1412015

WarningLetters>PhilipsMedicalSystems(Cleveland)Inc6/7/11

Home Inspections, Compliance, Enforcement, and Criminal Investigations Compliance Actions and Activities Warning Letters

Inspections,Compliance,Enforcement,andCriminalInvestigations
PhilipsMedicalSystems(Cleveland)Inc6/7/11

DepartmentofHealthandHumanServices

PublicHealthService
FoodandDrugAdministration
CincinnatiDistrictOffice
CentralRegion
6751StegerDrive
Cincinnati,OH4523730977
Telephone:(513)6792700
FAX:(513)6792761

June7,2011

VIAUNITEDPARCELSERVICE

WARNINGLETTERCIN1115899319

JonathanJ.Mazelsky
Sr.V.P.andGMofCT/NM
PhilipsMedicalSystems(Cleveland)Inc.
595MinorRoad
Cleveland,OH441432131

DearMr.Mazelsky:

DuringaninspectionofyourfirmlocatedinCleveland,OHonAugust25,2010throughDecember3,2010,investigatorsfromthe
UnitedStatesFoodandDrugAdministration(FDA)determinedthatyourfirmmanufacturesBrilliance,BigBore,iCT,andtheMX
16SliceFamiliesofCTproductsandGemini,GeminiLXL/TF,BrightView,JetStream,andPrecedenceFamiliesofNM
products.Undersection201(h)oftheFederalFood,Drug,andCosmeticAct(theAct),21U.S.C.321(h),theseproductsare
devicesbecausetheyareintendedforuseinthediagnosisofdiseaseorotherconditionsorinthecure,mitigation,treatment,or
preventionofdisease,orareintendedtoaffectthestructureorfunctionofthebody.

Thisinspectionrevealedthatthesedevicesareadulteratedwithinthemeaningofsection501(h)oftheAct(21U.S.C.351(h)),
inthatthemethodsusedin,orthefacilitiesorcontrolsusedfor,theirmanufacture,packing,storage,orinstallationarenotin
conformitywiththeCurrentGoodManufacturingPractice(CGMP)requirementsoftheQualitySystem(QS)regulationfoundat
Title21,CodeofFederalRegulations(CFR),Part820.WereceivedresponsesfromJosephA.Vinhais,SeniorDirectorCT/NM
QualityandRegulatorydatedDecember23,2010,February28,2011,andMarch31,2011concerningourinvestigators
observationsnotedontheFormFDA483,ListofInspectionalObservationsthatwasissuedtoyou.Weaddresstheseresponses
below,inrelationtoeachofthenotedviolations.Theseviolationsinclude,butarenotlimitedto,thefollowing:

1.Failuretoadequatelyestablishandmaintainproceduresforimplementingcorrectiveandpreventiveaction,asrequired
by21CFR820.100(a).

Forexample,defectCTUDT00184880wasinitiatedon11/18/09,duetothewrongHCORScalingforInfantbasicbodyscans
onaBrilliance64system.Yourfirmidentifiedahazardofmisdiagnosisasan"Unacceptable"risklevel.Theerrorwas
identifiedwhenupdatingfromtheBrilliance2.4.6softwarepackagetoBrilliance2.6softwareatthreebetasites.The
identifiedsolutionwastorecalibratewithaninfantphantomon11/26/09.ThisissuewasnotmanagedthroughtheCAPA
systembutratherthroughtheDefect.TheDefectreportshowsthatthiscorrectiveactionofrecalibratingthesiteswas
"verified"on2/22/10.Yourfirmdidnotimplementthefixuntil3/2/10atonebetasiteand7/8/10(nearly8monthslater)at
another.

Wehavereviewedyourresponsesandhaveconcludedthattheadequacyoftheresponsescannotbedeterminedatthistime.Your
firmhasperformedariskassessmentoftheFieldChangeOrder(FCO72800521)thatresultedfromthecorrectiveaction
mentionedintheobservationusingtheHealthHazardEvaluation(HHE)processanddeterminedtherisktobeunacceptable.Your
firmfiledaFieldActionDecisionForm(FADF)withtheFDAtocorrecttheobservation.Yourfirmhasidentifiedthesystemicroot
causeoftheobservationtobetiedtoExternalValidationprocess.Assuch,yourfirmisrevisingtheExternalValidationprocessto
clearlydefinetherequirementsforExternalValidationactivitiesfromstarttofinish.Inaddition,yourfirmhasidentifiedaspartof
yourcorrectiveaction,theneedforassessingworkinstructions,aligningofvariousqualitysystemprocesses,theassessmentof
openandclosedvalidationrecords,developmentofinstructorleadtraining,andareviewofExternalValidationprocessIT
tools.Yourfirmhasprovidedacorrectiontotheobservationandhasidentifiedthesystemicdeficiencythatresultedinthe
observation.Theplannedrevisions,however,havenotbeenfullycommunicatedorapprovedthroughyourfirmsapprovalprocess
andtheimplementationoftherequiredchangesandtraininghasnotbeenperformed.

2.Failuretoadequatelyimplementandrecordchangesinmethodsandproceduresneededtocorrectandpreventidentified
qualityproblems,asrequiredby21CFR820.100(a)(5).
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm258307.htm

1/10

1412015

WarningLetters>PhilipsMedicalSystems(Cleveland)Inc6/7/11

Forexample,twocomplaints(292365and329346)werefiledatyourfirmrelatedtosmokeoverafourmonthperiod
regardingfireand/oraburningelectricalsmellemittingfromAnode/CathodepowermodulesasaresultofEMIboard
failuresduetomoistureingress.Complaint292365resultedinthefilingofanMDRon11/3/09.Theanode/cathodepower
modulesaresuppliedtoyourfirmby(b)(4).Yoursupplieridentifiedinamemodated2/5/10,thatDIwaterusedtowash
theprintedcircuitboardsmayhavecausedtheissue(moistureingress).Yoursupplier'smanufacturingsolutionwasto
introduceabakingprocesstoremovethemoisture,whichwasimplementedon2/18/10.Yourfirmreceivedthefirst
correctedanode/cathodepowermoduleson2/26/10andtheywereconsumedinproductionby3/11/10.Between2/5/2010
through3/11/2010yourfirmcontinuedtouse264anode/cathodepowermoduleswithunbakedboardswithnodocumented
rationalforcontinuingtouseEMIboardsafterrootcausewasdeterminedandacorrectionimplemented.

Wehavereviewedyourresponsesandhaveconcludedthattheadequacyoftheresponsescannotbedeterminedatthistime.Your
firmhasperformedareviewoffailuresassociatedwiththeAnodePowerModule(APM)andCathodePowerModule(CPM)that
weredistributeddespitetheidentifiedmoistureingressissueandfoundatotalof5complaintsoutof9000unitsinthefield
relatedtotheAPM,CPM,orEMIboards.CAPA#486261wasopenedtoconfirmthatnoadditionalfieldactionwasrequired.No
additionalactionhasbeenidentifiedtodate.YourfirmsinvestigationidentifiedthattheCAPAprocesslackedacompleteand
consistentmethodforCAPAdatasourceidentificationandmethodology,evaluationofnonconformitieswithinCAPAsubsystems,
rootcauseinvestigation,CAPAplanningandimplementationandCAPAeffectivenessmeasures.Yourfirmsactionplanincludes
revisionoftheCAPAprocedureincludingimplementationofaCAPAreviewboard,alignmentofCAPAprocessandinterdependent
processes,implementationofaCAPAassessmenttool,developmentofremediationprotocolforopenandclosedCAPArecords,
developingandconductinginstructorbasedtrainingonrevisedprocesses,andreviewandalignmentofCAPAITtools.Theplanned
revisions,however,havenotbeenfullycommunicatedorapprovedthroughyourfirmsapprovalprocessandtheimplementation
oftherequiredchangesandtraininghasnotbeenperformed.

3.Failuretoinvestigatethecauseofnonconformitiesrelatingtoproduct,process,andthequalitysystem,asrequiredby21
CFR820.100(a)(2).

Forexample,CAPA10020wasissuedon7/30/10regardingbuttonartifactsassociatedwiththreerecentcomplaints
(CTCPa00003315,CTCPa00003468,andPRID:284825).ThisissuewasidentifiedinapreviousCAPA(IR03106dated
11/30/07)whichresultedinafieldcorrection.Todatetherehasbeennodocumentationregardingtheinvestigationora
determinationofrootcause.

