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文章题目：被FDA认为是假药！某公司收到FDA警告信（全文）
原文作者：julia朱玉姣
正文：
前几日，海正药业对FDA的警告信内容发表过声明，详见《海正药业：关于FDA对台州工厂原料药检查出具警告信的公告》 FDA官网发布对浙江海正警告信，签署日期为2015年12月31日。 =================== FDA在2015年3月2-7日检查了你们在Zhejiang HisunPharmaceuticalCo., Ltd., 46 Waisha Road, Jiaojiang District, Taizhou City,Zhejiang Province的生产场所。 这些偏差导致你们的药品根据联邦食品药品和化妆品法案21 U.S.C. 351(a)(2)(B)第501(a)(2)(B)条，“其生产、加工、包装或存贮所用方法、设施或检测不符合GMP”，被认为是假药。 我们已经详细审核了你们于2015年3月27日给出的回复，也收到了之后的回复。
我们的调查员在检查中发现了一些问题，包括但不仅限于以下： 未能防止不经授权获取或更改数据，未能提供充分的控制以防止数据被篡改及数据遗失。 During the inspection, FDA investigators discovered a lack ofbasiclaboratory controls to prevent changes to your firm’s electronicallystoreddata and paper records. Your firm relied on incomplete records toevaluatethe quality of your drugs and to determine whether your drugs conformedwithestablished specifications and standards. 在检查中，FDA调查人员发现缺失了基本的化验室控制，无法防止对贵公司电子存贮数据和纸质记录的更改。贵公司依赖于不完整的记录来评估你们药品的质量，决定你们的药品是否符合既定的规格和标准。 Our investigators found that your firm routinely re-tested sampleswithoutjustification and deleted analytical data. We observed systemicdatamanipulation across your facility, including actions taken by multipleanalysts,on multiple pieces of testing equipment, and for multiple drugs. Youareresponsible for determining the causes of these deviations, forpreventingrecurrence, and for preventing other deviations from CGMP. 我们的调查人员发现贵公司经常对样品进行复试，而没有相关论证，并且将分析数据进行了删除。我们在你们整个工厂都发现有数据造假现象，包括多个化验员在多种药品多个检测设备上所做的事情。贵公司有责任确定这些问题的原因，以防止同样问题再次发生，以及防止其它偏离CGMP的问题发生。 a. During the inspection, we reviewed the electronic logfor highperformance liquid chromatography (HPLC) system #36 and determinedthat theaudit trail was disabled on February 6, 2014. One of youranalysts executed 80HPLC injections for assay and impurity tests of validationstability batches (b)(4)of (b)(4) API. 在检查中，我们审核了36#HPLC系统的电子日志，确定2014年2月4日其审计追踪没有激活。贵公司一名化验员在当日进样80针，是某原料药某验证稳定性批次的含量和杂质检测。 Because the audit trail was disabled, neither your quality unit noryourlaboratory staff could demonstrate that records for these batchesincludedcomplete and unaltered data. All supporting raw data wasdiscarded,including sample solution dilutions and balance weight printouts.Sampleanalyses were not recorded in the instrument use logbook. Testresultswere deleted from the hard drive and all supporting chromatogramswerediscarded. Audit trail functions were re-enabled on February 8, 2014,andthe same analyses were repeated. You submitted the February 8th testresultsto the FDA in March 2014 in support of Drug Master File (DMF) (b)(4). 由于审计追踪被关闭，你们的质量部门和化验室员工都不能证明这些批次的记录包括的是完整未经伪造的数据。所有支持性原始数据均被弃去了，包括样品溶液稀释记录和天平称量打印纸。样品分析没有记录在仪器使用日志上。检验结果被从硬盘删除了，所有支持性色谱图均被废弃。审计追踪功能在2014年2月8日重新激活，然后重复了相同的样品检测。你们在2014年3月向FDA提交了2月8日的检测结果用以支持某原料药的DMF文件。 During the inspection, we asked the analyst who generated thedatasubmitted to the FDA whether audit trails could be disabled. Theanalyststated that another employee, who was no longer with the company, haddisabledthe audit trails. Your firm could not explain why the audit trailwasdisabled or why the original data was deleted, nor could youdemonstratewhether the original results were within specification. 在检查中，我们就审计追踪是否可以关闭的问题询问了实施检测获得FDA申报数据的化验员。