] are not used in accordance with their labeled
mixing directions. Specifically, ***
Records of [investigation] [corrective action] with respect to assays of drug components not meeting
permissible levels are not maintained on the premises for a period of one year. Specifically, ***
Labels are not [received] [handled] [stored] in a manner that [prevents label mix-ups] [assures that the
correct labels are used for the medicated feed]. Specifically, ***
All deliveries of medicated feeds, whether bagged or in bulk, are not adequately labeled to assure that
the feed can be properly used. Specifically, ***
The investigator did not furnish adequate and timely reports of the investigation to the sponsor.
Specifically, ***
Complete records of the receipt and disposition of each shipment or delivery of the test article were not
maintained by the investigator. Specifically, ***
Animal feed or feed ingredients are manufactured from, processed with, or otherwise contain material
prohibited material from cattle not inspected and passed for human consumption that are 30 months of
age or older and from which brains and spinal cords were not [effectively removed] [effectively excluded].
Specifically,***
Failure to exclude from use in animal food the entire carcass of cattle not inspected and passed for
human consumption when the brain and spinal cord are not effectively removed and such cattle are 30
months of age or older. Specifically,***
Failure to provide for measures to avoid cross-contamination by use of [separate equipment] [separate
containers] once cattle materials prohibited in animal feed have been separated from other cattle
materials. Specifically,***
Failure to [establish] [maintain] [make available to FDA for inspection and copying] records that are
sufficient to track cattle materials prohibited in animal feed to ensure such material is not introduced into
animal feed. Specifically,***
Failure to [establish] [maintain] [make available to FDA for inspection and copying] records that are
sufficient to demonstrate that material rendered for use in animal feed was not manufactured from,
processed with, or does not otherwise contain, cattle materials prohibited in animal feed. Specifically,***
With respect to cattle materials obtained from establishments which have segregated cattle materials
prohibited in animal feed, there is a failure to [establish] [maintain] [make available to FDA] records
demonstrating that such establishments have adequate procedures in place to effectively exclude cattle
materials prohibited in animal feed. Specifically,***
Frequency
213
138
64
45
39
33
29
27
26
24
23
23
22
21
18
17
14
12
12
12
10
10
3
3
2
2
1
1
1
1
1
1

Inspections Observations FY13 (FINAL)

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Inspections Observations FY13 (FINAL)

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Number of 483 issued from the System*

Inspections ending between 10/1/2012 12:00:00 AM and 9/30/2013 12:00:00 AM

Center Name 483 issued

Sum Product Area 483s from System* 5211

Actual Total in system 483s** 5050

Biologics 76 21 CFR 606.100(b)

Biologics 98 21 CFR 606.100(c)

Biologics 160 21 CFR 606.160(a)(1)

Biologics 154 21 CFR 606.160(a)(1)

Biologics 155 21 CFR 606.160(b)

Biologics 9225 21 CFR 606.171

Biologics 4425 21 CFR 606.60(a)

Biologics 15030 21 CFR 606.60(b)

Biologics 78 21 CFR 606.100(c)

Biologics 94 21 CFR 606.100(b)(15)

Biologics 41 21 CFR 606.40(a)(1)

Biologics 57 21 CFR 606.60(a)

Biologics 67 21 CFR 606.65(e)

Biologics 255 21 CFR 640.31

Biologics 9243 21 CFR 630.6(a)

Biologics 12202 21 CFR 606.170(a)

Biologics 12203 21 CFR 606.170(a)

Biologics 208 21 CFR 640.3(a)(1)

Biologics 35 21 CFR 606.40

Biologics 9044 21 CFR 600.10(b)

Biologics 61 21 CFR 606.60(a)

Biologics 159 21 CFR 606.160(a)(1)

Biologics 224 21 CFR 640.4(f)

Biologics 246 21 CFR 640.25(a)

Biologics 9097 21 CFR 600.15

Biologics 9236 21 CFR 630.6(b)(1)

Biologics 77 21 CFR 606.100(b)

Biologics 88 21 CFR 606.100(b)(9)

Biologics 89 21 CFR 606.100(b)(10)

Biologics 142 21 CFR 606.140(a)

Biologics 143 21 CFR 606.140(b)

Biologics 144 21 CFR 606.140(c)

Biologics 150 21 CFR 606.151(e)

Biologics 165 21 CFR 606.170(a)

Biologics 167 21 CFR 606.170(b)

Biologics 205 21 CFR 640.3(f)

Biologics 207 21 CFR 640.3(a)

Biologics 225 21 CFR 640.4(f)

Biologics 9086 21 CFR 600.14(a)(1)

Biologics 9087 21 CFR 600.14(a)(1)

Biologics 9089 21 CFR 600.14(c)

Biologics 9093 21 CFR 600.80(b)

Biologics 9234 21 CFR 630.6(c)

Biologics 9235 21 CFR 630.6(c)

Biologics 9596 21 CFR 640.3(a)

Biologics 15036 21 CFR 610.47(a)(1)(B)

Biologics 15044 21 CFR 610.47(b)(3)

Biologics 15075 21 CFR 610.46(b)(3)

Biologics 42 21 CFR 606.40(a)(2)

Biologics 51 21 CFR 606.40(c)

Biologics 63 21 CFR 606.65

Biologics 86 21 CFR 606.100(b)(7)

Biologics 87 21 CFR 606.100(b)(8)

Biologics 91 21 CFR 606.100(b)(12)

Biologics 93 21 CFR 606.100(b)(14)

Biologics 110 21 CFR 606.120(b)(2)

Biologics 123 21 CFR 606.121(c)(4)

Biologics 129 21 CFR 606.121(c)(8)