Wehavereviewedyourresponsesandhaveconcludedthattheadequacyoftheresponsescannotbedeterminedatthistime.Your
firmhasperformedareviewofthethreecomplaints(CTCPa00003315,CTCPa00003468,andPRID:284825)anddeterminedthat
thecomplaintswerenotrelatedtothepreviousCAPAthatdrovethefieldcorrection.Assuch,yourfirmhasupdatedCAPA10020
toincludeanexplanationofCAPAissuancedocumenttheresultsoftheinvestigationandsubsequentclosure.Yourfirms
investigationidentifiedthattheCAPAprocesslackedacompleteandconsistentmethodforCAPAdatasourceidentificationand
methodology,evaluationofnonconformitieswithinCAPAsubsystems,rootcauseinvestigation,CAPAplanningandimplementation
andCAPAeffectivenessmeasures.YourfirmsactionplanincludesrevisionoftheCAPAprocedureincludingimplementationofa
CAPAreviewboard,alignmentofCAPAprocessandinterdependentprocesses,implementationofaCAPAassessmenttool,
developmentofremediationprotocolforopenandclosedCAPArecords,developingandconductinginstructorbasedtrainingon
revisedprocesses,andreviewandalignmentofCAPAITtools.Theplannedrevisions,however,havenotbeenfullycommunicated
orapprovedthroughyourfirmsapprovalprocessandtheimplementationoftherequiredchangesandtraininghasnotbeen
performed.

4.Failuretoestablishandmaintainadequateprocedurestoverifythedesignofthedeviceinordertoensurethatdesign
outputmeetsthedesigninputrequirementsspecified,asrequiredby21CFR820.30(f).

Forexample,areviewof23designinputsassociatedwiththeCondorCT/PETsystem,(CondorCustomerRequirements
SpecificationRev.F,dated08/24/09)showedthat5ofthedesigninputseitherdidnotmeetspecification,werenot
adequatelytested,ordidnotshowquantifiableresults.
RequirementGEMCR1332identifiesthatthelatencyofrespiratorytagsregistration(latencyinthecorrelationofeventdata
withtherespiratorytriggers)shallbenolongerthan(b)(4).Thisparameterwasnotmet,astheanalysisforRespiratory
TagLatency(XNGV0380058)identifiesalimitof(b)(4),nodocumentationexiststoexplainwhythisisacceptable.
RequirementGEMCR1661identifiesthatthereconstructiontimesonPETimagesshallbelessthan10minutes.TheCondor
reconstructionprotocolverificationtest(VERTC4010)showstimesthatwouldindicatethesystemoriginallyfailedthetest
on4/6/09withatotaltime(b)(4)foraparameterlimitedat(b)(4).PerDesignVerificationValidationprocedureBLSOP
043Rev00,thetestshouldhavebeenmarkedfailedandadefectreportopenedandidentifiedonthetestsheet.Thiswas
notdone.Thetestwasrerunandwasmarkedaspassedlaterthatdaywithnoexplanationofwhythetestfailedorwhat
waschangedtomakethetestpass.
RequirementGEMCR18identifiesthesystembeabletoreconstructPETimageswithareconstructedfieldofviewofatleast
(b)(4).PerVALTC917theOperatorActionsarelistedasrunning"generalsystem"protocols(XNGN0370406/XNGN
0370377)forthetest.TheactualtestonlyranaCondorspecificprotocol(XNGN0370630)andmarkedthetestaspassed.
RequirementGEMCR457identifiesthatwhenthesystemisinaclosedconfigurationthePETandCTcomponentsbe
separatedbyatleast(b)(4).ThiswasmarkedaspassedinVERTC2391andVALTC1439withnorecordedvalue.
RequirementGEMCR495identifiesthatthegatingschemeperformoverarangeof(b)(4).Thisvalidationtestwasnever
conductedasthistest(VALTC1463)wasassociatedwithapreviousfailedverificationtest(VERTC3890).VERTC3890failed
duetomissingconnectersrequiredtotestthesystem,thiswascapturedbydefectreportNMDBa00027439.Thedefect
reportonlyaddressedthemissingconnectorsandtheirinstallation,notthetestingorretestingofthesystem.Thereisno
explanationhowthistest(VALTC2463)passed.
Wehavereviewedyourresponsesandhaveconcludedthattheadequacyoftheresponsescannotbedeterminedatthistime.Your
firmhasperformedareviewofthenonconformitiesandyourfirmdeterminedthatneithertheindividualtests,noranaggregation
ofthesetests,preventthesystem'sintendeduse,orcompromiseitssafetyandeffectiveness.Additionally,yourfirmisstill
reviewingandupdatingtheinvestigationof5ofthe12identifiedrequirementsaspartoftheinitialcorrection.Yourfirm's
investigationfoundthatthedesignrequirementsandverificationprocessesdonotcontainsufficientinfrastructuretoensure
consistentexecutionoftherequirementsandverificationactivities.Yourfirm'sactionplaninvolvesrevisingrequirement
procedurestoincludeareviewprocesstodeterminetheadequacyoftestcases,alignmentofDesignChange,DefectManagement
andDesignValidationprocesseswithupdatestoDesignInputsandDesignVerification/Validationprocesses,developingand
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm258307.htm

2/10

1412015

WarningLetters>PhilipsMedicalSystems(Cleveland)Inc6/7/11

conductinginstructorledtrainingonrevisedprocesses,ProductTraining,GoodDocumentationPractices(GDP),andreviewing
DesignInputsandVerification/ValidationprocessITtools.Theplannedrevisions,however,havenotbeenfullycommunicatedor
approvedthroughyourfirmsapprovalprocessandtheimplementationoftherequiredchangesandtraininghasnotbeen
performed.

5.Failuretoestablishandmaintainadequateprocedurestovalidatethedesignofthedeviceinordertoensurethatthe
deviceconformstodefineduserneedsandintendeduses,asrequiredby21CFR820.30(g).

Forexample,areviewof23designinputsassociatedwiththeCondorCT/PETsystem,(CondorCustomerRequirements
SpecificationRev.F,dated08/24/09)showedthat7ofthedesigninputseitherdidnotmeetspecification,werenot
adequatelytested,ordidnotshowquantifiableresults.
RequirementGEMCR1338identifiesthatthreedifferenttypesofretrospectivePETscanacquisitionsbeimplemented.Only
twoacquisitions,arespiratorygatedCTscanforCTACandarespiratorygatedPETscaninaccordancewithValidationTest
Case2650(VALTC2650),weretestedandrecorded.
RequirementGEMCR1349.12includesthatwaveformstatisticsrelatedtotheperiod,amplitude,andfull
inhalation/exhalationlocationisavailabletotheuser.VerificationTestCase4807(VERTC4807)statesthatamongother
thingsinternalaverageandstandarddeviation,amplitudeaverageandstandarddeviationbeavailabletotheuser.On
4/8/09,thesystemfailedtherequirementsofVERTC4807fornotdisplayingthestandarddeviations,defect
NMDBa00025399wascreatedtoaddressthisissue.Todatethisissuehasnotbeenresolvedandhasbeenpostponedtoa
laterdesign.ThesubsequentValidationTestCase(VALTC2193)was"passed"on8/4/09eventhoughthereweredefects
foundandadefectreporthadbeeninitiatedasaresultofpreviouslyfailedverificationtesting.
RequirementGEMCR1922identifiesasystemsensitivityshallbegreaterorequalto6000cps/MBq.VALTC3099documents
thaton8/25/09thistestfailed.Adefectreport(NMDBa00029183)wasopened8/27/09whichstatedthatthedefectcan
remainopenbutcontinuestoneedtobeworkedon.Todatethereisnoevidencethatthisissueisbeingaddressed.
RequirementGEMCR22identifiesthatthemaximumverticalpositionvariationrelativetothesystemlaserreferencemarker
be(b)(4)forallpatientsinallowableweightrange.VALTC934failedon8/7/09,resultinginthefilingofdefectreport
NMDBa00029061.ThedefectreportstatesthatthetestwasaddressedaspartofaRandomRegression&StressTest
Worksheet(XNGN0370557)completed4/8/09.Therearenorecordsoftheresultsfromthistesting.
RequirementGEMCR1659identifiesthattheCTGantryphysicalpatientaperturebeatleast85cm.Thetest(VALTC3020)
waspassedwithnodocumentationoftheactualmeasuredvalueon7/31/09.
RequirementGEMCR320astestedbyVALTC600identifiestestingatorsophantomwhilesettingtherateto(b)(4)(tomimic
heartrate)foracardiacPETacquisition.Thesystemwastested(VALTC600)at(b)(4)andpassedwithnoexplanationwhy
thiswasacceptable.
RequirementGEMCR1505identifiesthatthesystembeabletodisplayimagesthatareviewableonaGemini3.3orlater
version.Thesystemwastested(VALTC2216)andpassedwithnodocumentationofwhichsystemwastested.
Wehavereviewedyourresponsesandhaveconcludedthattheyareinadequate.Yourfirmhasperformedareviewofthe
nonconformitiesandyourfirmdeterminedthatneithertheindividualtests,noranaggregationofthesetests,preventthe
system'sintendeduse,orcompromiseitssafetyandeffectiveness.Yourfirmhasnotaddressedthedeficiencyobservedwith
regardtoinadequatevalidationtestingordocumentationofvalidationresults.