化验员说是另一名化验员关闭的审计追踪功能，但该名化验员已经离开了公司。贵公司不能解释为什么审计追踪会被关闭，也不能解释为什么原始数据会被删除，更无法证明原始结果是否符合质量标准规定。 In your response, you assumed that the original raw data was deletedbecausea system suitability failure invalidated the data. You acknowledgedthatthe data should not have been invalidated without an investigation ofthelaboratory event. However, your response is inadequate. There is noevidenceto support invalidation of the original data on the grounds of asystemsuitability failure because your firm deleted all of the originalrecordsassociated with these analyses. 在你们的回复中，你们假定初始的原始数据是因为系统适用性失败导致结果无效才被删除的。你们承认不应该没有经过化验室事件调查即行宣布数据无效。你们的回复不够充分。没有证据支持你们关于“初始的原始数据是因为系统适用性失败导致结果无效才被删除的”的说法，因为贵公司已删除了那些样品分析的所有原始记录。 b. While reviewing the electronic log for HPLC system#28, we determinedthat two of your analysts deleted portions of HPLC samplesequence 20140221during assay, impurities, and identity testing for (b)(4)API batches (b)(4),and (b)(4). 在审核28#HPLC系统时，我们确定有两名化验员删除了HPLC样品序列20140221中的部分数据，这个序列是某原料药某批和某批的含量、杂质和鉴别测试。 During the inspection, the investigator reviewed the data package thatyourfirm used for batch release decisions for this drug. This datapackageincluded results from 44 HPLC injections. However, the electronicaudittrail from the instrument used to generate these results showed that therewerea total of 61 injections. Raw data for 17 of the 61 injections wasdeletedfrom the reported sequence as if the injections had never beenperformed.The investigator later discovered the missing data in a backupfolder. 在检查期间，我们的调查人员审核了贵公司用于该药品批放行决策的数据包。该数据包括了44针HPLC进样结果，但是，用以产生这些结果的仪器上的电子审计追踪显示总共有61针。这61针中的17针原始数据被从报告序列中删除了，就好像没有进过这17针样似的。调查人员后来在一个备份文件夹里发现了这些失踪的数据。 You stated in your response that these specific API batches “were soldto[the] Chinese market” and that you planned to retest batches (b)(4) todeterminewhether they are within specification. 你们在回复中声称这些特殊的原料药批号是“要销往中国市场的”，你们准备要对某批进行复测，以确定其是否符合质量标准。 You also stated in your response that the missing portions of thesamplesequence were actually injections conducted for training, so productqualitywas not affected by the deletions. This response is inadequate,because,regardless of the reason for conducting the injections, your laboratoryrecordsmust retain all original raw data. 你们在回复中还声称样品序列中那些失踪的部分实际上是为了培训进的针，因此产品质量不受数据删除的影响。此回复是不充分的，因为不管出于什么原因进了针，你们化验室都必须保留所有初始的原始数据。 c. While reviewing the audit trail on HPLC system #28, wedetermined thatone of your analysts performed trial HPLC injections duringassay and impuritiestesting for batches of (b)(4) API ((b)(4)and (b)(4)).These trial injections were performed on May 4-6,2014. The data for the sampleset was deleted from thesystem. Testing was not recorded in the instrument uselogbook. Allsupporting electronic raw data was discarded. Testing results forthesebatches were then recorded on May 7, 2014, when the analyses were repeatedusingHPLC system #32. 在审核28#HPLC审计追踪时，我们确定有一名化验室在某原料药某批和某批的含量和杂质测试中有试针。这些试针是在2014年5月4-6日进行。样品序列的数据被从系统中删除了。仪器使用日志中没有记录该检测。所有支持性电子原始数据均被弃去。这些批次的测试结果随后被记录在2014年5月7日，这天使用的是32#HPLC系统重复了该样品检测。 