The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Foshan Flying Medical Products Co., Ltd. at Zumiao 1st Road, Chancheng, Xiaofengtian Industrial District, Wuzhuang, Luocun Town, Foshan City, Guangdong Province from February 20–23, 2017.
FDA于2017年2月20-23日检查了你们位于佛山禅城丰田工业区祖庙一路的佛山福莱茵药品有限公司。
This warning letter summarizes significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. See 21 CFR, parts 210 and 211.
本警告信总结了成品违反CGMP法规的重大偏差。
Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your drug products are 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).
因为你们的方法、设施、或生产、加工、包装、或保存的控制不符合CGMP，你们的药品被认定为掺假。
We reviewed your March 29, 2017, response in detail, and acknowledge receipt of your subsequent response.
我们审阅了你们于2017年3月29日及之后的回复。
During our inspection, our investigator observed specific violations including, but not limited to, the following.
在我们检查期间，我们的检查员发现的具体违规包括但不限于，如下：
1. Your firm failed to establish an adequate quality control unit and procedures applicable to the quality control unit with the responsibility and authority to approve or reject all components, drug product containers, closures, in-process materials, packaging materials, labeling, and drug products (21 CFR 211.22(a) and (d)).
未能建立充分的质量控制部门以及适用于质量控制部门行使其批准和拒绝所有成分、药品容器、密封部件、中间物料、包装材料、标签和药物成品的责任和权力的规程。
Your firm lacks an adequate quality control unit.
贵司没有一个充分的质量控制部门。
You failed to establish written procedures for numerous functions. For example, there were no procedures addressing the quality control unit, complaints, deviations, investigations, and various other basic drug manufacturing operations.
你们未能建立各个职能的书面规程。例如，对质量控制部门、投诉、偏差、调查和各种其他基本药品生产操作并没有规程。
Further, your quality unit lacked documentation to demonstrate acceptability of batch manufacturing and quality. For instance, you lacked records relating to:
而且，你们的质量部门没有文件证实批生产及其质量的可接受性。例如，你们没有关于如下方面的记录：
· change control;
· 变更控制
· annual product reviews;
· 年度产品回顾
· batch record review to assure that any errors were fully investigated; and
· 批记录审核以确保任何错误均得到充分的调查，并且
· approval or rejection of your drug products.
· 药物成品的批准或拒绝
In addition, for the past three years, your quality unit consisted of (b)(4) employee from the production department, whose responsibilities included recording information in batch records during operations.
另外，在过去的3年里，你们的质量部门由来自生产部门的XX雇员组成，其职责还包括了生产过程中在批记录中记录信息。
2. Your firm failed to perform, for each batch of drug product, appropriate laboratory determination of satisfactory conformance to final specifications for the drug product, including the identity and strength of each active ingredient, prior to release, and conduct appropriate laboratory testing for each batch of drug product required to be free of objectionable microorganisms (21 CFR 211.165(a) and (b)).
在放行之前，贵司未能对药品进行适当的实验室检验其符合最终标准，包括每个活性成的鉴定和含量，也未能对要求没有致病微生物的每批药品的进行适当的实验室检验。
You released finished drug products without adequate acceptance testing. For example, you did not test your (b)(4) and (b)(4) to determine if they conformed to the identity or strength stated on the label. In addition, you did not adequately test for critical microbial attributes (e.g., absence of objectionable microorganisms, total count).
你们放行了成品而没有充分的可接受性检验。例如，你们没有检验你们的XX和XX以确定是否符合标签所述鉴定和含量。另外，你们没有充分检验关键微生物属性（例如，不含致病菌、总微生物限度）
3. Your firm failed to have, for each batch of drug product purporting to be sterile and/or pyrogen-free, appropriate laboratory determination of satisfactory conformance to final specifications for the drug product (21 CFR 211.167(a)).
对每批要求无菌和/或无热原的药品，贵司没有适当的实验室检验其符合药品最终标准。
You market an (b)(4) product labeled as “sterile.” The label states that the product is used “(b)(4).” However, you failed to perform sterility testing. It is essential that you conduct sterility testing on these and other purportedly sterile drugs prior to batch disposition decisions.
你们销售一种XX产品，标明无菌。该标签所该产品用起来“XX”。然而，你们未能进行无菌检验，你们有必要在批放行对其进行无菌检验。
4. Your firm failed to establish written procedures for production and process control designed to assure that the drug products you manufacture have the identity, strength, quality, and purity they purport or are represented to possess (21 CFR 211.100(a)).
对于生产和工艺控制，贵司未能建立书面规程用以确保所生产的药品拥有其应有鉴定、含量、质量和纯度。
Your firm lacks an ongoing program for monitoring process control to ensure stable manufacturing operations and consistent drug quality. See FDA’s guidance document, Process Validation: General Principles and Practices, for approaches that FDA considers appropriate elements of process validation, at http://www.fda.gov/downloads/Drugs/.../Guidances/UCM070336.pdf
贵司缺乏一个持续的程序监测工艺控制以确保稳定的生产操作和一直的产品质量，FDA关于工艺验证的要素参见FDA的指南文件《工艺验证：一般原则与规范》。
In response to this letter, detail your validation plan for ensuring an ongoing state of control. Include a timeline for performing process performance qualification (PPQ) for each of your drug products, and describe your approach for monitoring batch-to-batch variation on an ongoing basis.
回复此函，详细描述你们确保持续受控状态的验证计划。包括对每一个药品实施工艺性能确认的时间表，以及描述你们持续监测批间变化的方法。
