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Home Inspections, Compliance, Enforcement, and Criminal Investigations Compliance Actions and Activities
Warning Letters 2013
Inspections,Compliance,Enforcement,andCriminalInvestigations

PugetSoundBloodCenterandProgram4/16/13

PublicHealthService
DepartmentofHealthandHumanServices FoodandDrugAdministration
SeattleDistrict
PacificRegion
2221526thAvenueSE,Suite210
Bothell,WA98021

Telephone:4253020340
FAX:4253020402

April16,2013

OVERNIGHTDELIVERY
SIGNATUREREQUIRED

InreplyrefertoWarningLetterSEA1316

JamesP.AuBuchon,MD,FCAP,FRCP(Edin)
PresidentandCEO
PugetSoundBloodCenterandProgram
921TerryAvenue
Seattle,Washington981041256

WARNINGLETTER

DearDr.AuBuchon:

TheFoodandDrugAdministrationconductedaninspectionofyourfirm,PugetSoundBloodCenter
(PSBC),locatedat921TerryAvenue,Seattle,Washington,fromJanuary14,2013February15,
2013.Duringtheinspection,FDAinvestigatorsdocumentedsignificantdeviationsfromapplicable
currentGoodManufacturingPractice(cGMP)regulationsforbloodandbloodproducts,Title21,Codeof
FederalRegulations(21CFR),Parts606,610and640andthecGMPregulationsforfinished
pharmaceuticals,21CFRPart211.Thesedeviationscauseyourbloodproductstobeadulteratedwithin
themeaningofSection501(a)(2)(B)oftheFood,DrugandCosmeticAct(theAct).[21U.S.C.351(a)
(2)(B)].Thesedeviationsincludebutarenotlimitedtothefollowing:

1.Whereaninvestigationunder21CFR211.192isconducted,failuretoincludeinthewrittenrecord
thefindingsoftheinvestigationandfollowup[21CFR211.198(b)(2)].

Yourfirmscomplaintrecordsaredeficientinthattheydonotincludethefindingsofaninvestigation
andthefollowup.Forexample,

(a)ARedBloodCellunitwasreturnedfromahospitalonJanuary14,2013,withacomplaint
thatitcontainedsmallgreenishclots.Therewasnodocumentedinvestigationbeyondavisual
inspectionoftheunitonitsreturn.TheunitwasredistributedonJanuary17,2013.

(b)OnAugust27,2012,aRedBloodCellunitwasrecordedinBloodTrackashavingaBlood
UnitVisualInspectionalert.Whenaunitfailsavisualinspection,BloodTrackgeneratesanerror
message.AccordingtoyourReferenceDocument:BloodTrackAlertTable,theerrormessage

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istobeprintedandtheresolutiondocumentedontheprintout.Theresolutiondescriptionforthis
unitstatesthatF/udocumentedonprintscreenConfirmOccurrenceReportForm(ORF)
done.Theprintscreencontainingthefollowupcouldnotbelocatedandtherewasnoother
documentedinvestigationofwhytheunitwasmarkedasfailingvisualinspectionorwhyitwas
returnedtoanavailablestatus.Theunitwasneverreturnedtoyourfirmandispresumed
transfused.

2.Failuretotakeimmediatecorrectiveactionandmaintainarecordofsuchactioniftheresultsof
thequalitycontroltestingindicatethattheproductdoesnotmeettheprescribedrequirements[21CFR
640.25(b)(4)].

(a)LeukoreducedPlateletproductshavenotmetthestandardsestablishedinyourproduct
qualitycontrolprocedures.Forexample,

i.ThestandardslistedintheComponentQualityControl(QC)TestingFrequency
ChartforPlateletsLeukocytesReduced(referredtoasPltLR),requireaminimum
yieldof5.5x1010plateletsinatleast75%ofproductstestedeachmonth.Yourfirmhas
testedatleastfourunitseachmonthandoutof30monthsreviewed,themonthlyQCtarget
of5.5x1010plateletsinatleast75%ofproductswasonlymetinAugust2011.

ii.AccordingtotheFrequencyChart,thestandardsforfilteredplateletsalsorequireat
least85%plateletrecoveryafterfiltrationin100%oftheproductstestedeachmonth.
[Yourspreadsheetidentifiesasecondstandardof(b)(4)%recoveryin(b)(4)%oftested
products].Themostrecentsingleunitthatmetthe85%recoverytargetwastestedonJuly
16,2010.ThemostrecentmonthwhensufficientunitsmetthepostfiltrationmonthlyQC
targetwasMay2010.SinceAugust2010,the%plateletrecovery,postfiltrationQCtesting
results,rangedfrom(b)(4)%(b)(4)%.

(b)Occurrenceswereopenedin2009and2010toaddresspriorqualitycontrolfailuresand
wereclosedinJanuary2010andMay2010despitetheproductcontinuingtofailtomeetthe
establishedstandards.Yourfirmdistributed(b)(4)unitsofPlateletsLeukocyteReducedbetween
August2010andJanuary2013.InAugust2010,yourfirmbeganusingadifferentfilterfor
plateletleukoreduction.Noinvestigationintothecurrentfailureshasbeenconducted.

