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Warning Letter 320-16-22 ViaUPS Return Receipt Requested July 19, 2016 Mr. Zhang Jian Owner Xiamen Origin Biotech Co., Ltd. No. 7 Xiang Yue Road Xiamen Torch, Xiamen
Fujian 361101 CHINA Dear Mr. Zhang Jian: The U.S. Food and Drug Administration (FDA) inspectedyour drug manufacturing facilities Xiamen Origin Biotech Co., Ltd. (AttixXiamen Pharmaceutical Co., Ltd.) at Unit D504 Jian Ye Building, 96 XiangxingRoad and No. 7 Xiang Yue Road, Xiamen Torch, Xiamen, Fujian, from January18-20, 2016. DA于2016年1月18-20日对你工厂进行了检查。 This warning letter summarizes significant deviationsfrom current good manufacturing practice (C GMP) for active pharmaceuticalingredients (API). 此警告信中列出了原料药重大CGMP缺陷。 Because your methods, facilities, or controls formanufacturing, processing, packing, or holding do not conform to CGMP, your APIare adulterated within the meaning of section 501(a)(2)(B) of the Federal Food,Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 351(a)(2)(B). 由于你们生产、加工、包装或保存的方法、设施或控制不符合CGMP要求，你们的原料药被认为是掺假。 We have not received a response from your firm forcorrective actions to the deviations identified during the inspection. Weacknowledge your June 14, 2016, correspondence regarding placement of your firmon Import Alert 66-40. 我们尚未收到你公司在检查期间发现的缺陷的CAPA回复。我们已告知你们公司将你们公司列入进口禁令清单66-40。 Our investigator observed specific deviationsincluding, but not limited to, the following. 我们的调查人员在检查期间发现了一些特定的缺陷，包括但不仅限于以下： 1. Failure to establish, document,and implement an effective system for managing quality. 未能建立、记录和实施有效的质量管理体系 Your firm had no written procedures for supplier qualification,relabeling operations, sampling, product release, document retention, ortraining. Your firm was unable to provide our investigator records forrelabeling operations from before September 2014. 你公司没有书面的供应商确认、再标签操作、取样、产品放行、文件保存和培训程序。你的公司不能为我们调查员提供2014年9月前后的再标签操作记录。 2. Failure to transfer all qualityor regulatory information received from the API manufacturer to your customers. 未能将所有从原料药生产商处收到的质量和注册信息转给你的客户。 You repeatedly falsified and omitted information onthe certificates of analysis (CoA) you issued to your customers. For example,your firm fabricated the name of an employee, and you used that name as thefalse signatory authority on the CoA you sent to your customers. You alsoomitted the name and address of the original API manufacturer and did notinclude a copy of the original batch certificate. Finally, you included an“expiration date” on your CoA that exceeded the manufacturer’s labeledexpiration date, but you had no basis for the extended retest/expiryperiod. 你们一再伪造和删除你们签发给你们客户的COA上的信息。例如，你们公司虚构了一个员工的姓名，你们使用这个姓名伪造COA上的签名发给你们的客户。你们还删除了原始API生产商的名称和地址，没有包括原始批COA的复件。最后，你们在COA上放了一个“有效期”，这个有效期超过了生产商标示的有效期，但你们并没有依据来延长复验/有效期。 Regulators and customers rely on CoA to provideaccurate information regarding drug quality and pedigree. Omitting andfalsifying information on CoA compromises supply chain accountability andtraceability and may put consumers at risk. 法规管理人员和客户依赖于COA提供准确的药品质量和来源信息。删除和伪造COA上的信息让供应链可靠性和追溯性受到危害，可能会使得消费者处于风险之中。 3. Failure to keep buildings used inthe manufacture of API in a clean condition. 未能让原料药生产所用建筑处于洁净状态 During the inspection, the investigator recorded dirtywarehousing spaces and observed a rodent in the room adjacent to the warehouseat your facility. 在检查期间，调查员记录了脏的仓库空间，观察到你们工厂邻近仓库的房间里有虫鼠。 Access to information during inspection 在检查期间信息获得情况 During the inspection, your firm also made misleadingor deceptive statements and delayed the investigator’s access to accurate andtruthful information. For example: 在检查期间，你们公司还给出误导性和欺骗性声明，拖延调查员获得准确真实信息。例如： - During the inspection, an employee told the investigator that there were no drugs on site. The investigator observed a room adjacent to the conference room that was being used as a warehouse for relabeled drugs.
