FDA审计的缺陷信为什么叫483警告信？

2.483和警告信(warningletter)不是一个东西。483是“InspectionalObservations”，这份表格编号是“FormFDA483”.这一点，SunnyGao已经解释过啦~所以，针对题主的问题，为什么叫483？就因为这个表格编号是form483...另外，因为题主问混淆了483和警告信，所以我觉得有必要简单说说，这两个货不是一个东西啊~~弄错了要出大事的啊(比如，要被老板骂的啊)~483和警告信的发起时间、公开程度以及回复的要求是不一样的。对于483：FDA检察官在检察(inspection)中，如有任何观察项(Observation)，则会当场出具FDA483表。此处不要以为观察项(Observation)是建议项(suggestion/opportunityforimprovement)或者轻微不合格(minornonconformity)。开了483，一般都是发现了很严重的不合格项。FDA对483的定义是(摘自wiki)：FormFDA483TheU.S.FoodandDrugAdministration(FDA)isauthorizedtoperforminspectionsundertheFederalFood,Drug,andCosmeticAct,Sec.704(21USC§374)"FactoryInspection".[1]FormFDA483,[2]"InspectionalObservations,"isaformusedbytheFDAtodocumentandcommunicateconcernsdiscoveredduringtheseinspections.Alsoreferredtoas"Form483"[3][4][5][6]ormerely"483",[4][7]itstatesthereonthatit"...listsobservationsmadebytheFDArepresentative(s)duringtheinspectionofyourfacility.Theyareinspectionalobservations,anddonotrepresentafinalAgencydeterminationregardingyourcompliance"Arecipientofa483shouldrespondtotheFDA,addressingeachitem,indicatingagreementandeitherprovidingatimelineforcorrectionorrequestingclarificationofwhattheFDArequires.[4]Thisresponsemustbesubmittedwithin15businessdaysregardlessofthenumberofobservations,asofSeptember2009.[8][9]Whilearesponseisnotcompulsory,agoodresponsecanusuallyhelpacompanyavoidreceivingaWarningLetterfromtheFDA,[3]withholdingofproductapproval,orplantshut-down.[6]Mostexpertswarnthatresponsesshouldbecomprehensive,well-reasoned,well-documentedandtimely,andthateachobservationshouldbeaddressedindividually.[10]另外，FDA官网针对483的常见问题Q&A请点击下方传送门：FDAForm483FrequentlyAskedQuestions对于公开程度，483一般是不公开的，只有企业自己收到。除非FDA认为有必要，会在FDA官网公开部分483。另根据美国的信息自由法案(FreedomofInformationAct)向FDA要求公开483。收到483后，要确保在15个工作日内书面回复，如果回复被FDA认可，则不会上升为警告信。关于警告信的信息如下：警告信(WarningLetter)FDA警告信的定义：用以通知被监管者在FDA的检查中或调查中有被记录在案的违法事实的一种信件。如果FDA认为企业对483的回复不充分，FDA会开警告信。警告信是公开在FDA官网的，所有人都可以看到。FDA官网对于警告信查询的网址如下：WarningLettersFDA对warningletter的定义(摘自wiki)FDAWarningLetterTheUnitedStatesFoodandDrugAdministration(FDA)definesaWarningLetteras"...acorrespondencethatnotifiesregulatedindustryaboutviolationsthatFDAhasdocumentedduringitsinspectionsorinvestigations.Typically,aWarningLetternotifiesaresponsibleindividualorfirmthattheAgencyconsidersoneormoreproducts,practices,processes,orotheractivitiestobeinviolationoftheFederalFood,Drug,andCosmeticAct(theAct),itsimplementingregulationsandotherfederalstatutes.WarningLettersshouldonlybeissuedforviolationsofregulatorysignificance,i.e.,thosethatmayactuallyleadtoanenforcementactionifthedocumentedviolationsarenotpromptlyandadequatelycorrected.AWarningLetterisoneoftheAgency’sprincipalmeansofachievingpromptvoluntarycompliancewiththeAct.[1]收到了警告信，对于外国制造商，至少就不能美国市场继续销售产品了。这个时候大家想，美国不让卖还有其他好多国家嘛~~Tooyoung,Toosimple。警告信是全球都可以看到的，公司的名誉瞬间下滑，还有好多国家卫生部门会在看到警告信后，也将这家公司的产品列入禁止进口名单。这才是警告信可怕的地方~~就酱。