瑞士Laboratoire Sintyl S.A. FDA警告信

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2016年6月20日至23日，FDA对瑞士Laboratoire Sintyl S.A.进行了检查，检查缺陷情况如下：

1. 你们没有建立适用于质量控制部门的书面的职责和程序，包括OOS结果和客户投诉的审核。在检查期间，你们显示了你们没有独立的质量部门。

2. 你们未能检测你们最终药品的活性成分的鉴别和含量。

3.你们未能确保鉴别来自不同供应商的成分，包括XX活性成分。

4.你们未能在适当的时间间隔内清洁和维护你们的XX设备以避免故障或污染你们的产品。在检查期间，我们发现在你们XX设备上有和锈一样的红褐色的变色。

5.你们没有为生产和工艺控制建立书面的程序，包括验证方案和报告，设计用来确保你们药品有它们声称或代表拥有的鉴别、含量、质量和纯度。在检查期间，你们承认你们公司没有工艺验证的程序。

6.你们没有数据证明你们产品的化学和物料属性在他们货架生命周期内能够保持可接受。

警告信原文如下：

                                                               

Warning Letter 320-16-37

Via UPS  

Return Receipt Requested

September 29, 2016

           

Mr. Rémy Pfenniger  

CEO/Owner

Laboratoire Sintyl S.A.

Route Des Jeunes 23

Carouge Ge, Geneva, 1227

Switzerland

Dear Mr. Rémy Pfenniger:

The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Laboratoire Sintyl S.A. at Route Des Jeunes 23, Carouge Ge, Geneva, from June 20 to 23, 2016.

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

Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your drug product is 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).

We reviewed your July 5, 2016, response in detail. In that response, you stated that you produced (b)(4) over-the-counter drug and have ceased its manufacture. You did not commit to (b)(4) and to keeping FDA informed of the (b)(4) progress. You have yet to provide FDA with any evidence to document that a (b)(4) has occurred.

During our inspection, our investigator observed specific violations including, but not limited to, the following.

1.    You failed to establish written responsibilities and procedures applicable to the quality control unit, including the review of out-of-specification results and customer complaints. (21 CFR 211.22(d)). During the inspection, you indicated that you have no independent quality unit.

2.    You failed to test finished batches of your drug products for the identity and strength of active ingredients. (21 CFR 211.165(a))

3.    You failed to ensure the identity of components sourced from various suppliers, including your (b)(4) active ingredients. (21 CFR 211.84(d)(1) and (2))

4.    You failed to clean and maintain your (b)(4) at appropriate intervals to prevent malfunctions or contamination of your drug products. (21 CFR 211.67(d)). During the inspection, we observed reddish brown discoloration consistent with rust on your (b)(4).

5.    You failed to establish written procedures for production and process controls, including validation protocols and reports, designed to assure that your drug products have the identity, strength, quality, and purity they purport or are represented to possess. (21 CFR 211.100(a)). During the inspection, you acknowledged that your firm has no procedures for process validation.

6.    You have no data to demonstrate that the chemical and physical properties of your products remain acceptable throughout their shelf lives. (21 CFR 211.166(a))

You distributed at least (b)(4) batches of (b)(4) Emulsion (b)(4) to the United States, despite the above violations, as well as others cited on the June 23, 2016 Form FDA-483.

CGMP consultant recommended

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. 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 ensuring 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 the causes, for preventing their recurrence, and for preventing other violations.

Until you correct all violations completely and we confirm your compliance with CGMP, FDA may withhold approval of any new applications or supplements listing your firm as a drug manufacturer.

Failure to correct these violations may also result in FDA refusing admission of articles manufactured at Route Des Jeunes 23, Carouge Ge, Geneva, 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).

After you receive this letter, respond to this office in writing within 15 working days. Specify what you have done since our inspection to correct your violations and to prevent their recurrence. If you cannot complete corrective actions within 15 working days, state your reasons for delay and your schedule for completion.

Send your electronic reply to [url=]CDER-OC-OMQ-Communications@fda.hhs.gov[/url] or mail your reply to:

Philip Kreiter, Public Health Analyst

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 1000488360.

Sincerely,

/S/

Francis Godwin

Acting Director

Office of Manufacturing Quality

Office of Compliance

Center for Drug Evaluation and Research

岳伟

说白了这个公司就没有质量管理体系，FDA还去审计？

zysx01234

楼上说的是，这个是个公司吗，一点GMP都不懂的样子

porsche1921

看样子是个实验室

scslk0045

怎么欧洲也有这样的企业？

zbpjy

天下的乌鸦一般黑啊

wuhuaguo54321

小作坊？？？？

vincentchampion

学习，路过

policeman

欧洲还有这样的药企？

小小鱼儿－12

这是家化妆品公司啊……FDA对化妆品的GMP要求也丝毫不含糊啊……
我对这家公司的产品有所了解，历史还挺悠久的，抗衰和生发产品做的很好，走美容沙龙渠道。其实，欧洲的化妆品公司没有特别严格的GMP要求，除非本公司自己申请各种认证，去年香港美博会上听他们的香港代理说过，FDA的检查主要是为了股东转换的商业行为，新的股东正在投入大量资金做GMP整改。
看来还是得苦练内功啊，以后监管会越来越细致……说不定哪天国内也开始对化妆品生产提出要求呢……到时又会是一番怎样的景象……