国内酸化低酸食品危害分析(英)1-6(中文)

国内酸化和低酸罐头食品食品和药物治理局合规打算手册程序7303.803A目标食品和药物治理局合规打算手册程序7303.803A目标:执行日期国内酸化和低酸罐头食品收到之日起(FY03/04/05)完成日期9/30/05数据报告产品代码产品/(PAC)工业:02-11,13-41,45-46,50检查报告时间在以下PAC系统:使用适宜的产品代码03803A酸化食品/低酸食品〔AF/LACF〕查03803无标罐头打标和装箱中心安排仓库LACF/AF仅对污染物检查留意:PAC03F103AF/LACF直接检查。附加检查0384203842H附加国内鱼或鱼类产品的GMPsHACCP局部海产品检查2100221005药用食品附加检查查)21006婴儿配方奶粉附件检查报告样本分析在以下PAC系统:03803A AF/LACF至本部的现场报告A.发送以下完整报告至:食品和药物治理局CFSAN/DomesticBranch,HFS-6075100PaintBranchParkwayCollegePark,MD20740-3835遵循整体的建立检验报告〔EIR〕和在紧急许可证治理下的相关公司往来信函。EIR和其他相关公司往来信函应被考虑为临时紧急许可。警告信推举-整体的EIR和其他往来信函附加警告信用于审查。*警告信的考虑–EIR伴随考虑的总结局部/国内分支后(HFS-607),行政区将备有目标用于囊括在行政区发行的警告信。*分析耐热性争论分析试验:当培育被送到东南区试验室〔SRL〕时通过邮件通知国内分局,HFS-607。东南区试验室(SRL)分析试验:依据耐热性争论的程度，送:原始分析工作底稿(FDA431)至母行政区。如不同行政区，FDA431的复印件至效劳试验室。检查*发送以下完整报告至:食品和药物治理局CFSAN/ComplianceProgramBranch,HFS-636ATTENTION:DOMESTICLACFMONITOR5100PaintBranchParkwayCollegePark,MD20740-3835**EIRIII，A.6.,对高压杀菌系统的审查使用微处理器或计算机掌握和生成热处理或临界因子掌握。*检查可使用以下任一技术:蜊汤，块状汤或炖菜等。可用媒介;数字温度计替代水银玻璃温度计;公司的初始检查除用高压杀菌方法处理和无菌包装脉冲电场，放射方法。培训和询问参与更好的过程掌握学校-详情见局部III,发送完全报告至:食品和药物治理局CFSAN/DomesticBranch,HFS-607ATTENTION:BPCSProgramManager5100PaintBranchParkwayCollegePark,MD20740-3835事实–数据报告检查更好的过程掌握学校FDA员工报告遵循操作代码83资源花费分析果。除报告分析结果外，在“违规样本数据筛分”下被定义为试验级“3”的样本的所需数据必需被完成。局部I–背景品州际贸易安排可能导致对安康的危害。21CFR113密封器皿低酸食品热加工“21CFR114“酸化食品“对*制造，加工和包装食品*的*要求*是防止*产生肉毒杆菌环境，其毒性会引起潜在致命性食品中毒既罐头食品中/养分有利于这些细菌的生长并产生毒素。*出了上述要求外21CFR108紧急许可证治理“需要低酸罐装食品FDA并附着良好产品标准(GMPs)中描述的强制要求。*108,113和114中的强制要求“应”在引介其21CFR局部108分部B许可的特别需求和条件的豁免”要求的紧急许可证。局部II–执行目标21CFR,108“紧急许可证掌握“,21CFR113“密封器皿低酸食品热加工21CFR114酸化食品“,和其他食品，药品和化装品(FD&C)法的要求。为防止州际市场的酸化和低酸罐装食品不在这些要求条件下生产。*留意:外国LACF21CFR,108“紧急许可证掌握“,21CFR113“密封器皿低酸食品热加工“21CFR局部114酸化食品“,和其他食品，药品和化装品(FD&C)法的强制规定，当检查外国产品时在这一生产合格性程序使用同样的指导。*打算治理指导总论加工和检查中间或需要专业技术，应遵守在附件A定义的警告系统流程显得极其重要。在或马上觉察严峻的违反法规或的检查后或跟踪产品故障/召回报告指出在加工系统或操作加工中的严峻错误，HFS-607必需被马上A。不要把宠物或动物食品囊括于此程序。意识到公司使用一些种类的番茄加工可能导致番茄和番茄产品PH4.7(21CFR114.3(d)).自然发酵产品不被考虑作为酸化食品。自然发酵产品是指那些：已经被盐化或被放入盐水中溶液;和PH4.6的产品;和在没有使用其他附加酸后发酵到达低于4.6PH值的产品。NOTE:某些酸可能在发酵处理前被参加用于掌握发酵。4.6PH值的食品发酵。这通常指的是乳酸发酵。泡菜,腌黄瓜，花椰菜和茴香叶泡菜都是自然发酵产品的例子。低酸食品是指那些被“发酵的”并且在发酵后PH值大于4.6和活度大于0.85.食品局部发酵但要求额外的酸用于削减PH值至4.6足以削减PH值至4.6或更底，这样的产品就是酸化食品。发酵后和添PH值，并做酸化过程检查。PH值。假设PH4.6，它就是低酸食品并必需被作为低酸罐假设有关于产品是否是发酵产品的问题被提出,那么就应取样产PH值的历史记录。工和储存，微生物或电子技术。CFSAN/领域规划局/合规分支,HFS-636将对国内酸化/低酸罐头食品发行打印件。行政区可使用这些打印件为月底被发行。优先掩盖检查优先权应被考虑如下方法治理:/或低酸罐装食品制造商应被在六个月内通知检查。留意:注册公司的信息或现有注册信息的更改将被用电子邮件送至检查部门主任(DIB)。全部在紧急许可证下的或被分类为“指示为官方行动(OAI)的酸化12月内检查。被归类为“指示为无行动(NAI)全部的酸化食品和/或低酸罐装食36月内检查。与其他程序的互动国内食品安全程序(7303.803)报告那些不能标签的“罐头”被运输用于打标和包装违反PAC03803中LACF/AF程序相关那么完全检查就应遵循食品安全程序被执行。〔指定在变应原任tGof7303.803)为一个变应原检查那么就应考虑全面变应原检查。DomesticFishandFisheryProductsInspectionProgram(7303.842)TheseafoodHazardAnalysisandCriticalControlPoints(HACCP)regulations21CFRPart123“FishandFisheryProducts“becameeffectiveDecember18,1997.Theseregulationsrequire,amongotherthings,thatallseafoodbeprocessedunderaHACCPsystem.ItisnotnecessaryforaproperlyregisteredLACFprocessorofseafoodtoaddresscontrolsforthealreadyaddressedunderLACF.However,theprocessor”sseafoodHACCPplanmustcontrolotherhazardsassociatedwiththesecannedseafoods.