During our inspection, one of your analysts provided the originalanalysesworksheets to review. According to this analyst, tests were repeatedbecauseof poor column efficiency. The analyst neither initiated aninvestigation of thelaboratory event nor documented the original analyses inthe instrument uselogbook. The analyst did not respond when we asked whythe initial chromatogramswere deleted. 在我们的检查中，贵公司一名化验员提供了原始的检验记录供审核。根据此名化验员所述，重复测试是因为柱效太差。化验员没有启动化验室事件调查，也没有在仪器使用日志上记录原始检测信息。当我们质疑为什么会删除原始图谱时，这名化验员没有回答我们。 However, in your written response, you claimed that this analystlaterrecalled deleting the data (chromatogram) because column inefficiency mayhaveinvalidated the data. Your quality unit must review all pertinentanalyticaldata when making batch release decisions. When analysts deletenonconformingtest results, the quality unit is presented with incomplete andinaccurateinformation about the quality of the products. Your responsedoes notdemonstrate how your laboratory procedures prevent the deletion ofdata or howthe quality unit ensures that the records relied upon for batchrelease andother quality review decisions are complete and accurate. 在你们的书面回复中，你们声称该名化验员后来回想起删除这些数据（图谱）是因为柱效差，可能会使得数据无效。你们质量部门在做出批放行决策时，必须审核所有可能的分析数据。如果化验员删除了不符合的测试结果，质量部门看到的是不完整不准确的产品质量信息。你们的回复没有说明你们化验室程序如何防止数据删除，以及你们质量部门如何确保其赖以放行批产品和做出其它质量审核决策的记录是完整准确的。 Our concerns about deletion of data are heightened by thesignificantnumber of customer complaints for subpotency andout-of-specification (OOS)impurity levels from 2012-2014. We observed datadeletion in your laboratoryrelated to assay and impurity levels during thistime period. During theinspection, we asked to review your lab’s raw analyticaldata of the lotsassociated with four of the 61 complaints. However, you wereunable toprovide the raw data because it had been deleted. Without raw testdatafor the lots associated with these complaints, your firm could notadequatelyinvestigate the complaints, nor could you expand your investigationtodetermine whether other lots were affected by the same problems ortakecorrective actions, such as recalling drugs if appropriate. 在2012-2014年大量关于含量不够和杂质超标（OOS）的客户投诉中，我们对于数据删除的担心更加增强了。我们发现在此期间你们化验室在删除含量和杂质相关数据的现象。在检查中，我们要求查看你们化验室在61个投诉中的4个投诉中相关批次的原始分析数据，但是，你们无法提供这些原始数据，因为它们都已经被删除了。没有这些投诉相关批次的原始检测数据，贵公司无法对客诉进行充分调查，也无法扩展你们的调查来确定是否有其它批次受到相同问题的影响，也无法采取纠正措施，例如必要时的产品召回。 We acknowledge your commitment to hire a third-party consultant, setupuser access restrictions, and upgrade computerized systems with audittrails.However, simply activating audit trail functions and institutingpasswordcontrols are insufficient to correct the broad data manipulation anddeletionproblems observed at your facility and to prevent theirrecurrence. 我们已收到贵公司的承诺。你们承诺将会聘请第三方顾问，设定用户权限限制，升级至具有审计追踪功能的电脑系统。但是，仅仅是激活审计追踪功能，设置密码控制是不足以纠正在贵工厂发现的大量存在的数据做假和数据删除问题，防止其再次发生的。 Your management is responsible for the assuring that the scope andextentof the third party audit is adequate, including a full evaluationofsophisticated electronic systems and their potential formanipulation. Yourmanagement is also responsible for fully documentingand preserving records. 贵公司高层管理有责任确保第三方审计的范围和深度是充分的，包括对复杂电子系统和其做假可能性的全面评估。贵公司高级管理层还有责任保证全面的文件记录和记录保存。 