FDA警告信 天津康森（节译）

Warning Letter: 320-16-23

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Return Receipt Requested

July 26, 2016

Mr. John Zhao

General Manager

Concept Products Limited

No. 33, The Third Branch Saida Road

Xiqing Economic Development Area

Tianjin, 300385

China

Dear Mr. Zhao:

The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Concept Products Limited, No. 33, The Third Branch Saida Road, Xiqing Economic Development Area, Tianjin, from August 3-5, 2015.

FDA于2015年8月3-5日对你工厂进行了检查。

This warning letter reviews significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. See 21 CFR, parts 210 and 211.

  此警告信中列出了药品重大CGMP缺陷。参见21CFR，第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).

由于你们生产、加工、包装或保存药品的方法、设施或控制不符合CGMP要求，你们的药品被认为是掺假。

We have reviewed your August 20, 2015, response in detail.  

我们详细审核了你们于2015年8月20日的回复。

Our investigator observed specific CGMP violations including, but not limited to, the following.

  我们的调查人员在检查期间发现了一些具体的缺陷，包括但不仅限于以下：

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)).

你公司对各批次药品放行之前没有进行适当的化验室检验，确定药品符合最终质量标准，包括每种活性成分的鉴别和剂量(21 CFR 211.165(a))。

2.    Your firm failed to withhold from use each lot of components, drug product containers, and closures until the lot had been sampled, tested, or examined, as appropriate, and released for use by the quality control unit (21 CFR 211.84(a)).

你们公司在使用各批组分、药品容器和密闭器之前，没有经过取样、检测或检查，并经过适当的质量部门放行(21 CFR 211.84(a))。

3.    Your firm failed to establish and follow a 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)).

你们公司未建立和遵守书面的检验程序，用以评估药品的稳定性，并使用此类稳定性检测结果来决定适当的存贮条件和有效期(21 CFR 211.166(a))。

4.    Your firm failed to establish written procedures for production and process controls, including validation protocols and reports, designed to assure that your firm’s drug products have the identity, strength, quality, and purity they purport or are represented to possess (21 CFR 211.100(a)).

你们公司没有建立书面生产程序和工艺控制程序，包括验证方案和报告，用以保证你们公司的药品具有其理应具备或声称具备的剂量、质量和纯度(21 CFR 211.100(a))。

5.    Your firm failed to establish and follow written procedures for cleaning and maintenance of equipment used in the manufacturing, processing, packaging or holding of a drug product (21 CFR 211.67(b)).

你们公司未能为生产、加工、包装或存贮药品的设备建立和遵守书面的清洁和维护程序(21 CFR 211.67(b))。

In your response of August 5, 2015, you acknowledged the significance of the CGMP observations and said you “(b)(4).” You did not commit to any corrective actions regarding the CGMP violations observed on the inspection.

你们在2015年8月5日的回复中说，你们知道CGMP缺陷的严重性，并且说“你们不承诺对检查中发现的CGMP违规情况采取任何的纠正措施”。

Conclusion

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 your facility.

If your firm resumes manufacturing drugs for the United States market, we strongly recommend engaging a consultant, qualified as set forth in 21 CFR 211.34, to assist your firm in meeting CGMP requirements. Using a consultant does not relieve your firm’s obligation to comply with CGMP. Notify this office, in writing, of the specific steps that you have taken to correct violations and prevent recurrence. Provide supporting documentation. If your firm cannot complete corrective actions, state the reasons and the date by which your firm will have completed the corrections.

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 refusing admission of articles manufactured at Concept Product Limited No. 33, the Third Branch Saida Road, Xiqing Economic Development Area, Tianjin, 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).

Send your reply to:

           

Loan Chin      

Pharmacist

U.S. Food and Drug Administration

White Oak Building 51, Room 4359

10903 New Hampshire Avenue

Silver Spring, MD 20993

USA

Send your electronic reply to CDER-OC-OMQ-Communications@fda.hhs.gov.

Please identify your response with FEI 3006594435.

Sincerely,

/S/

Francis Godwin

Acting Director

Office of Manufacturing Quality

Office of Compliance

Center for Drug Evaluation and Research

来源：http://zhuyujiao1972.blog.163.com/blog/static/98694727201671104418841/