- 在检查期间，一个员工告诉调查员在工厂里没有药品。调查员在会议室旁边的房间被用作重新标签的药品的仓库。
- The same employee told the investigator that your firm stopped relabeling drugs in January, 2015. However, during the inspection, the investigator reviewed an exported drugs list that showed that your firm distributed drugs after January 2015 and into January 2016.
- 同一位员工告诉调查员，说你们公司已经于2015年1月停止重新标签药品，但是，在检查中，调查员审核了进口药品清单，清单显示你们公司在2015年1月到2016年1月期间仍在销售药品。
When an owner, operator, or agent delays, denies,limits, or refuses an inspection, the drugs may be adulterated under section501(j) of the FD&C Act.We recommend that you review FDA’s guidance forindustry Circumstances that Constitute Delaying, Denying, Limiting, orRefusing a Drug Inspection at: http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM360484.pdf 如果业主、操作工或代理拖延、否定、限制或拒绝检查，则药品会根据FDCA的第501（j）未被定为掺假药品。我们建议你们核对FDA行业指南“构成拖延、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 anall-inclusive list. You are responsible for investigating these deviations, fordetermining the causes, for preventing their recurrence, and for preventingother deviations in all your facilities. 在本函中引用的偏差并不是全部。你们有责任调查这些偏差，找出原因，防止其再次发生，防止你们工厂内其它偏差。 After you receive this letter, you have 15 workingdays to respond to this office in writing. Specify what you have done since ourinspection to correct your deviations and to prevent their recurrence. 在你们收到此函后，你们有15个工作日来做书面回复。说明自从我们的检查之后，你们做了什么来纠正你们的偏差，防止其再次发生。 Based upon the nature of the deviations we identifiedat your firm, we strongly recommend engaging a consultant qualified to evaluateyour operations and assist your firm in meeting CGMP requirements. Your use ofa consultant does not relieve your firm’s obligation to comply with CGMP. Yourfirm’s executive management remains responsible for fully resolving alldeficiencies and ensuring ongoing CGMP compliance. 根据我们在你们公司发现的偏差情况，我们强烈建议你们雇请有资格评估你们运行的顾问，协助你们公司符合CGMP要求。你们使用顾问并不能解除你们公司符合CGMP的义务。你们公司的执行管理人员仍负有解决所有缺陷，保证持续CGMP符合性的全部义务。 If you cannot complete corrective actions within 15working days, state your completion date and reasons for delay. 如果你们不能在15个工作日内完成所有纠正措施，请说明你们完成日期，以及延迟的理由。 Because of the findings of the FDA inspectiondescribed in this letter, your firm’s facilities were placed on Import Alert66-40 on May 13, 2016. 鉴于此函中FDA检查中发现的缺陷，你们公司工厂于2016年5月13日被列在进口禁令66-40清单中。 Until you completely correct all deviations and weconfirm your compliance with CGMP, FDA may withhold approval of any newapplications or supplements listing your firm as an API manufacturer. Failureto correct these deviations may also result in FDA continuing to refuseadmission of articles manufactured at Xiamen Origin Biotech Co., Ltd. (AttixXiamen Pharmaceutical Co., Ltd.) at Unit D504 Jian Ye Building, 96 XiangxingRoad and No. 7 Xiang Yue Road, Xiamen Torch, Xiamen, Fujian, into the UnitedStates under section 801(a)(3) of the FD&C Act, 21 U.S.C. 381(a)(3). Underthe same authority, articles may be subject to refusal of admission, in thatthe methods and controls used in their manufacture do not appear to conform toCGMP within the meaning of section 501(a)(2)(B) of the FD&C Act, 21 U.S.C.351(a)(2)(B). Send your reply to: Lynnsey Renn, Ph.D. Compliance Officer U.S. Food and Drug Administration White Oak Building 51, Room 4359 10903 New Hampshire Avenue Silver Spring, MD 20993 USA Please identify your response with FEI 3010307355. Sincerely, /S/ Francis Godwin Acting Director Office of Manufacturing Quality Office of Compliance Center for Drug Evaluation and Research
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发表于 2016-8-7 13:11:06
置顶卡
变色卡
发表于 2016-8-7 15:30:09
学习了，谢谢分享！
我靠，这样的企业也有勇气接受FDA的现场检查！
