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Warning Letter: 320-16-20 警告信 翻译人：赵双春、林茹、杨耀智 沈阳同联集团有限公司 质量部 ViaUPS Return Receipt Requested 经由UPS 回执要求 June 22, 2016 2016年6月22日 Mr. Shihai Zou General Manager Guangzhou Haishi Biological Technology Co.,Ltd. 1/F, 2/F, Bldg.1, No.3, Songyuan Rd. New Industrial Zone, No.11 She, Xiamao Guangzhou, Guangdong 510450 China 邹世海先生 总经理 广州海世生物科技有限公司 1/F, 2/F, Bldg.1, No.3, Songyuan Rd. New Industrial Zone, No.11 She, Xiamao 广州，广东510450 中国 Dear Mr. Zou: The U.S. Food and Drug Administration (FDA)inspected your drug manufacturing facility, Guangzhou Haishi BiologicalTechnology Co., Ltd. at 1/F, 2/F, Bldg. 1, No. 3, Songyuan Road, New IndustrialZone, No. 11 She, Xiamao, Guangzhou, Guangdong, from July 20-24, 2015. FDA于2015年7月20-24日检查了你们的制药厂，广州海世生物科技有限公司。这个制药厂位于广东省广州市夏茅十一社新工业区松圆路3号建筑物1座第1、2层。 This warning letter summarizes significantviolations of current good manufacturing practice (C GMP) regulations forfinished pharmaceuticals. See 21 CFR, parts 210 and 211. 该警告信总结了显著违反药品现行良好生产规范（cGMP）的规定。见21CFR，210和211部分。 Because your methods, facilities, orcontrols for manufacturing, processing, packing, or holding do not conform toCGMP, your drug products are adulterated within the meaning of section501(a)(2)(B) of the Federal Food, Drug, and Cosmetic (FD&C) Act, 21 U.S.C.351(a)(2)(B). 由于你们的研究方法，设施，或用于制造，加工，包装，持有控制不符合cGMP，你们的成品药根据联邦食品、药品及化妆品法案第501（A）（2）（B），21USC 351（A）（2）（B），被作为掺假。 We reviewed your firm’s August 14, 2015,response in detail and acknowledge receipt of your subsequent response. 我们审核了你们公司于2015年8月14日递交的详细回复，并且我们也收到了你们的后续回复。 Our investigators observed specificviolations including, but not limited to, the following. 1. Your firm failedto test finished batches of your drug products for the identity and strength ofactive ingredients (21 CFR 211.165(a)). 2. Your firm failedto conduct at least one specific identity test on a component when relying onthat component supplier’s analysis (21 CFR 211.84(d)(2)). 3. Your firm failedto establish adequate written procedures for production and process controldesigned to assure that the drug products you manufacture have the identity,strength, quality, and purity they purport or are represented to possess (21CFR 211.100(a)). 我们的检查人员观察到的具体违规行为，包括但不限于以下内容。 1、 你们公司未能完成生产成品批次所用的药物活性成分鉴别和强度的测试 (21 CFR 211.165(a))。 2、 你们公司信任供应商的检测结果，而未能进行至少一项特征鉴别检验(21 CFR 211.84(d)(2))。 3、 你们公司未建立充分的书面生产程序和过程控制系统，以确保你们生产的成品药所应具备的鉴别、强度、质量和纯度等特质。（21CFR211.100（A））。 Despite these violations and others citedon the July 24, 2015, Form FDA 483, your quality unit released multiple batchesof drug products for distribution. 尽管存在这些违规行为以及2015年7月24日FDA483表格中的其他事项，你们公司质量部依旧将多批次的药品予以放行流通。 In your firm’s response of August 14, 2015,you state that you will purchase analytical instruments and standards toconduct incoming material testing and finished product testing. However,your response is inadequate as you did not commit to testing every batch offinished product prior to release. Furthermore, you did not include a riskassessment for all your drug products within expiry that have been distributedto the United States. 你们公司2015年8月14日的回复中提到，你们将购买分析仪器和标准品来进行原料检验和成品检测。然而，贵公司回复不够充分，因为你们在放行前未提供发布的每一批成品的检测报告，此外，你们公司未对已流通到美国的效期内产品进行风险评估 Based upon the nature of the violations weidentified at your firm, we strongly recommend engaging a consultant, qualifiedas set forth in 21 CFR 211.34, to assist your firm in meeting CGMPrequirements. Your use of a consultant does not relieve your firm’s obligationto comply with CGMP. Your firm’s executive management remains responsiblefor fully resolving all deficiencies and ensuring ongoing CGMP compliance. 基于我们已确认的你们公司的违法行为，我们强烈建议聘请顾问，协助你们公司实现21CFR 211.34以符合cGMP要求。，你们使用的顾问并不代表你们可以免除自身实现cGMP责任。你们公司的高级管理层应继续负责全面解决所有的缺陷，并确保符合cGMP标准。 Conclusion 结论 Violations cited in this letter are notintended as an all-inclusive list. You are responsible for investigating theseviolations, for determining the causes, for preventing their recurrence, andfor preventing other violations. 这封信中举出的违规行为不作一个详尽的列表。你们公司有责任调查这些违规行为，确定原因，以防止再次发生，并防止其他违规行为。 After you receive this letter, you have 15working days to respond to this office in writing. Specify what you have donesince our inspection to correct your violations and to prevent theirrecurrence. 收到这封信后，15个工作日内书面回应。对我们检查出的违规纠偏行为做一个详细的说明，防止其复发。 If you cannot complete corrective actionswithin 15 working days, state your completion date and reasons for delay. 如果不能在15个工作日完成纠正措施，陈述完成日期和延迟原因。 Because of the findings of the FDAinspection described in this letter, your firm was placed on Import Alert 66-40on March 14, 2016. 因为在这封信中描述了FDA检查的结果，你们公司于2016年3月14日被置于FDA进口禁令中。 Until you completely correct all violationsand we confirm your compliance with CGMP, FDA may withhold approval of any newapplications or supplements listing your firm as a drug product manufacturer.Failure to correct these violations may also result in FDA continuing to refuseadmission of articles manufactured at Guangzhou Haishi Biological TechnologyCo., Ltd. located at 1/F, 2/F, Bldg. 1 No. 3, Songyuan Road, New IndustrialZone, No. 11 She, Xiamao, Guangzhou, Guangdong, into the United States undersection 801(a)(3) of the FD&C Act, 21 U.S.C. 381(a)(3). Under the sameauthority, articles may be subject to refusal of admission, in that the methodsand controls used in their manufacture do not appear to conform to CGMP withinthe meaning of section 501(a)(2)(B) of the FD&C Act, 21 U.S.C.351(a)(2)(B). 直到你们彻底处理完所有的违规行为，并且我们确认你们公司符合cGMP的要求，FDA才可能批准新的申请或补充批准你们公司作为产品制造商。未能正确处理这些违规行为也可能导致FDA基于美国的801条（a）（3）21 U.S.C.381(a)(3)而继续拒绝广州海世生物科技有限公司制造的产品（公司位于广东省广州市夏茅十一社新工业区松原路3号建筑物1座第1、2层。）。到，。在同样的情况下，由于在生产过程中使用的方法和控制不符合cGMP的501节中的意义（a）（2）（b）的FD&C法案，21U.S.C. 351（a）（2）（b），仍可能被拒绝。 Send your reply to: Runa Musib, Ph.D. Interdisciplinary Scientist U.S. Food and Drug Administration White Oak Building 51, Room 4359 10903 New Hampshire Avenue Silver Spring, MD 20993 USA 发送你的回复至： RunaMusib博士 跨领域的科学家 美国FDA 白橡木建筑51号,4359室 新汉普郡大街10903号 银泉，MD20993 美国
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发表于 2016-7-7 13:10:30
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