3.Failuretoobtainapprovalforanexceptionoranalternativeprocedureinaccordancewith21CRF
640.120priortodistributingproductsmadeusingtheexceptionoralternativeprocedure[21CRF
640.120(a)].Specifically,

Suppliesandreagentswerenotusedinamannerconsistentwithinstructionsprovidedbythe
manufacturer.Forexample,yourtransfusionserviceusesafiltrationsystemforPlateletsthatis
labeledforuseinleukoreductionofpooledPlateletsandsingledonor(apheresis)Platelets.Thereisno
indicationbythemanufacturerofthefilterthatthesystemcanbeusedfortheleukoreductionof
Platelets.RecordsindicatethatyouhavebeenusingthefiltersinthismannersinceAugust2010,but
youhadnotrequestedanalternativeproceduretodistributetheproductpriortotheclosingdateofthe
mostcurrentinspection.

4.Failuretoestablishandmaintainwrittenstandardoperatingprocedureswhichincludeallstepsto
befollowedinthecollection,processing,compatibilitytesting,storage,anddistributionofbloodand
bloodcomponentsfortransfusion,includingproceduresforinvestigatingadversedonorandrecipient
reactions.[21CFR606.100(b)(9)and21CFR606.100(b)].

StandardOperatingProcedures(SOPs)werenotconsistentlyfollowedbyyourfirmscollectionand
transfusionservicesstaff.Forexample,

(a)BCS2340SOPrequirestheBloodCollectionService(BCS)nursingstafftocontact
donorswhoexperiencedlossofconsciousnessduringorafterthecollectionprocedureandto
documentthefollowupontheDonorReaction/ComplicationForm.OnOctober13,2012,and
October30,2012,donorsexperiencedlossofconsciousnesswhileinthecanteenaftercompleting
theirdonations.Therewasnodocumentationtoshowthateitherofthedonorswascontactedby
aBCSRNtofollowupontheirreaction.

(b)TS3002SOPIrradiationofBloodComponentsstatesthatRedCellcomponents
mustnotbeleftoutofamonitoredrefrigeratorformorethan30minutes.Inordertoverifythat
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unitsaremaintainedattheappropriatetemperatures,thetimewhenaunitisremovedfromand
placedbackintomonitoredstoragemustbedocumented.YourIrradiationTimeLogfor
September29,2011,indicatesthatthreeRedBloodcomponentswereoutofmonitoredstorage
for54minutes.TheirradiatedproductsweredistributedonOctober2,2011,andSeptember29,
2011.

5.Failureofdistributionandreceiptprocedurestoincludeasystembywhichthedistributionor
receiptofeachunitcanbereadilydeterminedtofacilitateitsrecall.[21CFR606.165(a)].Forexample,

(a)Aqueryofyourfirmscomputersystemforexpiredproductswhicharenotinquarantine
andnotpreviouslyshipped,identifiedsevenunitsofRedBloodCells,FreshFrozenPlasmaor
Plateletpools.Yourfirmcannotdetermineiftheunitshavebeentransfusedordistributedsince
theyareelectronicallystillininventorybutcannotbephysicallylocated.

(b)Yourfirmidentifiedinstanceswhereafinaldispositioncouldnotbedetermined.Yourfirm
callsthesediscrepantdiscardfortrackingpurposes,thoughthetermdiscardisonlyusedfor
theelectronicdiscardandthereisnoevidencethattheproductwasphysicallydiscarded.For
example:

i.ORF000053766wascreatedonJuly8,2012,foraunitofPlateletslistedaspresent
attheUniversityDistrictLaboratory.However,theunitcouldnotbelocated.Yourfirms
attemptstofindtheunitwereunsuccessfulanditwaselectricallydiscardedasadiscrepant
discardandtheinvestigationclosedonJuly10,2012.

ii.ORF000054674wascreatedonAugust1,2012,foraunitofPlateletsandORF
000052646wascreatedonJune6,2012,fortwounitsofthawedFreshFrozenPlasmawhen
theunitscouldnotbelocatedatexpiration.TheInvestigationandCorrectiveAction
sectionsofbothORFsareblank.ORF000054674wasclosedonAugust2,2012,andORF
000052646wasclosedonJune11,2012.

iii.ORF000057006wascreatedonOctober4,2012,forthefailuretoinitiateamissing
unitinvestigationforaunitofPlatelets.Itwasdiscoveredthattheunitwasmissingon
October3,2012,buttheunithadbeenappearingontheexpiringunitreportsinceAugust
28,2012.Thecorrectiveactiondidnotaddressthemissingproductitonlycoveredthe
failuretogenerateaninvestigation.TheORFwasclosedonOctober4,2012.

iv.ORF000059424wascreatedonDecember12,2012,foranaliquotofFreshFrozen
PlasmaandPlateletsthatcouldnotbelocatedatexpirationandnocorrectiveactionwas
takenbeyondelectronicallydiscardingtheunits.TheORFwasclosedonDecember14,
2012.

v.ORF000059680wascreatedonDecember19,2012,forareturnedunitofirradiated
apheresisplateletsthatcouldnotbelocated.TheMissingUnitInvestigationformsfrom
theInventoryManagementdepartmentandBellevuelaboratory(EastsideLab)donot
indicatethatanylocationsweresearched.TheORFwasclosedonJanuary14,2013.