For more information about handling OOS results and documentation ofyourinvestigations, please refer to Investigating Out-of-Specification(OOS)Test Results for Pharmaceutical Production at http://www.fda.gov/downloads/Drugs/.../Guidances/ucm070287.pdf and Questions and Answers on Current Good Manufacturing Practices,GoodGuidance Practices, Level 2 Guidance—Records and Reports at http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm124787.htm 关于OOS结果处理，以及贵公司调查的文件记录的更多信息，请参见“药品OOS结果调查指南”和CGMP问答，二级指南---记录和报告。 In your response to this letter, provide the following: 在贵公司对此函的回复中，应提供以下内容： l A comprehensive investigation and evaluation. Describe yourmethodology.Results should include conclusions about the extent of dataintegritydeficiencies and their root causes, which may involve recordcontrol,contemporaneous recording, deletion of data, and other dataintegritydeficiencies. l 一份全面的调查和评估。说明你们的方法。结果应包括数据完整性缺陷的广泛程度及其根本原因结论，这可能会涉及记录控制、同步记录、数据删除，以及其它数据完整性缺陷。 l A risk assessment of how the observed deficiencies may affectthereliability and completeness of quality information available for yourdrugs.Also determine the consequences of your deficient documentationpractices on thequality of drugs released for distribution. l 一份风险评估，评估所发现的缺陷对你们产品可获得质量信息的可靠性和完整性的可能影响。还要确定你们有缺陷的文件记录做法对已放行销售的药品的质量产生的后果。 l A management strategy that includes a detailed global corrective actionandpreventive action plan. l 一份管理策略，其中包括详细的全球纠正和预防措施计划。 Describe the actions you will take, such as contacting yourcustomers,recalling drugs, conducting additional testing and/or adding lots toyourstability programs, or other steps to assure the quality of yourdrugsmanufactured under the deficient conditions discussed above. 描述贵公司将要采取的行动，例如联系你们的客户、召回药品、实施附加测试和/或增加批次到你们的稳定性试验计划中，或其它措施来确保上述缺陷境况下你们生产的药品质量。 Describe the actions you will take, such as revisingprocedures,implementing new controls, training or re-training personnel, orother steps toprevent the recurrence of CGMP deviations, including breaches ofdataintegrity. 描述你们要采取的措施，例如修订程序、实施新的控制、人员培训或再培训，或其它措施来防止CGMP问题的再次发生，包括数据完整性问题。 2. Failure to conduct appropriate microbiological testingon API batcheswhere microbial quality is specified. 当原料药批次要求有微生物质量时，未能进行适当的微生物测试。 On March 2, 2015, we observed that all 14 culture media plates inincubator#6 were dried out and cracked, which compromised microbial growthpromotion andaccurate enumeration. These plates were used to test multiple APIbatchesof (b)(4) and (b)(4) and (b)(4)). 在2015年3月2日，我们发现在6#培养箱中的所有14个培养基碟已经干了并且都裂了，这种情况无法促进微生物生长及对其准确计数。这些碟子是用于测试多批原料药某批和某批。 Your investigation concluded that deformed glass plates caused the mediatocrack. In your response, you claimed that the issue was isolated to the14culture media plates and that you retested these (b)(4) batches. 你们的调查得出结论说玻璃碟变形导致培养基裂开。在你们的回复中，你们声明该问题和14个培养基碟不相干，然后你们复测了这些批次。 Your response is inadequate because your investigation did not evaluatethe(b)(4) other associated batches tested with culture media platesfromthe same lot containing deformed glass plates. In addition, we disagreewithyour claim that these dried culture media plates were isolated to the 14plateswe observed on March 2, 2015. On March 5, 2015, we observed twoadditionalculture media plates in incubator SPX-150, SeriesNo. 061103-811-0003, whichalso showed signs of drying out. 你们的回复是不充分的，因为你们的调查没有评估使用相同的变形玻璃碟进行测试的其它某相关批次。另外，我们不认同你们声明说这些干裂的培养基碟与我们在2015年3月2日发现的14只碟不相干。