6.Failuretoensurethattheriskanalysisisperformedwhereappropriateduringthedesignvalidation,asrequiredby21
CFR820.30(g).Forexample:

A.AreviewoftheriskanalysissurroundingtheCondorBigBoreNMdeviceshowedthatnotallhazardsassociatedwiththe
devicewereenteredintotheRiskManagementSummary(RMS)forthedevice.Thereweretwodefectsfoundduring
verificationtesting,defectNMDBa00027443whichidentifiedaninabilitytoheartheresponseofindividualsinthePETgantry
anddefectNMDBa00028653whichidentifiedbetasiteCondorcrosshairsthatdonotintersect.Thesedefectsintroducednew
hazardswhichwerenotaddedtotheRMS.Theidentifiedriskswere:thatapatientmaynotbeheardatthecontrolconsole
andthatthelasersusedforlandmarkidentificationdonotintersect.

Wehavereviewedyourresponsesandhaveconcludedthattheadequacyoftheresponsescannotbedeterminedatthistime.Your
firmperformedanauditoftheCondordefectson11/08/2010tocapturetheobservedhazards.Yourfirm'sinvestigationidentified
thattheRiskManagementprocessanditsrelationshiptotheCAPA,DefectManagement,ComplaintHandling,andAdverseEvent
ReportingandCorrectionsandRemovalsprocessesdidnotincludemeasurestoensurethatanynewhazardsorrisksidentified
throughouttheproduct'slifecyclewereaddedtotheRiskManagementFile.Yourfirm'sactionplanincludesrevisingandcreating
(asneeded)CT/NMRiskManagementprocedurestoensureregulatorycomplianceandlinkagestointerdependentprocesses
(CAPA,complainthandling,defectmanagement,correctionsandremovals,adverseeventreporting,nonconformingproduct,
equipmentcontrols,internalauditing,managementreviews),developingandconductinginstructorledtrainingonrevised
procedures,creatingofHazard/HarmMatrixtobeusedinComplaintHandlingandAdverseEventReporting,andreviewingRisk
ManagementprocessITtools.Theplannedrevisions,however,havenotbeenfullycommunicatedorapprovedthroughyourfirms
approvalprocessandtheimplementationoftherequiredchangesandtraininghasnotbeenperformed.

B.TheWorkManagementWorkInstructionprocedures(NMC310,RevC)describethatonlyhazardswithariskgreater
thanacombinedtotalof12(expressedasariskproductnumberorRPNscore)areevaluatedforadditionintotheRMF.This
scoreiscalculatedasseverity(14)xProbability(16)xdetectability(14)=RPN.Duringtheinvestigation,yourfirmre
evaluatedtheRPNscoresassociatedwiththisprojectinCondorDefectRiskAnalysisAudit(XNGR0383904RevA)andfound
thatonly64%oftheoriginalscoresremainedthesame.Twentythreepercentoftherevieweddefectswereevaluatedto
havedecreasedRPN,andtheremaining13%receivedanincreasedRPNthatrequiredevaluationforadditionintotheRMF.

Wehavereviewedyourresponsesandhaveconcludedthattheadequacyoftheresponsescannotbedeterminedatthistime.The
RiskManagementFileforCondorBigBoreNMDevice#XNGN0380018,Revision04,wasrevisedtoincludehazardsidentified
duringthedevelopmentcycle,regardlessoftheRPN.Therefore,allidentifiedhazardsarecapturedintheRMF.Yourfirm's
investigationidentifiedthattheRiskManagementprocessanditsrelationshiptotheCAPA,DefectManagement,Complaint
Handling,andAdverseEventReportingandCorrectionsandRemovalsprocessesdidnotincludemeasurestoensurethatanynew
hazardsorrisksidentifiedthroughouttheproduct'slifecyclewereaddedtotheRiskManagementFile.Yourfirm'sactionplan
includesrevisingandcreating(asneeded)CT/NMRiskManagementprocedurestoensureregulatorycomplianceandlinkagesto
interdependentprocesses(CAPA,complainthandling,defectmanagement,correctionsandremovals,adverseeventreporting,
nonconformingproduct,equipmentcontrols,internalauditing,managementreviews),developingandconductinginstructorled
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm258307.htm

3/10

1412015

WarningLetters>PhilipsMedicalSystems(Cleveland)Inc6/7/11

trainingonrevisedprocedures,creatingofHazard/HarmMatrixtobeusedinComplaintHandlingandAdverseEventReporting,
andreviewingRiskManagementprocessITtools.Theactionplan,however,hasnotbeenfullycommunicatedorapprovedthrough
yourfirmsapprovalprocessandtheimplementationoftherequiredchangesandtraininghasnotbeenperformed.

7.Failuretovalidateaprocesswithahighdegreeofassuranceinaccordancetoanestablishedandapprovedprocedure
wheretheprocesscannotbefullyverifiedbysubsequentinspectionandtest,asrequiredby21CFR820.75(a).For
example:

A.Yourfirmhasnotvalidatedthedegassingprocedure(NMEP3685RevA)forvariablessuchaspressureandtime.In
addition,yourfirmisnotmonitoringorrecordingtheseparameters.

Wehavereviewedyourresponsesandhaveconcludedthattheadequacyoftheresponsescannotbedeterminedatthistime.Your
firmcompletedthevalidationofthedegassing/gluingprocesson02/17/2011.Duringthevalidation,yourfirmcontractedathird
partytoprovideoversightforprocess.Yourfirm'sinvestigationintothesystemicdeficiencyidentifiedthattheprocessvalidation
processwasnotconsistentlyappliedtoproductionprocesses.Therefore,yourfirm'sactionplaninvolvesrevisingtheprocess
validationprocedure,revisingdesigntransferprocedurestoensurelinkageandalignmentwiththerevisedprocessvalidation
procedure,conductinginstructorledprocessvalidationtraining,completingtheManufacturingValidationPlanforCT/NMproduct
linestodetermineifadditionalprocessvalidationsarerequired,andconductinganyadditionalprocessvalidations.Theaction
plan,however,hasnotbeenfullycommunicatedorapprovedthroughyourfirmsapprovalprocessandtheimplementationofthe
requiredchangesandtraininghasnotbeenperformed.

B.Deviationswerefound(spikesinimagequality)inthegluingValidationTestPlanReport(DHF116846Version01)which
arerequiredtobeaddressed,evaluated,andacceptedorrejectedbyyourfirmsManufacturingProcessValidation
procedure(BLSOP025RevA).Thesedeviationswerenotaddressedinthereport(DHF116846)oranysubsequent
document.

Wehavereviewedyourresponsesandhaveconcludedthattheadequacyoftheresponsescannotbedeterminedatthistime.Your
firmhasrevisedtheprocessvalidationproceduretoaddresstheitemsidentifiedinthegapanalysisperformedforBLSOP
025.Trainingwascompletedonthenewprocedureon02/16/2011.Yourfirm'sinvestigationintothesystemicdeficiencyidentified
thattheprocessvalidationprocesswasnotconsistentlyappliedtoproductionprocesses.Therefore,yourfirm'sactionplan
involvesrevisingtheprocessvalidationprocedure,revisingdesigntransferprocedurestoensurelinkageandalignmentwith
revisedprocessvalidationprocedure,conductinginstructorledprocessvalidationtraining,completingManufacturingValidation
PlanforCT/NMproductlinestodetermineifadditionalprocessvalidationsarerequired,andconductinganyadditionalprocess
validations.Theactionplan,however,hasnotbeenfullycommunicatedorapprovedthroughyourfirmsapprovalprocessandthe
implementationoftherequiredchangesandtraininghasnotbeenperformed.