(e.g.,thehazardofhistaminetoxinincannedtunaandotherhistamineformingspeciessuchasmackerel,sprats,anchovies,etc.)InvestigatorsmustcompletetheSeafoodHACCPInspectionReportfortheHACCPcomponentofcannedseafoodinspectionsinadditiontootherrequiredreports.(See7303.842asappropriate).Attemptto“add-on“inspectionsoffisheryproductfirmwhenconductingapplicableLACFinspections.RecordbothPAC03803AandtheapplicableDomesticSeafoodPACasperCP(7303.842)whenbothtypesofinspectionsareconducted.MedicalFoods-ImportandDomestic(7321.002)RefertotheinspectionschedulethatisissuedseparatelyeachyearbyCFSAN/DFP.Attemptto“add-on“LACFinspections,ifapplicable.RecordbothPACs03803Aand21002whenbothtypesofinspectionsareconducted.InfantFormulaProgram-ImportandDomestic(7321.006)RefertotheinspectionschedulethatisissuedseparatelyeachyearbyCFSAN/DFP.Attemptto“add-on“LACFinspection,ifapplicable.RecordbothPACs03803Aand21006whenbothtypesofinspectionsareconducted.NLEAandGeneralFoodLabelingRequirements-Domestic(7321.005)ThisComplianceProgramreflectsthecurrentNLEAinstructions.ReportallresourcesexpendedforNLEAunderPAC21005.LabelingissuesregardingundeclaredfoodsandallergensshouldbereportedunderthisprogramaccordinglyPARTIII-INSPECTIONALConsulttheDomesticFoodSafetyProgram(7303.803)concerningpesticides/chemicalcontaminantsandfood/coloradditives.INSPECTIONALPlantRegistration/ScheduledThermalProcessFilingNOTE:LackofPlantRegistrationand/orfailuretofileprocessesarereportableitemsonFDAForm483.AppropriateFDA483entriesregardingfailuretoregisterandfileinclude:Instanceswherethefoodiseasilyrecognizedasanacidifiedfood,(e.g.,freshpackpeppers)andfailuretoregisterandfilehaveoccurred.InstanceswherethestatusofthefoodcanbedeterminedthroughcontactwithCFSAN,Supervisory,ComplianceorORAexpertstobeacidifiedorLACFpriortotheconclusionoftheinspection.Caseswherethestatusofthefoodmayhavetobedeterminedthroughlaboratoryanalysisorevaluationoftheformulation.Thefirmshouldbeinformedthatthefoodhasbeendeterminedafterreviewtobeanacidifiedfoodandthatthefirmshouldregisterandfilethescheduledprocessforthatproduct.InanyoftheabovementionedeventsthefirmshouldbeinformedthatitistheirresponsibilitytodetermineiftheproductstheymanufacturefallundertheAcidifiedorLow-acidCannedFoodregulationsandfileandregisteraccordingly.UsetheLow-AcidCannedFood(LACF)On-LineComputerSystemtodeterminewhether:themanufacturerhasregistered/FCEnumber,aprocess(es)hasbeenfiledfortheproduct(s),and/ortogaininformationaboutfirm”sthermalprocessinpreparationfortheinspection.NOTE:Acopyoftheregistrationformshouldbeobtainedpriortoandincludedintheinspectiontoensurefilingandregistration.TheCenter”sLACFRegistrationCoordinatorprovideseachdistrictwithcopiesofallthefirm”sregisteredforthatDistrict.IftheLACFsystemisdown,theDistrictcanconsultitsownregistrationfiles.Thesamedoesnotholdtrueforprocessfiling.Referbelowforfurtherinstructions.Thison-linecomputersystemwasimplementedintheFieldduringFYPersonnelrequiringaccesstothissystemlocatedattheDivisionofComputerResearchandTechnologyattheNationalInstituteofHealth(NIH)mustobtainanaccount.MichelleBaucumat(301)827-1537isORA”scontactfornewandexistingaccountsforFieldPersonnel.AllCenterforFoodSafetyandAppliedNutrition(CFSAN)usersrequiringanaccountshouldcontactKristineKrebsandexistingCFSANaccountusersshouldcontactSharonMacuci,CelinesRoberts,orYanmeiLiu.OnceanORAaccountiscreated,Ms.BaucumnotifiesCFSANpersonnelandtheadditionalrequirementstogainaccessaregrantedbyCFSANpersonnel.MichellecontactsallORAuserswithafollowupfromCFSANforaccountstatusuponcompletion.NOTE:ORApersonnelrequiringapasswordfixcontactMichelleBaucum;CFSANstaff,contactSharonMacuci.Foranyothersystemproblems,contactSharonMacuciat(301)436-1865.g.IftheFCEnumberisnotprovided,todetermineifamanufacturerhasregistered,selectmenuitem1)forRegistrationfile.Thefilemaybesearchedusingthemanufacturer”sname.Firmsmustregisterbyactualprocessingplantname.h.Ifthemanufacturerisregistered,todetermineiftheprocesshasbeenfiledfortheproduct(s),containertype(s),andcontainersize(s),thefollowingoptionsshouldbefollowedasappropriate.SelectMenuitem4)forImports-todetermineiftheprocessisonfilefortheproduct,containertypeandcontainersize.SelectMenuitem5)forDomestic-todetermineiftheprocessisonfilefortheproduct,containertypeandcontainersize.SelectMenuitem9)todetermineiftheprocessisacceptedforfilingbutnotreferencedunderMenuitem4or5.SelectMenuitem3)todetermineiftheprocesshasbeensubmittedtoFDAbutis:Stillunderreview;Hasbeenreturnedtofirmrequestingmoreinformation;orThemanufacturerhascompliedwiththefilingrequirementasevidencedbyadateinthereadyfieldbuttheinformationhasnotbeenupdatedtotheMasterFile.SelectMenuitem6)todetermineimportestablishmentproductdetentions.Ifthefirmtobeinspectedhasnoprocessesfiledortheproductofconcernisnotlistedandallthereferencedmenuitemsabovehavebeenchecked,contacttheLACFRegistrationCoordinator(HFS-618)forassistanceat(301)436-2411.TheMenuitemslistedaboveareupdatedcontinuously.ContactCelinesRobertsorSharonMacucitoobtainanelectroniccopyofthefirm”sprocesses.Allfiledprocessesforthefirmwillbeprovided.Pleaseallowatleastonetotwoweeksnoticepriortoinspectiontoreceivethefiledprocessesforthefirm.PleaseprovidetheFCEnumber,firmnameandaddressandtheFEInumber.IftheFCEnumberisnotprovided,thisprocessmaytakelongertoinvestigatewhetherthefirmislistedinthedatabase.CFSANwillnotifytheindividualrequestingthefilingsdirectlywithallrequestedinformation.Ifuponinspection,thefirmhasmovedlocation,themanufacturermustnotifyCFSANofthemoveandre-registerandfileprocessinformationforthenewlocation.ForfirmswithnoaccesstotheInternet,providecopiesofFormsFDA-2541andFDA-2541aorFDA-2541c(asappropriate)alongwiththeinstructionbooklet.Citetherequirementsof21CFR108.25(c)(1)“AcidifiedFoods-Registration“and21CFR108.25(c)(2)“AcidifiedFoods-ProcessFiling“or21