在2015年3月5日，我们发现在SPX-150，序号为No. 061103-811-0003的培养箱中有另外2只培养基碟，也显示出干掉的迹象。 From 2012 to 2014, several of your customers complained thatmicrobialresults were OOS when they tested your API upon receipt. In yourresponse,you concluded that the percentage of customer complaints reportingOOSmicrobial test results was insignificant. You attributed the customers’OOSmicrobial results to test methods that differ from your own. 从2012-2014年，你们的几个客户投诉说收到你们的原料药进行检测时发现微生物结果超标（OOS）。在你们的回复中，你们给出的结论是只有很少客户投诉微生物检测结果超标。你们将客户的微生物OOS结果归因于他们使用的检测方法与你们的方法有差异。 Your response lacks your findings and corrective actions from yourrecentinvestigation of dried out and cracked culture media plates. Forexample,you did not retest the batches that received OOS microbial complaints,even afterwe pointed out this deficiency. You lack scientific justificationtoconclude that your customers’ OOS findings are inaccurate or insignificant. 你们的回复中没有说明你们最近对干裂培养基碟调查后发现的情况和纠正措施。例如，你们没有复测所收到的OOS微生物投诉批次，甚至在我们指出该缺陷后也没有复测。你们缺乏科学的论证来支持你们所说的“你们客户的OOS发现是不准确的或无意义的”结论。 In your response to this letter, provide the following: 在贵公司对此函的回复中，请提供以下： l An accelerated timeline for completing retroactive microbial testing ofallpotentially-compromised batches via an independent laboratory, and acommitmentto respond with all results promptly. l 一份时间表，通过独立的化验室加快完成追溯所有潜在受影响批次的微生物测试，承诺将对所有结果立即做出回应。 l Your review of all microbial test methods to ensure they are suitablefortheir intended use. l 你们对所有微生物测试方法进行的审核，以确保这些方法均适合于其既定用途。 l A detailed update on whether your firm has implemented any furtherriskmitigations, such as purchasing prepared culture plates from qualifiedoutsidevendors. l 一份详细的更新，说明贵公司是否已实施任何进一步风险降低措施，例如，从经过确认的采购已制备好的培养基碟。 l Your improved deviation and corrective action and preventiveactionmanagement procedure. l 你们改进后的偏差和CAPA管理程序 l Documentation of all changes implemented as a result of your reviewandremediation of these issues. l 在你们审核并弥补了这些问题后，所有实施变更的文件记录， Access to information during inspection 检查期间获得资料的情况 We note that some records we requested during the inspection werenotprovided in a timely manner. 我们注意到，在检查期间我们索取了一些记录，你们不能及时提供。 During the inspection, an analyst removed a USB thumb drive from a computercontrollingan HPLC. When asked to provide the drive, the analyst insteadexited the roomwith the thumb drive. After approximately 15 minutes,management provided ourinvestigator with what they asserted was the USB thumbdrive in question. It isimpossible to know whether management providedthe same USB thumb drive that theanalyst had removed. 在检查期间，一名化验员从一台HPLC仪器控制电脑中拨出一个U盘。当我们要求提供这个U盘时，该化验员带着U盘离开了房间。在约15分钟之后，管理人员提供给我们调查人员一个U盘，他们说这就是当时被化验员带走的U盘。我们无法知道管理人员所提供的U盘是否正是该名化验员所拨出的U盘。 When an owner, operator, or agent delays, denies, limits, or refusesaninspection, the drugs may be adulterated under section 501(j) of theFD&CAct. We recommend that you review FDA’s guidance for industry CircumstancesthatConstitute Delaying, Denying, Limiting, or Refusing a Drug Inspection at: http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM360484.pdf 当企业主、操作员或代理延误、否定、限制或拒绝检查时，根据美国食品药品化妆品法案第501(j)部分规定，其药品将被作为假药处理。我们建议你们核对FDA行业指南“被认为是延误、否定、限制或拒绝药品检查的情形”。 Conclusion 结论 Deviations cited in this letter are not intended as an all-inclusive list.Although we acknowledge and appreciate your significant efforts toimplementcorrective actions to date, FDA will conduct a follow-up inspectionfollowingthe complete implementation of global corrective actions. 在本函中引用的偏差并无意成为完整的问题清单。尽管我们收到并感谢你们到今天为止为所实施的纠正措施付出的巨大努力，但FDA将在你们完成全球纠正措施实施后进行跟踪检查。 If, as a result of receiving this warning letter or for other reasons,youare considering a decision that could reduce the number of drugs producedbyyour manufacturing facility, FDA requests that you contact CDER'sDrugShortages Staff immediately, as you begin your internal discussions, at drugshortages@fda.hhs.gov so that we can work with you on the most effective way to bringyouroperations into compliance with the law. Contacting the Drug ShortagesStaffalso allows you to meet any obligations you may have to reportdiscontinuancesin the manufacture of your drug under 21 U.S.C. 356C(a)(1), andallows FDA toconsider, as soon as possible, what actions, if any, may beneeded to avoidshortages and protect the health of patients who depend on yourproducts. 如果因为收到本警告信或其它原因，贵公司考虑可能会决定减少贵生产场所药品生产量，FDA要求你们立即联系CDER药品短缺人员。当你们开始内部讨论时，请发邮件至上述邮箱，这样我们可以与你们一起以最有效的方式让你们回复符合法律要求的状态。联系药品短缺办公室也会让你履行所有可能义务，根据21 U.S.C. 356C(a)(1)要求报告药品生产中断情况，让FDA在可能时即行考虑需要采取何种措施（必要时）来避免短缺，保护依赖贵公司药品的患者健康。 Until you complete all corrections and FDA confirms your compliancewithCGMP, FDA may withhold approval of any new applications or supplementslistingyour firm as a drug manufacturer. 在贵公司完成所有纠正措施，FDA确认贵公司符合CGMP之前，FDA会暂停贵公司作为药品生产商所提交的所有新申报和增补申报。 Because of the findings of the FDA inspection described herein, yourfirmwas placed on Import Alert 66-40 on September 9, 2015. If you failtocorrect these deviations, FDA may continue to refuse admission ofarticlesmanufactured at Zhejiang Hisun Pharmaceutical Co., Ltd., 46 WaishaRoad,Jiaojiang District, Taizhou City, Zhejiang Province, under Section80l(a)(3) ofthe FD&C Act, 21 U.S.C. 38l(a)(3) as the manufacturing methodsand controlsdo not appear to conform to CGMP within the meaning of Section 501(a)(2)(B) ofthe FD&C Act, 21 U.S.C. 351 (a)(2)(B). 鉴于FDA检查期间发现的问题，已于2015年9月9日将贵公司置于66-40进口禁令清单中。如果贵公司未能纠正这些问题，FDA将会根据联邦食品药品和化妆品法案21 U.S.C. 38 (a)(3)第801(a)(3)部分条款，拒绝许可所有在Zhejiang Hisun Pharmaceutical Co., Ltd., 46Waisha Road, JiaojiangDistrict, Taizhou City, Zhejiang Province生产的产品，因为其生产方法和控制不符合联邦食品药品和化妆品法案21 U.S.C. 351(a)(2)(B)第501(a)(2)(B)部分CGMP要求。 Within 15 working days of receipt of this letter, please notifythisoffice, in writing, of the specific steps that you have taken to correctandprevent the recurrence of deviations detailed in this letter. 在收到此函15个工作日内，请书面通知以下办公室你们已采取的纠正和预防本函所列问题再次发生的详细措施。 If you cannot complete corrective actions within 15 working days,stateyour reasons for the delay and the date by which you will have completedthecorrections. If you no longer manufacture or distribute the drugs atissue,provide the date(s) and reason(s) you ceased production. Send yourreply to: 如果你不能在15个工作日内完成纠正措施，请说明延误的原因，以及完成纠正措施的预计日期。如果你不再生产或销售受影响药品，请提交停产日期和原因。回复请发至： （地址信息略） 蒲公英微信公众号“ouryaoinfo” 2016年共发布文章2345篇，总字数485万字，累计阅读近1100万人次，发布天数365天（全年共366天）。在蒲公英论坛各位蒲友的支持下，2016年蒲公英微信运营团队取得了优异的成绩，2017向各位蒲友继续征稿，欢迎关注！ 感谢上海凌致赞助发布并提供所有作者奖品。
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