C.Acceptancecriteriaforthe"pulltest"(totestgluestrengthatspecificdryingtimes)valueswerenotdefinedpriorto
conductingthestudies.

Wehavereviewedyourresponsesandhaveconcludedthattheadequacyoftheresponsescannotbedeterminedatthistime.Your
firmhascompletedthevalidationofthedegassing/gluingprocesson02/17/2011.Duringthevalidation,yourfirmcontracteda
thirdpartytoprovideoversightforprocess.Yourfirm'sinvestigationintothesystemicdeficiencyidentifiedthattheProcess
Validationprocesswasnotconsistentlyappliedtoproductionprocesses.Therefore,yourfirm'sactionplaninvolvesrevisingthe
ProcessValidationprocedure,revisingDesignTransferprocedurestoensurelinkageandalignmentwithrevisedProcessValidation
procedure,conductinginstructorledprocessvalidationtraining,completingManufacturingValidationPlanforCT/NMproductlines
todetermineifadditionalprocessvalidationsarerequired,andconductinganyadditionalProcessValidations.Theactionplan,
however,hasnotbeenfullycommunicatedorapprovedthroughyourfirmsapprovalprocessandtheimplementationofthe
requiredchangesandtraininghasnotbeenperformed.

D.YourfirmperformsasolderingoperationtorepairPCBs(PrintedCircuitBoards)forNMdeviceswhichfailduringfinal
assemblyandtesting.Allboardsaremanufacturedbycontractmanufacturers.Yourfirmhasnotvalidatedthissoldering
process,shownthatthetypeofsolder(b)(4) usedtorepairboardsisequivalenttothatsolder(b)(4)usedduring
production,orthatthesolderuseddoesnotadverselyaffectthedevice.

Wehavereviewedyourresponsesandhaveconcludedthattheadequacyoftheresponsescannotbedeterminedatthistime.Your
firmcompletedaretrospectivesolderingprocessvalidationon02/17/2011,andnoissueswerefoundtonecessitateafield
action.StandardSolderingReworkProcedure(NMEP3509)wasupdatedasaresultofthevalidationactivityandpersonneltrained
on01/24/2011.Inaddition,yourfirmhasindicatedthatinhousesolderingwillnolongertakeplace.Yourfirm'sinvestigationinto
thesystemicdeficiencyidentifiedthattheprocessvalidationprocesswasnotconsistentlyappliedtoproduction
processes.Therefore,yourfirm'sactionplaninvolvesrevisingtheprocessvalidationprocedure,revisingdesigntransfer
procedurestoensurelinkageandalignmentwithrevisedprocessvalidationprocedure,conductinginstructorledprocessvalidation
training,completingManufacturingValidationPlanforCT/NMproductlinestodetermineifadditionalprocessvalidationsare
required,andconductinganyadditionalprocessvalidations.Yourfirmsactionplanincludeschangestoimprovethesoldering
validationprocedure,buthasindicatedinitsresponsethatinhousesolderingwillnolongertakeplace.Yourfirm,however,has
notprovidedevidenceofimplementationofalloftheircorrectiveactions.

8.Failuretoestablishandmaintainadequaterequirements,includingqualityrequirements,thatmustbemetbysuppliers,
contractors,andconsultantsthatdefinethetypeandextentofcontroltobeexercisedovertheproduct,services,suppliers,
contractors,andconsultants,basedontheevaluationresults,asrequiredby21CFR820.50(a)(2).Forexample:

A.YourfirmreportedthefailureofaCPMmoduletoyoursupplieron10/8/08.Accordingtoamemofromyoursupplier
dated9/21/09,"Thisfailurewassupposedtobehighlightedandinvestigatedfurtherbythesupplier".Thiswasnotdoneby
thesupplieratthattime.Additionally,similarfailureswerereportedtothesupplierregardinginstanceson10/08and8/09.
ThissimilarfailureresultedintwoMDRreportsbyyourfirm.Norootcausewasreportedtoyourfirmuntil2/5/10bythe
supplier.Duringthistime,yourfirmdidnotapplyanyadditionalinspectionalactivities,increasedoversight,orevaluateany
additionalsuppliersforthispart.Additionally,yourfirmdidnotinitiateasuppliercorrectiveaction(SCAR)perprocedures
BLSOP095RevBforanidentifiedsupplierdefect.

Wehavereviewedyourresponsesandhaveconcludedthattheadequacyoftheresponsescannotbedeterminedatthistime.As
partofthecorrectionyourfirmperformedaretrospectiveSCAR(102700)whichwascreatedinordertoproperlydocumentthe
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm258307.htm

4/10

1412015

WarningLetters>PhilipsMedicalSystems(Cleveland)Inc6/7/11

previousactivitiesrelativetothisobservationissueandensuretheywereeffective.TheSCARwassenttoyoursupplier,(b)
(4),on12/10/2010perSupplierCorrectiveActionandPreventativeActionProcessBLSOP095Rev.B.Inaddition,yourfirm
reviewedallcurrentManufacturingDefectReports(MDR)todeterminetheneedtoescalatereportsintoSCARs.Thereview
determinedthatretrospectiveSCARswerenotnecessary.Yourfirm'sinvestigationintothesystemicdeficiencyidentifiedthatthe
suppliercontrolsprocesses(includingSupplierCorrectiveActionandSupplierQualificationprocesses)didnotexerciseadequate
controlsoversupplierstoensureoverallproductquality.Yourfirm'sactionplanconsistsofrevisingthesuppliercontrols
processes,aligningCAPAsubsystemsandinterdependentprocessestoensureconsistentandcohesiveoverallassessmentand
processingofsupplierrelatednonconformities,generatinglistofcomponent/partspecificationswithriskrankings,assessingneed
forremediationofopenandclosedrecordsrelatingtothisobservation(e.g.,supplierfilesandSCARrecords),developand
implementremediationprotocolifrequiredperassessmentresults,developingandconductinginstructorledtrainingonrevised
processesandGoodDocumentationPractices(GDP),andreviewingsuppliercontrolsprocessITtools.Thesystemiccorrective
actionsidentifiedstillrequireapproval,verification,andimplementation.

B.AccordingtoSupplierQualityProgramSOP(BLSOP031,RevD),asupplierProfile/Selfassessmentquestionnaireistobe
filledoutforallConsultants,Contractors,ManufacturesandDistributors.Thisformisrequiredaspartofsupplier
evaluations.Areviewof17supplierfilesshowedthat:Tenoftheforms(59%)werenotcompletedunderthe"Methodof
Approval/Phaseoutsection"whichdescribesthelevelofcontrolforthesupplier.Sixoutofthetenfilescontaineda"Letter
toFile"writtenbytheSeniorManagerofSupplierQualityessentiallywaivingthisrequirement.Therearenoprovisions
withinanyofthesuppliermanagementprocedureswhichallowforanindividualtowaivesupplierqualifications.
Additionally,theremaining4fileshadnoselfassessmentquestionnaireor"LettertoFile".

Wehavereviewedyourresponsesandhaveconcludedthattheadequacyoftheresponsescannotbedeterminedatthistime.As
partofthecorrectionyourfirmhasreviewedthe17supplierfilescitedforcompletenessandverifiedthemtobecomplete,the
methodofapprovalhasbeenclearlydefinedforthe10suppliers,andthesupplierselfassessmentsthatweremissingwere
obtainedandaddedtothefile.Yourfirm'sinvestigationintothesystemicdeficiencyidentifiedthatthesuppliercontrolsprocesses
(includingSupplierCorrectiveActionandSupplierQualificationprocesses)didnotexerciseadequatecontrolsoversuppliersto
ensureoverallproductquality.Yourfirm'sactionplanconsistsofrevisingthesuppliercontrolsprocesses,aligningCAPA
subsystemsandinterdependentprocessestoensureconsistentandcohesiveoverallassessmentandprocessingofsupplierrelated
nonconformities,generatinglistofcomponent/partspecificationswithriskrankings,assessingneedforremediationofopenand
closedrecordsrelatingtothisobservation(e.g.,supplierfilesandSCARrecords),developandimplementremediationprotocolif
requiredperassessmentresults,developingandconductinginstructorledtrainingonrevisedprocessesandGoodDocumentation
Practices(GDP),andreviewingsuppliercontrolsprocessITtools.Thesystemiccorrectiveactionsidentifiedstillrequireapproval,
verification,andimplementation.

9.Failuretoadequatelyestablishandmaintainproceduresforreceiving,reviewing,andevaluatingcomplaintsbyaformally
designatedunit,asrequiredby21CFR820.198(a).

Forexample,accordingtoRegulatoryandApprobationComplaintHandlingProcedureXCTW0341105Rev.L,thecomplaint
coordinatoristoentercomplaintswithinonebusinessdayofreceiptandComplaintHandlingProcessBLSOP079Rev:C,which
statesthatcomplaintsaretobeenteredintothecomplaintsystemwithintwobusinessdays.Areviewof37complaintfiles
revealedthat17complaintswerenotfiledwithintheestablishedtimelimits.Amongthese17complaints,thefollowingfourwere
notenteredasormanagedasacomplaintforamonthorlongeraftertheincidentdate.
Complaint358953documentsthatyourfirmwasinformedofreportedartifactsinSlabVieweron12/9/09,butdidnotopen
acomplaintuntil4/22/10(morethanfourmonthslater).
Complaint404949documentsthatyourfirmwasmadeawareofareportedclearblockartifacton6/22/10,butdidnotopen
acomplaintuntil8/18/10(nearlytwomonthslater).
Complaint347680documentsthatyourfirmwasinformedofapixelartifacton12/8/09,butdidnotopenacomplaintuntil
3/24/10(morethanthreemonthslater).
Complaint364812documentsthatyourfirmwasinformedofanissuewithidentifyinglivervolumeon4/1/10,butdidnot
openacomplaintuntil5/10/10(overonemonthlater).
Wehavereviewedyourresponsesandhaveconcludedthattheadequacyoftheresponsescannotbedeterminedatthistime.As
partofthecorrectionyourfirmnowconductsweeklykeywordsearchesonservicerecordsinaccordancewiththeServiceOrder
Reviewprocedure(XI060010datedJanuary6,2010).Yourfirm'sinvestigationidentifiedthattheServiceCallCenterandService
Recordsprocessesdidnotincludemechanismstoensurethatallnonconformitiesmeetingthedefinitionofacomplaintwere
identifiedorroutedthroughtheComplaintHandlingProcess.Yourfirm'sactionplaninvolvesrevisingtheCT/NMComplaint
Handlingprocedures,revisingproceduresforinterdependentprocessesinaccordancewithcomplainthandlingrequirements,
developingandconductinginstructorledtrainingonrevisedprocesses,reviewingComplaintHandlingITprocesstools,and
investigatingPotentialITmonitoringsolutionswillbeinvestigatedtofacilitatetimelycomplaintcreation.Thesystemiccorrective
actionsidentifiedintheactionplanhavenotbeencompleted,approved,orimplementedyet.

10.Failuretoreview,evaluate,andinvestigateanycomplaintinvolvingthepossiblefailureofadevice,labeling,or
packagingtomeetanyofitsspecifications,asrequiredby21CFR820.198(c).Forexample:

A.From8/1/20099/1/2010therewere27DefectReportsforcomputertomography(CT)systems(foundinclinicaluse)
thathavebeenidentifiedbyyourfirmascomplaintswhichwerenotenteredintoyourfirm'scomplaintsystemandthus
werenotmanagedascomplaints.Examplesofthesedefectreportsinclude:
DefectCTUDT00189668initiatedon1/14/10describesthatbatchreferencelinesdonotcorrespondtotherealbatch.The
firmhasidentifiedthisissueasahazardinthedefectreport.
DefectCTUDT00177876initiatedon8/20/09describesthatalifesyncerrorcausestheEStoptoopenandthiscanhappen
atanytimeincludingduringascan.Thefirmhasidentifiedthisissueasahazardinthedefectreport.
DefectCTUDT00188358initiatedon12/30/09describesthatwhenloadingacardiachelixscantoCCA(Comprehensive
CardiacAnalysis)thatwassentfromthescanneronthePortalserverwiththeECGwave,whereamessagestating,
"cannotfindoneormoreslicesontheserver.Pleaserebuilddatabase.CCAwillnowclose".Thisdefectdidnothavea
hazardidentified.
Wehavereviewedyourresponsesandhaveconcludedthattheadequacyoftheresponsescannotbedeterminedatthistime.As
partofthecorrectionyourfirmperformedananalysisofallengineeringdefectstoconfirmthatdefectsthatmeetthedefinitionof
acomplainthavebeenenteredintothecomplaintsystem.Inaddition,theciteddefectshavebeenenteredintothecomplaint
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm258307.htm

5/10

1412015

WarningLetters>PhilipsMedicalSystems(Cleveland)Inc6/7/11

systemandindependentQ&Rweeklyauditsoftheengineeringdefectdatabasearebeingperformedtomakecertainthatdefects
areappropriatelyenteredintoTrackWise.Theinvestigationperformedbyyourfirmtoaddressthesystemicdeficiencyidentified
inadequatecomplainthandlingprocessesthatdidnotensurecompleteandconsistenthandlingofcomplaintsandcomplaintdata
sources.Yourfirmwillbemodifyingthecomplainthandlingprocesstoimproveidentificationofpotentialcomplaintdatasources,
clarifydefinitionofcomplaint,improvetherequirementsforinformationgatheringandcomplaintevaluation,initialrisk
assessment,definecriteriatodetermineneedforrootcause,andthedevelopmentofHazard/Harmmatrixtofacilitatecomplaint
handling.Thesystemiccorrectiveactionsidentifiedbyyourfirmareunderevaluationandrequireapproval,implementation,and
trainingwhichhasnotbeencompletedyet.

B.Duringthesametimeframefrom8/1/20099/1/2010therewereanadditional23DefectReportsfornuclearmedicine
(NM)systems(foundinclinicaluse)whichyourfirmhasidentifiedascomplaintsbuthavenotyetbeenenteredintoyour
firm'scomplaintsystem.Examplesofthesedefectreportsinclude:
DefectNMDBa00027915initiatedon4/13/09describesthattheactivityconcentrationscalingfactorcouldgiveadifferent
valuethanthatembeddedintheDICOMfileforPETsystems.Yourfirmhasidentifiedthisissueasahazardinthedefect
report.
DefectNMDBa00030868initiatedon3/1/10describesthatthecurrentdesignoftheflatpalletguiderailisnotasrobustas
requiredandthatonehasbrokeninthefield.Yourfirmhasidentifiedthisissueasahazardinthedefectreport.
DefectNMDBa00029627initiatedon10/12/09describesthattwosetscrewsusedonthetableweremissingfromtheupper
andlowerpalletscausingthelowerpallettojumpgearteeth.
Wehavereviewedyourresponsesandhaveconcludedthattheadequacyoftheresponsescannotbedeterminedatthistime.As
partofthecorrectionyourfirmperformedananalysisofallengineeringdefectstoconfirmthatdefectsthatmeetthedefinitionof
acomplainthavebeenenteredintothecomplaintsystem.Inaddition,theciteddefectshavebeenenteredintothecomplaint
systemandindependentQ&Rweeklyauditsoftheengineeringdefectdatabasearebeingperformedtomakecertainthatdefects
areappropriatelyenteredintoTrackWise.Theinvestigationperformedbyyourfirmtoaddressthesystemicdeficiencyidentified
inadequatecomplainthandlingprocessesthatdidnotensurecompleteandconsistenthandlingofcomplaintsandcomplaintdata
sources.Yourfirmwillbemodifyingthecomplainthandlingprocesstoimproveidentificationofpotentialcomplaintdatasources,
clarifydefinitionofcomplaint,improvetherequirementsforinformationgatheringandcomplaintevaluation,initialrisk
assessment,definecriteriatodetermineneedforrootcause,andthedevelopmentofHazard/Harmmatrixtofacilitatecomplaint
handling.Thesystemiccorrectiveactionsidentifiedbyyourfirmareunderevaluationandrequireapproval,implementation,and
trainingwhichhasnotbeencompletedyet.

