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Warning Letter 320-16-34 ViaUPS Return Receipt Requested September 26, 2016 Mr. Yan Qunfeng General Manager Yangzhou Hengyuan Daily Chemical Plastic Co., Ltd. No. 1 Sitong Road Hanji Industrial Park Yangzhou, Jiangsu 225111 China Dear Mr. Yan: The U.S. Food and Drug Administration (FDA) inspected your drugmanufacturing facility, Yangzhou Hengyuan Daily Chemical Plastic Co., Ltd., atNo. 1 Sitong Road, Hanji Industrial Park, Yangzhou, Jiangsu, from January 18 to22, 2016. 美国FDA于2016年1月18-22日检查了你们工厂。 This warning letter summarizes significant violations of current goodmanufacturing practice (C GMP) regulations for finished pharmaceuticals. See 21CFR, parts 210 and 211. 此警告信总结了你们制剂生产违反CGMP情况。参见21CFR第210和211章。 Because your methods, facilities, or controls for manufacturing,processing, packing, or holding do not conform to CGMP, your drug products areadulterated 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、处理、包装和存贮方法、设施或控制不符合CGMP要求，你们的药品被判定为掺假药。 We reviewed your firm’s January 30, 2016, response in detail. 我们详细审核了你们于2016年1月30日发来的回复。 During our inspection, our investigator observed specific violationsincluding, but not limited to, the following. 在我们检查期间，我们的调查人员发现的具体违规情况包括但不仅限于以下： 1. Your firm failed to provide adequate writtenproduction and control procedures which are designed to assure that the drugproducts produced have the identity, strength, quality and purity they purportor are represented to possess (21 CFR 211.101). 贵公司未能提供足够的书面生产和控制程序以确保所生产的药品具备其理当具备的鉴别、剂量、质量和纯度。(21 CFR 211.101) FDA collected samples of your (b)(4) batch #(b)(4) at theport of entry. FDA Laboratory analysis found that your (b)(4) did notcontain any of the labeled active ingredient, (b)(4). FDA denied entryof the shipment accordingly and notified your customer, (b)(4), whichfiled a complaint with you. FDA在进口口岸收集了你们工厂某批号的样品。FDA化验室进行了分析并发现你们某产品不含有任何所标示的活性成分XX。FDA因而拒绝了你们产品进入美国，并通知了你们客户XX，他们启动了对你们的投诉。 Your subsequent investigation into the customer complaint for batch #(b)(4)revealed that, during (b)(4) of components, you added the wrongingredient, (b)(4), instead of the active ingredient. 你们之后对客户投诉进行的调查显示在XX组分中，你们加入了错误的成分YY而不是理应加入的活性成分。 2. Yourfirm does not have, for each batch of drug product, appropriate laboratorydetermination of satisfactory conformance to final specifications for the drugproduct, including the identity and strength of each active ingredient, priorto release (21 CFR 211.165(a)). 贵公司没有在放行前对所有批次药品进行适当的化验检测确定其满足最终制剂标准，包括每种活性成分的鉴别和剂量。(21 CFR 211.165(a)) During the inspection, you acknowledged that your firm did not test allbatches of finished drug product prior to release. For example, in 2015 youtested only five of the (b)(4) batches shipped to the United States. Wenote you did not perform the active ingredient assay for batch #(b)(4)prior to release. FDA analysis showed this batch contained no activeingredient. 在检查期间，你们说你们公司在放行药品之前并未对所有批次进行检测。例如，在2015年你们只检测了5批发到美国的XX。我们注意到你们在放行前并未检测批的活性成分含量。FDA分析显示该批次不含有活性成分。 Your quality unit must review all production and control records, andensure testing and conformance to all product specifications, prior topermitting release of a batch to the United States market. We acknowledge thatyou committed to test drug product batches for U.S. distribution in thefuture. 你们的质量部门必须审核所有生产和检测记录，确保进行了检测并符合所有产品质量标准，然后才可放行批次至美国市场。你们承诺在未来会检测所有销往美国的药品批次。 Your investigation indicated the warehouse released the wrong activeingredient for batch #(b)(4). This was the first of multiple errors thatled to adding the wrong ingredient to your drug product. 你们的调查显示仓库为某批次发放了错误的活性成分。这是多个错误的第一个，导致你们的药品中加入了错误的成分。 In response to this letter, provide an action plan to comprehensivelyevaluate your manufacturing operation to determine the root causes for theseerrors, and to prevent use of the wrong ingredient or other hazardous mix-upsfor all of your drug products. Additionally, provide the revised master batchrecord for (b)(4). Describe all improvements to batch records, includingaddition of verifications for all critical manufacturing steps. 在回复此函时，请提供一份行为计划，综合评估你们的生产操作，以确定这些错误的根本原因，防止使用错误的成分或所有药品的其它有害混淆。另外，请提供修订后的某产品母版批生产记录。描述所有批记录的改进，包括为关键生产步骤增加复核。 Describe your corrective actions and preventive actions (CAPA) to ensurethat your finished drug products meet their specifications. Evaluate previousbatches distributed in the United States within expiry to determine if theymeet specification. As part of your CAPA plan, describe how your quality unitauthorities and responsibilities will be enhanced to ensure ongoing oversightover your drug manufacturing operations. Also describe how you plan to measurethe effectiveness of your CAPA and a timeline for completion of these actions. 描述你们的CAPA，确保你们的制剂产品符合其质量标准。评估之前销往美国还在有效期内的批次，确定其是否符合质量标准。作为你们CAPA计划的一部分，描述你们质量部门的权力和职责。还要说明你们计划要如何衡量你们CAPA的有效性，以及这些措施的完整时间期限。 CGMP consultant recommended Based on the nature of the violations we identified at your firm, westrongly recommend engaging a consultant, qualified as set forth in 21 CFR211.34, to assist your firm in meeting CGMP requirements. Your use of aconsultant does not relieve your obligation to comply with CGMP. Your executivemanagement remains responsible for fully resolving all deficiencies andensuring ongoing CGMP compliance. Conclusion Violations cited in this letter are not intended as an all-inclusive list.You are responsible for investigating these violations, for determining thecauses, for preventing their recurrence, and for preventing other violations inyour facility. FDA placed your firm on Import Alert 66-40 on August 12, 2016. Until you correct all violations completely and we confirm your compliancewith CGMP, FDA may withhold approval of any new applications or supplementslisting your firm as a drug manufacturer. Failure to correct these violations may also result in FDA continuing torefuse admission of articles manufactured at Yangzhou Hengyuan Daily ChemicalPlastic Co., Ltd., No. 1 Sitong Road, Hanji Industrial Park, Yangzhou, Jiangsu,into the United States under section 801(a)(3) of the FD&C Act, 21 U.S.C.381(a)(3). Under the same authority, articles may be subject to refusal ofadmission, in that the methods and controls used in their manufacture do notappear to conform to CGMP within the meaning of section 501(a)(2)(B) of theFD&C Act, 21 U.S.C. 351(a)(2)(B). After you receive this letter, respond to this office in writing within 15working days. Specify what you have done since our inspection to correctyour violations and to prevent their recurrence. If you cannot completecorrective actions within 15 working days, state your reasons for delay andyour schedule for completion. Runa Musib, 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 3008519597. 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 2016-10-12 15:56:19
置顶卡
变色卡
发表于 2016-10-12 15:59:53
江苏呆了这么久，还真没听说过这家企业生产药品
针对每一封警告信，我们都要进行辩证分析，并选择性吸收转化~