本次警告信发给的企业为:湖州欧宝卫生用品有限公司。涉及的缺陷如下:
1、每批药品在放行前没有适当的化验室检测,确定其符合药品最终质量标准,包括每种活性成分的鉴别和含量(21 CFR 211.165(a))。
2、未能建立和遵循用于评价药品稳定性的书面试验程序。此试验用于测定合适的贮存条件和有效期。
3、未能建立充分的生产和工艺控制的书面程序来确保药品有其所声称的鉴别、含量、质量及纯度。
4、未能建立和遵循用于生产、加工、保证和储存药品的设备的清洁和维护的书面规程。
5、每一批的生产和控制,贵公司的批生产记录和批控制记录没有包含完整信息。
该警告信中表示,并未收到该公司的整改回复,于是发了警告信。
 这封警告信的正文如下:
Via UPSWarning Letter 320-16-25Return Receipt RequestedAugust 10, 2016Mr. Xinhua WangOwner & General ManagerHuzhou Aupower Sanitary Commodity Co., Ltd.湖州欧宝卫生用品有限公司Jingsan Road, Changxing Economic & Technical Development DistrictHuzhou City, Zhejiang, 313100China
Dear Mr. Wang:The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Huzhou Aupower Sanitary Commodity Co., Ltd., Jingsan Road, Changxing Economic & Technical Development District, Huzhou City, Zhejiang, from September 14–18, 2015.美国FDA与2015九月14日~18日检查了你的药物生产工厂,湖州欧宝卫生用品有限公司,位于浙江湖州市长兴经济技术开发区经三路。This warning letter summarizes significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. See 21 CFR, parts 210 and 211.本警告信概述了现行药品GMP条款的重大违规,见21 CFR, 210 和211部分。
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).由于你们的方法、设施,或生产、加工、包装或保存的控制不符合CGMP,你们的药品根据21 U.S.C联邦食品、药品、化妆品法(FD&C Act) 501(a)(2)(B)章节认定为掺假。
We have not received a response from your firm for corrective actions to the violations identified during the inspection.我们还没有收到你们公司对检查期间发现的违规的整改回复。
Our investigator observed specific violations including, but not limited to, the following.我们的检察官观察到具体违规包括但不限于如下:1.Your firm does not have, 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 (21 CFR 211.165(a)).每批药品在放行前没有适当的化验室检测,确定其符合药品最终质量标准,包括每种活性成分的鉴别和含量(21 CFR 211.165(a))。
2.Your firm failed to establish and follow an adequate written testing program designed to assess the stability characteristics of drug products and to use results of such stability testing to determine appropriate storage conditions and expiration dates (21 CFR 211.166(a)).贵公司未能建立和遵循用于评价药品稳定性的书面试验程序。此试验用于测定合适的贮存条件和有效期。
3.Your firm failed to establish adequate 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)).贵公司未能建立充分的生产和工艺控制的书面程序来确保贵公司的药品有其所声称的鉴别、含量、质量及纯度。
4.Your firm failed to establish and follow adequate written procedures for cleaning and maintenance of equipment (21 CFR 211.67(b)).贵公司未能建立和遵循用于生产、加工、保证和储存药品的设备的清洁和维护的书面规程。
5.Your firm failed to prepare batch production and control records with complete information relating to the production and control of each batch of drug product produced (21 CFR 211.188).每一批的生产和控制,贵公司的批生产记录和批控制记录没有包含完整信息。
Conclusion结论
Violations cited in this letter are not intended as an all-inclusive list. You are responsible for investigating these violations, for determining the causes, for preventing their recurrence, and for preventing other violations in all your facilities.After you receive this letter, you have 15 working days to respond to this office in writing. Specify what you have done since our inspection to correct your violations and to prevent their recurrence.
Based upon the nature of the violations we identified at your firm, we strongly recommend engaging a consultant, qualified as set forth in 21 CFR 211.34, to assist your firm in meeting CGMP requirements. Your use of a consultant does not relieve your firm’s obligation to comply with CGMP. Your firm’s executive management remains responsible for fully resolving all deficiencies and for ensuring ongoing CGMP compliance.
If you cannot complete corrective actions within 15 working days, state your completion date and reasons for delay.Because of the findings of the FDA inspection described in this letter, your firm was placed on Import Alert 66-40 on August 5, 2016.Until you completely correct all violations and we confirm your compliance with CGMP, FDA may withhold approval of any new applications or supplements listing your firm as a drug product manufacturer. Failure to correct these violations may also result in FDA continuing to refuse admission of articles manufactured at Huzhou Aupower Sanitary Commodity Co., Ltd., Jingsan Road, Changxing Economic & Technical Development District, Huzhou City, Zhejiang, 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 of admission, in that the methods and controls used in their manufacture do not appear to conform to CGMP within the meaning of section 501(a)(2)(B) of the FD&C Act, 21 U.S.C. 351(a)(2)(B).