C.Additionally,theinvestigationrevealedthefollowingcomplaintsthatwereenteredintothecomplaintsystem,buthaveno
documentedevaluationsforinvestigationsorrationalefornotinvestigating.
Complaint385750initiatedon7/9/10regardingimagequalityissueswithDynamicDoseModulation(DDOM)onaBrilliance
64CTsystem.
Complaint342464initiated2/22/10regardinganMXTwinthatwasreportedtoemitaburningsmellandsmoke.
Complaint353508initiated4/8/10regardingaBrilliance40CTsystemwherepartoftheCTunitbegantosmoke.
Complaint389776initiated7/20/10regardingBrilliance64wherethetransistorunitcaughtonfire.
Complaint385818initiated6/2/09reportsthatanMX8000CTscannercaughtonfire.
Wehavereviewedyourresponsesandhaveconcludedthattheadequacyoftheresponsescannotbedeterminedatthistime.As
partofthecorrectionyourfirmhasupdatedcomplaints#385750,342464,353508,389776,and385818inthesystemfor
completeness.Theupdateswerecompletedon2/15/2011.Theinvestigationperformedbyyourfirmtoaddressthesystemic
deficiencyidentifiedinadequatecomplainthandlingprocessesthatdidnotensurecompleteandconsistenthandlingofcomplaints
andcomplaintdatasources.Yourfirmwillbemodifyingthecomplainthandlingprocesstoimproveidentificationofpotential
complaintdatasources,clarifydefinitionofcomplaint,improvetherequirementsforinformationgatheringandcomplaint
evaluation,initialriskassessment,definecriteriatodetermineneedforrootcause,andthedevelopmentofHazard/Harmmatrix
tofacilitatecomplainthandling.Thesystemiccorrectiveactionsidentifiedbyyourfirmareunderevaluationandrequireapproval,
implementation,andtrainingwhichhasnotbeencompletedyet.

11.Failuretopromptlyreview,evaluate,andinvestigateanycomplaintthatrepresentsaneventwhichmustbereportedto
FDAunderpart21CFR803,asrequiredby21CFR820.198(d).Forexample:

A.Complaint298784,wasinitiatedon11/2/09inresponsetoauserwhowasseverelyshockedbythecircuitbreakerinan
MX8000whiletheCTsystemwasreenergizing.Thebreakerwasreportedtotripaftertablepositioningwasused(raisingor
lowingthetable).Thecircuitbreakerandaverticalmotorwerereplacedinthefieldfortheunit.AnMDRwasfiledon
11/18/09.Yourfirmdidnotinvestigatethiscomplainttodeterminetherootcause.

Wehavereviewedyourresponsesandhaveconcludedthattheadequacyoftheresponsescannotbedeterminedatthistime.The
investigationperformedbyyourfirmtoaddressthesystemicdeficiencyidentifiedinadequatecomplainthandlingprocessesthat
didnotensurecompleteandconsistenthandlingofcomplaintsandcomplaintdatasources.Yourfirmwillbemodifyingthe
complainthandlingprocesstoimproveidentificationofpotentialcomplaintdatasources,clarifydefinitionofcomplaint,improve
therequirementsforinformationgatheringandcomplaintevaluation,initialriskassessment,definecriteriatodetermineneedfor
rootcause,andthedevelopmentofHazard/Harmmatrixtofacilitatecomplainthandling.Thesystemiccorrectiveactions
identifiedbyyourfirmareunderevaluationandrequireapproval,implementation,andtrainingwhichhasnotbeencompletedyet.

B.Complaint376831,wasinitiatedon3/1/10inresponsetoacustomercomplaint(reportedbyaPhysician)oftotally
unacceptableimagessincethe3.5.1upgradeforthePulmogatingstudiesregardingGeminiPETCTsystems.Itwasreported
byyourfirmthatthisdefectcouldgivefalsenegativesinpatients.Yourfirmdidnotcreateacomplaintrecorduntil6/15/10
(over3monthstocreatethefile).YourfirmsubsequentlyreportedanMDR(late)on9/2/10(MDR201000026).

Wehavereviewedyourresponsesandhaveconcludedthattheadequacyoftheresponsescannotbedeterminedatthistime.The
investigationperformedbyyourfirmtoaddressthesystemicdeficiencyidentifiedinadequatecomplainthandlingprocessesthat
didnotensurecompleteandconsistenthandlingofcomplaintsandcomplaintdatasources.Yourfirmwillbemodifyingthe
complainthandlingprocesstoimproveidentificationofpotentialcomplaintdatasources,clarifydefinitionofcomplaint,improve
therequirementsforinformationgatheringandcomplaintevaluation,initialriskassessment,definecriteriatodetermineneedfor
rootcause,andthedevelopmentofHazard/Harmmatrixtofacilitatecomplainthandling.Thesystemiccorrectiveactions
identifiedbyyourfirmareunderevaluationandrequireapproval,implementation,andtrainingwhichhasnotbeencompletedyet.
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm258307.htm

6/10

1412015

WarningLetters>PhilipsMedicalSystems(Cleveland)Inc6/7/11

12.Failuretoestablishandmaintainadequateprocedurestocontrolproductthatdoesnotconformtospecified
requirements,asrequiredby21CFR820.90(a).

Forexample,2outof21testingbaynotebookswerereviewedduringthisinspection.Thesenotebooksareusedtorecord
informationduringthefinalassemblyandtestingofboththecomputertomography(CT)andnuclearmedicine(NM)productlines,
intheirrespectivebays.PeryourfirmsNonConformingMaterialControlProcessesSOP(XCTW0504004,RevB1)andInitialData
EntryProcessforManufacturingDefectReportingDatabaseSOP(NMC405,Rev.M),anydefectsfoundduringtestingmustbe
documentedunderaDefectReport.Thereviewofthetwobaynotebooksrevealedatotalof24entries(10fromthebay5
notebookand14frombay14notebook)whichconstitutedefects(nonconformingmaterial)andhavenoassociatedmanufacturing
defectreport(DefectReport)asrequiredbythefirmsprocedures.Assuch,thesedefectsarenotbeingtrended,includedfor
potentialcorrectiveactionsorincludedaspartofthedevicehistoryrecord(s).

Wehavereviewedyourresponsesdated12/23/2010,2/28/2011,and3/31/2011andhaveconcludedthattheadequacyofthe
responsescannotbedeterminedatthistime.Aspartofthecorrectionsandcorrectiveactionsyourfirmhasperformedthe
followingactivities:
Aproductholdandstopshipment,wasissuedagainstNMandCTproducts(respectively)inprocessatthetimethatthebay
bookswereinuse.
AreviewoftheDHRsfortheidentifiedsuspectNMunitshasbeencompletedon12/23/2010anditwasdeterminedthatall
testingwasfoundtobecompleteandaccurate.
AreviewoftheCTDHRsforthesuspectCTunitswascompleted.Noissueswereidentifiedforunitsinproductionbutthe
analysisdididentifytheneedforcorrectionson2unitsinthefield.
PreInstallationProcedure#1651wasrevisedtoeliminatebaybooks.Trainingwasconductedon12/01/2010.
Anauditofalllogbooks(baybooks)inhousetoensurethatanysuspectedproductqualityissueswereresolved
adequately.Noissueswereidentifiedforunitsinproductionbuttheanalysisdididentifytheneedforcorrectionson2units
inthefield.
RevisionsweremadetoyourNonconformingProductproceduresandtrainingwascompletedon12/15/2010and2/17/2011.
YourfirmfoundduringtheinvestigationthatnonconformitiesidentifiedduringInspectionandTestwerenotalwaysincludedinthe
DeviceHistoryRecord.YourfirmsactionplanconsistsofrevisingCT/NMControlofNonconformingProductprocedures,aligning
interdependentprocesses,includingInspectionandTest/AcceptanceandDHRprocedures,totherevisionsoftheControlof
NonconformingProductprocedure,assessingneedforremediationofopenandclosedrecords,developingandconducting
instructorledtrainingonrevisedprocesses,GoodDocumentationPractices(GDP)anddefectawareness,investigatingalternative
methodforshiftchangecommunicationandupdatingproceduresaccordingly,andreviewingnonconformingproductprocessIT
tools.Notallofthesystemiccorrectiveactionsidentifiedintheactionplanhavebeencompletedorimplementedyet.

13.Failuretoestablishandmaintainadequateprocedurestocontrolalldocuments,asrequiredby21CFR820.40.

Forexample,thereare21manufacturingtestbaysatyourfirmfortestingandfinalassemblyofallCTandNMsystems.Eachof
thesebayshasanassociatedtestingbaynotebookwhichismaintainedbythetechnicians.Thesebookscontaininformation
relatingtodefectsandfailuresassociatedwiththedevicesduringtesting.AccordingtoyourfirmsQualityManualQM00RevP,
Recordsmustremainlegible,readilyidentifiable,andretrievable,andmustbestoredtominimizedeteriorationandprevent
loss.Thesebooks,however,arenotcontrolledbyyourfirm,donotfollowyourfirm'sdocumentcontrolprocedures,andare
destroyedaftertheyarefilled.Inaddition,areviewofthenotebooksshowedthat:
Whiteoutisusedtocoveroverdata
Originaldataisobliterated
Therearenoinitialsordatesforlineoutitems
Accordingtoyourfirm,employeesaretrainedtonotcoveroverdataandtoinitialanddateanychangesorlinethrough.

