翻譯：Julia朱玉姣 來自：蒲公英
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.
FDA于2016年6月20-23日檢查了你們位于瑞士日內瓦的工廠。
This warning letter summarizes significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. See 21 CFR, parts 210 and 211.
本警告信總結了你們制劑生產(chǎn)中嚴重違背CGMP的情況。參見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 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).
由于你們生產(chǎn)、加工、包裝和存貯藥品的方法、場所或控制不符合CGMP，你們的藥品根據(jù)FDCA，21 U.S.C. 351(a)(2)(B)第501(a)(2)B)的規(guī)定被認定為摻假藥品。
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.
我們詳細審核了你們于2016年7月5日發(fā)來的回復。在回復中你們說你們生產(chǎn)的某OTC藥品已停止生產(chǎn)。你們沒有承諾會持續(xù)知會FDA某進展情況。你們還沒有向FDA提供任何書面證據(jù)來證明某事已發(fā)生。
During our inspection, our investigator observed specific violations including, but not limited to, the following.
在我們檢查期間，我們的調查人員發(fā)現(xiàn)的具體違規(guī)情況包括但不僅限于以下：
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.
貴公司未能為質量控制部門建立書面的職責和程序，包括對OOS結果和客戶投訴的審核(21 CFR 211.22(d))。在檢查期間，你們說你們沒有獨立的質量部門。
2. You failed to test finished batches of your drug products for the identity and strength of active ingredients. (21 CFR 211.165(a))
貴公司沒有檢測你們藥品成品批次的活性成分的鑒別和劑量。(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))
貴公司未能確保來自不同供應商的成分的鑒別，包括你們的XX活性成分。(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).
貴公司沒有按照適當?shù)闹芷谇鍧嵑途S護你們的某設備防止其發(fā)生故障或對你們的藥品形成污染。(21 CFR 211.67(d))。在檢查期間，我們在你們某設備上發(fā)現(xiàn)連續(xù)的棕紅色銹。
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.
貴公司沒有為生產(chǎn)和工藝控制建立書面程序，包括驗證方案和報告，用以確保你們的藥品具備其所既定的鑒別、劑量、質量和純度。(21 CFR 211.100(a))。在檢查期間，你們說你們公司沒有工藝驗證程序。
6. You have no da
你們沒有數(shù)據(jù)證明你們產(chǎn)品的理化特性在其貨架期間是能保持可以接受。(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.
在有上述違規(guī)情況，以及6月23日簽發(fā)的483表中所述違規(guī)情況的前提下，你們將至少XX批次的YY產(chǎn)品銷售至美國。
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 on
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 CDER-OC-OMQ-Communications@fda.hhs.gov 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
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