CFR108.35(c)(1)“Thermalprocessingoflow-acidfoodspackagedinhermeticallysealedcontainers-Registrationandprocessfiling-Registration“and21CFR108.35(c)(2)“Thermalprocessingoflowacidfoodspackagedinhermeticallysealedcontainers-Registrationandprocessfiling-Processfiling“asappropriate.SecurityofInformationProvidedintheLow-AcidCannedFoodOn-LineComputerSystemDuetotheconfidentialinformationcontainedintheLACFProcessFile,specialprecautionsmustbetakentoensuresecurityofthedatageneratedfromthesystem.Theprocessfilingfacsimilesgeneratedfromthissystemmustbehandledwithdiscretion,securedwhennotinuse,anddestroyedinanappropriatemannerwhennolongerneeded,i.e.:OnlyFDAemployeesandthefirmbeinginspectedcanviewtheirfacsimilesandreports.Thesereportsmaynotbecopied,excepttobeprovidedtotheinspectedfirmifrequestedduringtheinspection.FollowFDA”sregulationsandproceduresregardinginformationdisclosurewhenconsideringwhethertodisclosetheinformationtoapersonoutsideFDA.Thesereportsmaybeplacedinthefactoryjacket,inthesectionthatisidentified“notforpublicinformationordistribution“iftheyaretoremainaspartoftheofficialfile.ReportsgeneratedinerrororarenolongerusedbytheDistrictmustbedestroyed.InspectionsNOTE:CFSANhasdiscontinuedtheuseof“targeted“or“directed“inspectionsdueto“NoActionIndicated“(NAI)firmsnolongerrequiringannualinspections.Onlythesefirmswillbeinspectedonathree-yearcycle.ReportallLACF/AFinspectionusingPAC03803A.Form3511-1,TargetedInspectionReport,isbeingremovedfromORA”sformssite.ReportallLACF/AFinspectionsusingthefollowingforms,asappropriate.TheFormsareavailableonFieldOperationsForms1site.TheformsareinMSWORDformatandcanbeelectronicallycompletedafterdownloading.Thereportformsconsistofcoresthatcanbeexpandedtowhateverlengthnecessary.Theformsare:. FDAForm3511FDALACFInspectionReportFDAForm3511a-iRetortReportingForms-seebelow,asappropriateFDAForm3511-2AcidifiedFoodInspectionReportFDAForm3511-3AsepticFoodInspectionReport(currentlyunderfinalreview).Itwillbeavailableontheformssiteuponcompletion.RetortReportingforms:3511aProcessinginSteaminStillRetorts3511bProcessinginWaterinStillRetorts3511cProcessinginSteaminContinuousAgitatingRetorts3511dProcessinginSteaminDiscontinuousAgitatingRetorts3511eProcessinginWaterinDiscontinuousAgitatingRetorts3511fProcessinginSteaminHydrostaticRetorts3511gProcessinginCascading/SprayWaterRetort3511hProcessinginSteam-AirRetorts3511iProcessinginOtherUniqueRetortSystemsUseFDAForm3511andtheappropriateRetortReportingForm(FDAForms3511a-i)asaguidetotheconductoftheinspection.Focusasnecessaryonthefollowingwheninvestigationrevealsthatmajorchangesintheprocessorsignificantdeviationsfromthescheduledprocesshaveoccurredsincethelastinspection.m.ScheduledProcessDetermineifthescheduledprocess(es)haschangedsincethemostrecentinspection.Majorchangesinclude:Changesinprocessingmethods(e.g.,stilltoagitating,etc.),changesincontainertypes(e.g.,metaltosemi-rigid,etc.),additionofnewproductlines,etcIfthescheduledprocess(es)haschanged,determinewhetheroldprocesseshavebeencanceledandnewprocessesfiled.DescribeanddocumentfullextentofchangesusingFDAForm3511.DeliveryoftheScheduledProcessDetermineiftheretorts,retortcontrolsystems,containerfillingandhandlingequipment,andventingconditionshaveremainedthesamesincethelastinspection.Ifnochanges,ageneralvisualinspectionoftheequipmenttoidentifygrossdeviationsfromtheregulationsissufficient.Iftheretortsystemand/orothercriticalequipmenthavechangedsignificantly,describeanddocumentfullextentofchangesusingappropriateRetortReportingForm(FDAForms3511a-i)orFDAForm3511asnecessary.Ifsignificantdeviations(e.g.,brokenMIG,etc.)arenotedduringthevisualinspection,describeanddocumentfullextentofdeviationsusingappropriateRetortReportingForm(FDAForms3511a-i)orFDAForm3511asnecessary.DocumentationofProcessDeliveryDeterminethatrecordstodocumentdeliveryofthescheduledprocessandcontrolofcriticalfactorsarebeingcreatedandmaintained.Conductarandomauditoftherecordstodeterminethatthescheduledprocessisbeingdeliveredandthatcriticalfactorsareundercontrol.Ifanauditrevealsdeviationsfromthescheduledprocessorlackofcontrolofcriticalfactors,audittheseparateprocessdeviationlogorfile.Ifthedeviationlogorfileindicatesimproperhandlingofdeviations,describeanddocumentfirm”sfailuretocomplyincompletedetailusingFDAForm3511.ContainerIntegrityDocumentwhetherornotthefirmisconductingappropriatevisualanddestructiveteststoassesscontainerintegrity.Auditcontainerintegrityexaminationrecordstoensurecontainerseamsorsealsarewithinspecifications.Auditcontainerhandlingequipmentandprocedures(tracks,conveyors,crates,etc.)toensurecontainerintegrityisnotcompromised.GeneralDetermineifappropriateplantpersonnelhavebeentoaBetterProcessControlSchool(BPCS).Documentwhetherornotthefirmhasarecallplanonfile.Formoreinformationontheinspectionoflow-acidcannedfoodandacidifiedfoodreferto:21CFRParts1082,1133,1144FormFDA482a-WrittenDemandforRecords.RefertotheFDAGUIDETOINSPECTIONSOFLOWACIDCANNEDFOODMANUFACTURERS,Part1-AdministrativeProcedures/ScheduledProcessed,November1996forspecificguidanceofuse.FormFDA482b-WrittenRequestforInformation.RefertotheFDAGUIDETOINSPECTIONSOFLOWACIDCANNEDFOODMANUFACTURERS,Part1-AdministrativeProcedures/ScheduledProcessed,November1996forspecificguidanceofuse. FDAGUIDETOINSPECTIONSOFLOWACIDCANNEDFOODMANUFACTURERS,Part1-AdministrativeProcedures/ScheduledProcesses5,November1996.FDAGUIDETOINSPECTIONSOFLOWACIDCANNEDFOODMANUFACTURERS,Part2-Process/Procedures6,April1997.FDAGUIDETOINSPECTIONSOFLOWACIDCANNEDFOODMANUFACTURERS,Part3-Containers/Closures7,November1998FDAGUIDETOINSPECTIONSOFACIDIFIEDFOODMANUFACTURERS8,May1998FDAGUIDETOTHEINSPECTIONOFASEPTICPROCESSINGANDPACKAGINGFORTHEFOODINDUSTRY9FEBRUARY2023FDAGUIDETOTHEINSPECTIONSOFCOMPUTERIZEDSYSTEMSINTHEFOODPROCESSINGINDUSTRY10MARCH1998Anacidfoodthatcontainsasmallamountoflow-acidingredient(s)andhasanequilibriumpHthatdoesnotdiffersignificantlyfromthepHofthepredominantacidoracidfoodingredient(i.e.,formulatedacidfood)isnotcoveredunder21CFR114“AcidifiedFoods“.Examplesofformulatedacidfoodsaresomesalsas,dressings,andcondimentsauces.NOTE:AppropriateFDA483entriesregardingfailuretoregisterandfileinclude:Instanceswherethefoodiseasilyrecognizedasanacidifiedfood,(e.g.,freshpackpeppers)andfailuretoregisterandfilehasoccurred.InstanceswherethestatusofthefoodcanbedeterminedthroughcontactwithCFSAN,Supervisory,ComplianceorORAexpertstobeacidifiedorLACFpriortoconclusionoftheinspection.Caseswherethestatusofthefoodmayhavetobedeterminedthroughlaboratoryanalysisorevaluationoftheformulation.Thefirmshouldbeinformedthatthefoodhasbeendeterminedafterreviewtobeanacidifiedfoodandthatthefirmshouldregisterandfilethescheduledprocessforthatproduct.InanyoftheabovementionedeventsthefirmshouldbeinformedthatitistheirresponsibilitytodetermineiftheproductstheymanufacturefallundertheAcidifiedorLow-acidCannedFoodregulationsandfileandregisteraccordingly.Todeterminewhetherthesmallamountsoflow-acidingredient(s)resultinasignificantpHdifference,obtain:. Quantitativeformulation(obtainquantitativeinformationusingthesameunitsofmeasurementorpercentages).ThepHofeachingredientinthequantitativeformulationiffeasibleORotherevidencethatdetermineswhetheringredientsbeingusedareacidorlow-acidcomponents(i.e.,rawchoppedvegetablesusedasingredient(s)).Completedescriptionoftheformulationprocess(howingredientsareprocessedandformulatedtogether).ThepHoftheacid(s)and/oracidfood(s)ingredientsmixedtogetherinthesameproportioninwhichtheacid(s)and/oracidfood(s)ingredientsappearintheproductformulation.Relatethesesamplestothemixedacidingredient”spHandtheindividualingredient”spHlevels.ThepH(minimumofsixunitswhenobtaininginformationtodetermineifproductiscovered)ofthefinishedproduct(obtainfromthefirm,ifavailable,orthroughsampling).FinishedproductscollectedtodeterminepHforthepurposeofsupportingregulatoryactionshouldbecollectedperIOMchapter411“SampleScheduleChart2“.SubmittheinformationtoCFSAN/DivisionofEnforcement/DomesticBranch(HFS-607)forreviewtodetermineifthereisasignificantdifferencebetweenthepHofthefinishedproductandthepredominantacid(s)oracidfood(s).ComputerControlsWhenretortingsystemsusemicroprocessorsorcomputerstogeneraterecordsofprocessingand/ortocontrolthermalcriticalfactors,collectthefollowingdataandinformationonthesystem:informationonequipmentspecifications(softwareandhardware),whatcriticalfactor(s)arecontrolledandrecorded,howcriticalfactor(s)arecontrolledandrecorded,howthefirmensuresthatthemicroprocessororcomputerareindicatingthecorrectinformation,howoftentheequipmentiscalibratedand/orcheckedforaccuracy.ThisinformationandthecompleteEIRshouldbesubmittedtoCFSAN/ComplianceProgramBranch,HFS-636forreviewbyCFSAN/DivisionofHACCP/RegulatoryFoodProcessingandTechnologyBranch(HFS-617).ContractPackersBeawareofthefirm”suseofacontractoroff-sitepackagingoperation(e.g.,shrinkwrapsleeves).Containerdamageintheformofcontainer“slits,splits,holes,punctures“mayoccurtothecontainersduringhandlingatthesepackers.Thistypeofdamagecanoccurastheresultofopening“master“containercartonswithsharpcaseknivesratherthanusingcasepaddles.Two(2)piece“lightmetalcans“(e.g.,thingaugetin/steel;oraluminumaremoresusceptibletothistypeofcontainerdamagethansturdiermetals.Districtsattheiroptioncanperformcanexaminationsoftheproductmanipulatedbytheidentifiedcontractoroff-sitepackagerusingIOM,Chapter4,SampleScheduleChart2,“SamplingScheduleforCannedandacidifiedFoods“todeterminethenumberofcanstoexamineinalot.SAMPLINGIOM,SampleScheduleChart212,“SamplingScheduleforCannedandAcidifiedFoods“,listssamplinginstructions.Routinelyexaminewarehousestockforevidenceofabnormalcontainers.Ifabnormalcontainersarefound,theinvestigatormustreportlotsize,numberofcontainersexamined,andnumberofabnormalcontainersfoundbythetype(e.g.,hardswells,etc.).Estimatethepercentageofabnormalcontainersinthelot.TheseabnormalitiesshouldberecordedonformFDA483perIOM,Chapter5,EstablishmentInspection,ReportableObservations.LACFProducts:Ifunder-processingorimportantcontainerintegrityproblemsarefoundorsuspected,conductwarehouseexaminationsofsuspectcodes.Ifboththermalprocessingdeviationsandcontainerintegrityproblemsexist,giveprioritytoexamininglotsinvolvingthermalprocessingdeviations.Collectexamplesofalltypesofabnormalcontainersandallcontainerdefects.Forproductspreservedthroughcontrolofwateractivity(aw)orsalt,collectanadditionalsix(6)normalcontainersfromsuspectcodeswhenrecordrevieworinspectionalevidenceindicatesafailuretoadequatelycontrolaworsalt.Examplesofaworsaltcontrolledfoodsare:bread,beanpaste,saltedfishorvegetables,someorientalsaucesandLupinibeans.AcidifiedProducts:IfevidenceindicatesfailuretoadequatelycontrolpH,collectsamplesofsuspectcodesforpHdeterminationperIOMSampleScheduleChart2.Forcontainerslargerthan795grams(e.g.,28ounces)netweight,usethesamplesizefor#10cans.(603x700sizecans).Forallothers,usethesamplesizefor#21/2cans.Ifthereisanydoubtwhethertheproductisacidified,collectinformationasperIII.A.3.Inaddition,ifthefirmappearstohavedeviationsfromitsscheduledprocess,whichcouldresultinpHlevelsabove4.6,collectsamplesfromseveralsuspectlots.LACFandAcidifiedProducts:Ifproblemsaresuspected,butnoabnormalcontainersarefound,collectionofnormalcontainersforsurveillancesamplesisoptional.ALERTSYSTEMBecauseoftheserioushealthhazardsresultingfromimproperlyprocessedLACF/AFandtheoccasionalnecessityforexperttechnicaladviceduringaninvestigation,itisimperativethattheAlertSystemproceduresasdefinedinAttachmentAbefollowed.DuringorIMMEDIATELYafteraninspectioninwhichsignificantdeviationsfromtheregulationareobservedorwherefollow-uptoreportsofproductfailures/recallsindicateaseriousfailureinaprocessingsystemoroperatingprocedure,HFS-607mustimmediatelybecalled,perAttachmentA.BETTERPROCESSCONTROLSCHOOLSTheBetterProcessControlSchool(BPCS)programisacooperativetrainingprogrambetweentheuniversitiesthathavebeenapprovedbytheCommissionerforgivingBPCSinstruction,theFoodProcessorsInstitute(FPI)andtheFDA.FDAparticipantsshouldbeexperiencedLACF/AFinvestigatorsandfamiliarwiththeLACFandAcidifiedFoodregulations.FDAparticipantsareexpectedtobeinattendanceandavailablethroughouttheBPCS.FromthebeginningFDAhasbeenresponsibleforprovidinganFDAparticipantto:Presentanintroductionthatgenerallyfocuseson:Theimportanceofthecourse,andHighlightsoftheregulations.AnswerquestionsProvidesupporttotheuniversitymanagerandinstructors.Whennecessary,providesomeoftheinformationnecessaryforFDAtodetermineapprovalofanewuniversitythatproposestobeginofferingtheBPCStrainingprogram.ProvidefeedbacktoCFSANintheformofawrittenreport:Thekindsofquestionsthatarise,Newinformationthatmightarisefromclassdiscussion,Anyunanticipatedproblems.NOTE:AlldistrictswereprovidedwithavideotapedintroductionforBPCSsometimeagobyDivisionofFieldInvestigations(DFI).IfyoucannotlocatethistapeinyourdistrictandwouldlikeacopypleasecontactDFI.REPORTINGFACTSREPORTINGReportwarehousestockexaminationsconductedduringinspectionsaspartoftheinspectionnotasa“FieldExam“.Reportasa“FieldExam“,onlyifexaminationofsuspectedlotswereconductedatconsigneesandnosampleswerecollected.UsethefollowingPACsforspecificoperationsand/oradd-oninspections:PAC Description03803AAF/LACFfullinspections03803 Inspectionsofcentraldistributionwarehouseswhereunlabeledcansareshippedforlabelingandcasing;andfollow-upinspectionsofLACF/AFproductsforfilth,only03842 Add-ondomesticfishorfisheryproductsforGMPs03842HAdd-onSeafoodHACCPportionofaninspection21002 Medicalfoodadd-oninspections21005 NLEA:CoverageofNLEAwillbeaccomplishedduringALLroutineinspectionsconductedundertheDomesticAcidifiedandLowAcidCannedFoodsprogramforfirmsthataremanufacturingand/orlabelingorre-labelingfoodproductsatthesitebeinginspected.DonotreportinspectionsunderNLEA.SeecurrentNLEAcomplianceprogram(CP7321.005)forcompleteguidance.21006Infantformulaadd-oninspectionsuseofPAC03F103AF/LACFDirectedInspections.BetterProcessControlSchools.ReportresourcesexpendedbyFDApersonnelunderOperationsCode83.HardcopyreportingtoCFSAN/ComplianceProgramBranch,HFS-636EntireEIRandinformationidentifiedinPARTIII,A.6.,forreviewofretortingsystemsusingmicroprocessorsorcomputerstocontrolandgeneraterecordsofthermalprocessingorcriticalfactors.EntireEIRandanyrelatedmaterialsforLACFinspectionsofanyofthefollowingtechnologies:AsepticallyprocessedandpackagedLACFproductscontainingparticulatefood,e.g.,clamchowder,chunkysoupsorstews,etc.;Sterilizationofasepticpackagingmaterialsusingmediaotherthansuperheatedsteamorhydrogenperoxide;Digitalthermometersinlieuofmercury-in-glassthermometers;Anynewcanningtechnologybeinginspectedforthefirsttime.PARTIV-ANALYTICALANALYZINGLABORATORIESConsulttheServicingLaboratoriesTable,AppendixIII,andORAFieldWorkplanforlaboratorycapability/servicingareainperformingthefollowinganalyses:pHDeterminationMicrobiologicalandPhysicalExaminationofContainerStaphylococcalenterotoxinHeatResistanceDeterminationHeadspaceGasAnalysis