Wehavereviewedyourresponsesandhaveconcludedthattheadequacyoftheresponsescannotbedeterminedatthistime.As
partofthecorrectionyourfirmremovedallbaybooksforanalysisandreplacedthemwithanalternativemethodof
communicationbetweentechniciansandshiftchanges.Inaddition,productionpersonnelwereretrainedonGoodDocumentation
Practiceson12/18/2010and2/4/2011.Yourfirm'sinvestigationdeterminedthattheinspectionandtestprocessdidnoteffectively
reinforcegooddocumentationpracticesoridentifyallpotentialsourcesofnonconformities.Theactionplanconsistsofdeveloping
GoodDocumentationPracticesprocedure,revisingControlofQualityRecordsproceduresinaccordancewiththeGood
DocumentationPractices,developingandconductinginstructorledtrainingonrevisedGoodDocumentationPracticesandControl
ofQualityRecordsprocedures,andReviewrelatedprocessITtools.Thesystemiccorrectiveactionsidentifiedintheactionplan
havenotbeencompleted,approved,orimplementedyet.

14.Failuretoensurethatalldocumentsarereviewedandapprovedbyadesignatedindividualpriortoissuanceandthat
documentsareavailableatalllocationsforwhichtheyaredesignated,used,orotherwisenecessary,andallobsolete
documentsarepromptlyremovedfromallpointsofuseorotherwisepreventedfromunintendeduse,asrequiredby21CFR
820.40(a).

Forexample,documentsthatwerenotapprovedwereobservedatalocationwheretheyarebeingused.Specifically,thePhilips
HealthcareSupplierProfileDatabasewaschangedinJune2010toaltertheparametersusedformanagingthesuppliersinthe
database.AsofOctober5,2010,theworkinstructionforthisdatabase(UXW141710Rev2)wasstillbeingusedatyourfirms
Cleveland,OHfacilitywithnodocumentedofficialreleaseorapproval.

Wehavereviewedyourresponsesandhaveconcludedthattheadequacyoftheresponsescannotbedeterminedatthistime.As
partofthecorrectiontotheobservationyourfirmrevisedtheSupplierProfileDatabase(SPD)Managementprocedure(UXW
141710,Rev2)on10/28/2010andpersonnelweretrainedon12/17/2010.Yourfirm'sinvestigationintothesystemicdeficiency
foundthatthedocumentcontrolprocessdidnotprovideatransitioningmechanismtoensureeffectiveimplementationofprocess
changes.Yourfirm'sactionplanincludesrevisionstotheprocesswhichincludeoversightbyachangecontrolboard.Thechange
controlboardisintheprocessofbeingdevelopedandestablished.Thesystemiccorrectiveactionsidentifiedintheactionplan
havenotbeencompleted,approved,orimplementedyet.

15.Failuretoestablishandmaintainadequateprocedurestoensurethatmixups,damage,deterioration,contamination,or
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm258307.htm

7/10

1412015

WarningLetters>PhilipsMedicalSystems(Cleveland)Inc6/7/11

otheradverseeffectstoproductdonotoccurduringhandling,asrequiredby21CFR820.140.

Forexample,duringassemblyofalldevicesyourfirmutilizesstoragebinsinordertoretrievethecorrectpartnumberto
manufacturetheNMandCTdevices.Asamplingof16ofthesebinsshowedthat9(56%)ofthemhadmultipleincorrectpartsin
thebins.Thebinssampledweremostlyassortedtypesofscrews,bolts,nutsandwashers.Thedifferencesinthesepartswasnot
alwayseasilyapparentasamongotherthings,splitwasherswerefoundwithregularwashers,differentsizeddiameterwashers
wereintermixedanddifferentscrewsizeswereintermingled.Noneofyourfirm'sstandardoperatingproceduresaddressthe
controlofthesebins.Inaddition,Mr.Vinhais,DirectorofQualityandRegulatory,indicatedthatnoproceduresdescribingcontrol
ofthesebinsexisted.

Wehavereviewedyourresponsesandhaveconcludedthattheadequacyoftheresponsescannotbedeterminedatthistime.Your
firmhasperformedananalysisofcomplaints,installationdefects,andrectorydefectreportsanddeterminedthatnomixed
materialhasbeenusedinappropriatelyinaproduct.Additionally,thematerialstoragebinshavebeenmodifiedtoincludeacover
andsimilarlysizedandshapedcomponentsarenolongerstorednexttoeachother.Employeeawarenesstrainingtothenew
changeswascompletedon2/16/2011.Yourfirm'sinvestigationintothesystemicdeficiencyfoundthatprocessesforhandling
materialinproductiondonotadequatelyaddressmaterialsstaging,procurement,handling,componentstockreturns,orspecials
ortheidentificationofproductionmaterial,includingsegregation,labelingandstorage.Yourfirm'sactionplanincludes
investigatingalternativematerialsstorageandhandlingrequirements.Thesystemiccorrectiveactionsidentifiedintheactionplan
havenotbeencompleted,approved,orimplementedyet.

16.Failuretoensurethatallpersonnelaretrainedtoadequatelyperformtheirassignedresponsibilities,asrequiredby21
CFR820.25(b).Forexample:

A.EmployeesperformingincominginspectionalactivitieswerenottrainedonthestatisticalsamplingplanforReceiving
Inspections(BLSOP092Rev:A).Areviewof7inspectionalactivitieswhichrequiredasamplingforinspectionrevealedthat
twooftheinspectionswerenotsampledproperly.Accordingtoyourfirm,thereare4peoplewhocananddoperformthis
function,however,noneoftheseemployeesweretrainedontheprocedures.

Wehavereviewedyourresponsesandhaveconcludedthattheadequacyoftheresponsescannotbedeterminedatthistime.Your
firmtrainedtherequiredpersonnelonprocedureBLSOP092on12/19/2010.Inaddition,yourfirmhasperformedaninvestigation
intothecitednonconformityandfoundthattrainingwasincompleteforanadditionalnineteen(19)documentsandisinthe
processofcompletingtheadditionaltraining.Yourfirmsactionplanincludes,revisingtheCT/NMtrainingprocedure,reviewing
andrevisinginterdependentproceduresinaccordancewithnewCT/NMTrainingprocedure,developingandconductinginstructor
ledtrainingonrevisedprocedures,anddevelopingandimplementinga"trainthetrainer"program.Theactionplanprovidedisin
processandhasnotbeencompletedorimplemented.

B.On10/13/10anemployeewasobservedworkingontheBrilliance16BigBoreCTlinenotwearinganelectrostatic
discharge(ESD)bracelet,whichpreventsdamagetoelectricalcomponentsfromstaticelectricity,whileworkingonthe
system.Thebraceletisrequiredforthestepnumber170ofOperation70.Thisrequirementisaddressedintrainingand
documentedinthelegendfortheOperationprocedure(OPERATION70ACCOLADE,document#2011Rev:J)andidentified
inyellowatanysteprequiringitintheprocedure.

Wehavereviewedyourresponsesandhaveconcludedthattheadequacyoftheresponsescannotbedeterminedatthistime.Your
firmhasimplementedacorrectiontotheobservationandhasprovidedpersonnelwithrefresherESDtraining.Yourfirms
investigationintothecitednonconformityfoundthatESDcontrolsdidnotsufficientlyensuretheproperhandlingandidentification
ofESDsensitivematerial.WithregardstoESDprotocol,yourfirmintendstoconductanauditofallcurrentESDcontrolsinplace,
includingequipment,toensuretheymeettherequirementsofthenewprocedures,revisemanufacturingESDcontrolprocedures,
revisePreventativeMaintenance(PM)andInspection,TestandCalibrationprocedurestoensurethattestequipmentrequiredfor
ESDtoolsareincludedinPMIcalibrationschedules.Theactionplanprovidedisinprocessandhasnotbeencompletedor
implemented.