(c)Duringourinspection,aRedBloodCellcomponentwasidentifiedasbeinginquarantine
accordingtoanelectronicinventoryinquiryonJanuary30,2013.However,thecomponentcould
notbelocatedintheexpectedphysicalquarantinelocation.Afterthediscrepancywasidentified
byourinvestigators,asearchwasinitiatedandthecomponentwasfoundinthediscardbin.The
componenthadbeenphysicallydiscardedwithoutmaintainingarecordofthediscardasrequired
byTS5002,FinalDispositionofBloodComponents.

6.Failuretocheckinputtoandoutputfromthecomputerorrelatedsystemofformulasorother
recordsordataforaccuracy[21CFR211.68(b)].Forexample,

(a)OnJune3,2012,youidentifiedthatdonorandpatientidentificationnumbersarecarried
forwardfrompreviousoverridefunctionswhenanoverrideisperformedbythesameuser.This
causesthepatientanddonornumberstobereplacedwithincorrectidentificationnumberson
laboratoryoverridereports.OnJune8,2012,thisissuewasreportedtothecomputersoftware
manufacturer,however,youfailedtoimplementthecomputersystemworkaroundidentifiedby
them.Forexample,onJanuary6,8,and10,2013,atleastthreeunitsweremissingthePatient
numberandOrdernumberfromthePSBCTransfusionServiceLaboratoryOverrideReport.

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(b)ORF000055354documentsaproblemwheredemographicchanges,includingbloodtype,
CMVstatusandnamechangescanbelostifadifferentuserisupdatingtherecordinanother
session.OnSeptember4,2012,thisissuewasreportedtothecomputersoftwaremanufacturer,
however,youfailedtoimplementthecomputersystemworkaroundthatthemanufacturer
identified.Duringtheinspection,yoursoftwarewastestedbyBCSstaffwhoconfirmedthatthis
eventcontinuestooccurwhendemographicchangesaremadebydifferentusers.

Weacknowledgereceiptofyourwrittenresponse,datedMarch7,2013,whichaddressesthe
inspectionalfindingsontheFormFDA483issuedonFebruary15,2013.Wehavereviewedyour
responseandfinditgenerallyadequateintermsofthecorrectiveactionsplanned.However,wenote
thefollowing:

1)Theadequacyofyourresponsecannotbefullydeterminedatthistimebecausemanyofyour
correctiveactionstopreventtherecurrenceoftheviolationshavenotbeencompleted.

2)Youfailedtoprovideadateortimeframeinwhichyouplantocompleteseveralofyour
correctiveactions.

3)ThedraftprocedureReportingProblemstoVendorsandCompletionofFollowUp
providedinyourresponsetoObservation8isincompleteandseveralsectionshavebeenleftblank.

4)YousubmittedarequestforanexceptionoralternateproceduretoCBERonMarch1,2013,
regardinguseofthe(b)(4)SystemforleukocytereductionofPlatelets.Pleasebeadvisedthatproduct
cannotbedistributeduntilthesupplementhasbeenapproved.

Theaboveidentifieddeviationsarenotintendedtobeanallinclusivelistofdeficienciesatyour
facility.Itisyourresponsibilitytoensurethatyourestablishmentisincompliancewithallapplicable
requirementsofthefederalregulations.Youshouldtakepromptactiontocorrecttheviolationscitedin
thisletter.Failuretodosomayresultinadministrativeand/orregulatoryactionbyFDAwithoutfurther
noticeincluding,butnotlimitedto,licensesuspensionand/orrevocation,seizureand/orinjunction.

Pleasenotifythisofficeinwriting,withinfifteenworkingdaysofreceiptofthisletter,ofthespecific
stepsyouhavetakentocorrectthenotedviolations,includinganydocumentationofthecorrective
actionsyouhavetakenandanexplanationofhowyouwillpreventtheirrecurrence.Ifallcorrective
actionscannotbecompletedwithin15workingdays,statethereasonforthedelayandthetimewithin
whichthecorrectionswillbecompleted.

YourfirmsresponseshouldbesenttoBrendaL.Reihing,ComplianceOfficer,U.S.FoodandDrug
Administration,SeattleDistrictOffice,2221526thAvenueSE,Suite210,Bothell,Washington98021.If
youhaveanyquestionsaboutthecontentsofthisletter,pleasecontactComplianceOfficerBrenda
Reihingat4253020429.

Sincerely,
/S/
CharlesM.Breen
DistrictDirector

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