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Response:ImmediatelyafterthisobservationwasraisedbyFDAandduringtheinspection,theabovereferencedtransferscoopsandfunnelwerereplacedbystainlessscoops/funnelhavingasmoothsurface.Therearenocrevicesandroughweldsinthenewscoops/funnelandtherefore,canbecleanedmoreefficiently.PleaseseeAppendixI-aforphotosofnewscoops.Inaddition,arelevantSOP(Managementofutensils,samplingportsandgrounddrains,SMP-03-130/3.0)wasestablishedrequiringthatallothermaterialtransferringscoopsandothersuchperipheralequipment(Funnels,transferdrums,etc)usedthroughoutourentirefacilitywillbeexaminedonamonthlybasistoensuretheydonothavethesameproblemasobservedabove(SeeAppendixIb).Allotherperipheralequipmentusedinourfacilitywasfoundtobeadequate.Response:Theabovementioneddetergenthasonlybeenusedinthecleaningprocessoftheinoculationroomglassware.Itisnotusedinanyotherapplication.Duringtheinspection,theinoculationroomglasswarecleaningprocedurewasvalidatedtoprovethatthecleaningprocessanduseofdetergenthasnoimpactonthegrowthoftheinoculatedstrain.ThisvalidationwasreviewedbyFDAonsiteandfoundacceptable.Itwasdecidedinternallythattheapplicableglasswarecanbeeffectivelycleanedwithwateraloneandtherefore,wehavediscontinuedtheuseofdetergenttocleanthisglassware.Thefermentationmediaiscomposedofstarch,soybeanpowder,calciumcarbonateagarandotherwatersolubleinorganicmaterial.Nooilbasedmaterialisused.Thus,usingwatercanalsoreachthesameintendedcleaningaswhenusingthedetergent.PleaseseeAppendixIIfortheSOPwhichregulatestheuseofwaterincleaningtheinoculationroomglassware.Response:Duringtheinspection,allfacilitysamplingpoints,drainagepointsandDIwateroutletpointswerecleanedandcappedwhichwereverifiedbyFDAonsite.Theworkshopmanagerwillinspectthecleaningandintactnessofabovepointsonceamonth.ThisrequirementhasbeenaddedtotheSOPforManagementofutensils,samplingportsandgrounddrains(SMP-03-130/3.0)(SeeAppendixI-b).InthesameSOP,wealsoregulatethateverytimeaftersamplingorafterusingthewateroutletpoints,theseportsshouldbecleanedandtheendcapattached.Also,theverificationofcleanlinessofthesesampling,drainagepoints,andDIwateroutletpoints,aswellastheintactnessofthecapswillbecheckedduringinternalQAaudits.Response:Asmentionedabove,thiswascorrectedduringtheinspectionbysewingapocketontotheoutsideofalltheclothbagswhichservesasapockettoholdthebaglabel.PleaseseeAppendixIIIforthephotoaftercorrection.Response:Duringtheinspection,aCAPAlogbookwasaddedtoSOP“SMP-02-QA-131/3”whichwillallowustotrackallCAPAsthatareinitiatedandcompletedatourfacility.PleaseseeAppendixIVfortheaddedtrackinglogbook.Asmentionedabove,FDAhasreviewedthisupdatedpracticeonsiteandfoundittobeacceptable.ResponseWehavefixedtheaboveobservationsduringtheinspectionasfollows:1.Addeddraincoversattheproperangleinworkshops105and106.Inaddition,allfacilitydraincoverswerecheckedforadequacy.Nootherswerefoundtohavethesameproblemasmentionedabove.2.ThegroundbeneaththephysicalbarrierinWarehouse5and108wascorrectedtomakeitflattersothatthephysicalbarrierfitsflushwiththegroundpreventinganyopeningforpests.PleaseseeAppendixVforphotosaftercorrection.Moreover,wehaveperformedathoroughcheckandcorrectionwithinthewholefacilitytomakesuretherearenosimilarobservations.Also,wehaveaddedthecheckofthepestcontrolpracticesintoourinternalauditplan.Response:Duringtheinspection,wecorrectedtheaboveobservationbyplacingthestickerinalocationonthethermometerwhereitwillnotinhibittheanypartofthetemperaturescalefrombeingviewed.Wehavealsoperformedathoroughcheckofallthermometersandcorrectedanysimilarsituations.PleaseseeAppendixVIforthephotoaftercorrection.Response:Duringtheinspection,weaddedelectricwaterheatingdevicestobothchangingroomsofthecleanroom.PleaseseeAppendixVIIforthephotoaftercorrection.Response:Wehaveaddedthesecondsignature(Reviewer)linetotheUVlightcheckrecord,conductivity/flowratecheckrecordandallotherrecordsinthepurifiedwaterworkshop.PleaseseeAppendixVIIIfortheupdatedrecords.AppendixI-a:Pictureofnewscoops/funnelCleanroomscoopCleanroomscoopExtractionworkshopscoopWorkshop101scoopsandfunnelAppendixI-b:SOPrelatedtothemaintenanceofutensilsusedinmanufacturingTitle:Managementofutensils,samplingportsandgrounddrains4.1checkofutensils:utensilsdirectlycontactmaterialshouldbekeptcleanandintactwithoutrustingorothermaterialthatcouldbecarriedoverintoproduct.4.5Headofplantortheassignedpersonshouldexamineallutensilsandmaterialcontactperipheralequipmentatleastonceamonthtoensurethattheyareingoodstatus.Anyfindingsshouldbecorrectedimmediately.Thisinspectionisrequiredtoberecordedinthefollowingtable.InspectionrecordtableDateUtensilnameFindingCheckerAppendixII:SOP“Procedureforglasswarewashingintheinoculationroom”Pleaseseethefollowingpageforthetranslationofthissection.Translation:4Content4.1Continuetofillinthetriangleglasswareandeggplantshapedbottlewithtapwatermorethan20minutes.4.2Useacleanbrushtofullycleantheinsideoftheglassware.4.3Rinsethebottlewithtapwateruntilnovisibleforeignmatterandnodropsofwatercanbeseenonthewall.Then,rinseitwithpurifiedwaterthreetimes.4.4Placecleanedglasswareintotheoventodrypertherequireme