Ourinspectionalsorevealedthatyourdevicesaremisbrandedundersection502(t)(2)oftheAct,21U.S.C.352(t)(2),inthatyour
firmfailedorrefusedtofurnishmaterialorinformationrespectingthedevicethatisrequiredbyorundersection519oftheAct,
21U.S.C.360i,and21CFRPart803MedicalDeviceReporting(MDR)regulation.Significantdeviationsinclude,butarenot
limitedto,thefollowing:

FailuretoreporttotheFDAnolaterthan30calendardaysafterthedayyoubecameawareofinformationthatreasonably
suggeststhatyourdevicemalfunctionedandwouldbelikelytocauseorcontributetoadeathorseriousinjuryifthemalfunction
weretorecur,asrequiredby21CFR803.50(a)(2).

Forexample,thefollowingcomplaintsdescribeMDRreportableeventsthatwerenotsubmittedtoFDAwithin30daysafterthe
dayyoubecameawareoftheevent:
Complaint371160
Complaint389776
Complaint385818
Complaint275356
Complaint351042
Complaint325458and
Complaint358511.
Wehavereviewedyourresponsesandhaveconcludedthattheadequacyoftheresponsescannotbedeterminedatthistime.Your
firmhascompletedareviewtoconfirmthatallcomplaintsnotedintheobservationhavebeenreportedandthatanyadditional
complaintshavealsobeenappropriatelyreported.YourfirmidentifiedthatthemechanismsforAdverseEventReportingdidnot
assureaccurateevaluationofadverseevents.ProcessrevisionsareunderwaytoaddressReportingCriteriadetermination,timely
evaluation,definitionsrelatedtoreporting,complainthandling,improvelinkagestointerdependentprocesses,andthe
development/useofHazard/Harmmatrixinconjunctionwithriskmanagementfilestofacilitateaccurateadverseevent
reporting.Modificationsandtrainingneedtobefullyidentifiedandimplemented.

Ourinspectionalsorevealedthatyourdevicesaremisbrandedundersection502(t)(2)oftheAct,21U.S.C.352(t)(2),inthatyour
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm258307.htm

8/10

1412015

WarningLetters>PhilipsMedicalSystems(Cleveland)Inc6/7/11

firmfailedorrefusedtofurnishmaterialorinformationrespectingthedevicethatisrequiredbyorundersection519oftheAct,
21U.S.C.360i,and21CFRPart806ReportsofCorrectionsandRemovalsregulation.Significantdeviationsinclude,butarenot
limitedto,thefollowing:

Failuretosubmitareportofacorrectionorremovalwithin10workingdaysofinitiatingsuchcorrectionorremoval,asrequired
by21CFR806.10(b).

Forexample,on9/3/09,yourfirmreceivedcomplaint284929regardingimpropercalculationsofcardiacwallthicknessduring
imagingstudiesintheExtendedBrillianceWorkstationforComputedTomography(CT)systems.Therootcausewasdeterminedto
beanimpropercalculationinthesoftware.YourfirmsentacustomernotificationlettertoallaffectedsitesinOctober2009.This
actionwasnotreportedtotheFDA.

Wehavereviewedyourresponsesandhaveconcludedtheyappeartobeadequate.YourfirmhassubmittedRecall152965
09129/10005CtotheFDAandsubmittedthedocumentationrequiredby21CFR806.20totheDistrictRecallCoordinator.Your
firmidentifiedthesystemicrootcausetobethattheproceduresforCorrectionsandRemovalsandFieldChangeOrders(FCO)
wereinadequatetoensurethatrecallactivitiesandregulatoryreportingrequirementswereaddressedinatimelyandcomplete
manner.RevisionsweremadetotheCorrectionsandRemovalsAndFieldChangeOrderprocessestoimprovereportingand
documentationrequirements,classificationofrecalls,andlinkagestointerdependentprocessesthatcouldidentifynon
conformitiesthatcouldresultinarecall.Thechangeswerecommunicatedtoappropriatepersonnelon02/08/2011.

Youshouldtakepromptactiontocorrecttheviolation(s)addressedinthisletter.Failuretopromptlycorrecttheseviolation(s)
mayresultinregulatoryactionbeinginitiatedbytheFoodandDrugAdministrationwithoutfurthernotice.Theseactionsinclude,
butarenotlimitedto,seizure,injunction,and/orcivilmoneypenalties.Also,federalagenciesareadvisedoftheissuanceofall
WarningLettersaboutdevicessothattheymaytakethisinformationintoaccountwhenconsideringtheawardof
contracts.Additionally,premarketapprovalapplicationsforClassIIIdevicestowhichtheQualitySystemregulationdeviations
arereasonablyrelatedwillnotbeapproveduntiltheviolationshavebeencorrected.RequestsforCertificatestoForeign
Governmentswillnotbegranteduntiltheviolationsrelatedtothesubjectdeviceshavebeencorrected.

Wearerequestingthatyousubmittothisofficeontheschedulebelow,certificationbyanoutsideexpertconsultantthathe/she
hasconductedanauditofyourestablishment'smanufacturingandqualityassurancesystemsrelativetotherequirementsofthe
deviceQSregulation(21CFR,Part820).Youshouldalsosubmitacopyoftheconsultant'sreport,andcertificationbyyour
establishment'sChiefExecutiveOfficer(ifotherthanyourself)thatheorshehasreviewedtheconsultant'sreportandthatyour
establishmenthasinitiatedorcompletedallcorrectionscalledforinthereport.Theinitialcertificationsofauditandcorrections
andsubsequentcertificationsofupdatedauditsandcorrections(ifrequired)shouldbesubmittedtothisofficebythefollowing
dates:
InitialcertificationsbyconsultantandestablishmentDecember7,2011.
Pleasenotifythisofficeinwritingwithinfifteen(15)workingdaysfromthedateyoureceivethisletterofthespecificstepsyou
havetakentocorrectthenotedviolations,includinganexplanationofhowyouplantopreventtheseviolation(s),orsimilar
violation(s),fromoccurringagain.Includedocumentationofthecorrectiveactionyouhavetaken.Ifyourplannedcorrectionswill
occurovertime,pleaseincludeatimetableforimplementationofthosecorrections.Ifcorrectiveactioncannotbecompleted
within15workingdays,statethereasonforthedelayandthetimewithinwhichthecorrectionswillbecompleted.

Yourresponseshouldbesentto:MarkE.Parmon,ComplianceOfficer,CincinnatiDistrict,6751StegerDrive,Cincinnati,
OH452373097.IfyouhaveanyquestionsaboutthecontentofthisletterpleasecontactMarkParmonat(513)6792700,Ext.
2162,or(513)6792773(fax).

Finally,youshouldknowthatthisletterisnotintendedtobeanallinclusivelistoftheviolation(s)atyourfacility.Itisyour
responsibilitytoensurecompliancewithapplicablelawsandregulationsadministeredbyFDA.Thespecificviolation(s)notedin
thisletterandintheInspectionalObservations,FormFDA483(FDA483),issuedatthecloseoutoftheinspectionmaybe
symptomaticofseriousproblemsinyourfirmsmanufacturingandqualityassurancesystems.Youshouldinvestigateand
determinethecausesoftheviolation(s),andtakepromptactionstocorrecttheviolation(s)andtobringyourproductsinto
compliance.

Sincerelyyours,
/S/
TeresaC.Thompson
DistrictDirector
CincinnatiDistrict

CloseOutLetter
PhilipsMedicalSystems(Cleveland),Inc.CloseOutLetter9/18/121
PageLastUpdated:10/05/2012
Note:Ifyouneedhelpaccessinginformationindifferentfileformats,seeInstructionsforDownloadingViewersandPlayers.
AccessibilityContactFDACareersFDABasicsFOIANoFearActSiteMapTransparencyWebsitePolicies
U.S.FoodandDrugAdministration
10903NewHampshireAvenue
SilverSpring,MD20993
Ph.1888INFOFDA(18884636332)
EmailFDA

ForGovernmentForPress
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm258307.htm

9/10

1412015

WarningLetters>PhilipsMedicalSystems(Cleveland)Inc6/7/11

CombinationProductsAdvisoryCommitteesScience&ResearchRegulatoryInformationSafetyEmergencyPreparedness
InternationalProgramsNews&EventsTrainingandContinuingEducationInspections/ComplianceState&LocalOfficials
ConsumersIndustryHealthProfessionalsFDAArchive

Linksonthispage:
1. /ICECI/EnforcementActions/WarningLetters/2011/ucm322274.htm

http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm258307.htm

10/10