FDA本月发给四川一家药厂的警告信

qjluo

http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm272791.htm

Warning Letter

VIA UPS MAIL

WL: 320-11-019

September 09, 2011
Mr. Wang Gouping
General Manager
Sichuan Pharmaceutical Co., Ltd.
No. 189 Hualong Road
Pengzhou, Sichuan, China 611930
Dear Mr. Gouping:
During our June 23 to 29, 2010 inspection of your active pharmaceutical ingredient (API) manufacturing facility, Sichuan Pharmaceutical Co., Ltd. located at No. 189 Hualong Road, Pengzhou, Sichuan, China, an investigator from the Food and Drug Administration (FDA) identified significant deviations from Current Good Manufacturing Practice (CGMP) for the manufacture of APIs. These deviations cause your API(s) to be adulterated within the meaning of section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 351(a)(2)(B)] in that the methods used in, or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with, CGMP.
We have reviewed your firm’s response of August 05, 2010 and December 13, 2010, and note that it lacks sufficient corrective actions.
Specific deviations observed during the inspection include, but are not limited, to the following:

1. Failure to have appropriate procedures in place to prevent cross-contamination.

From September 2008 to July 2009 your firm manufactured (b)(4) API in workshop (b)(4), which is adjacent to workshops (b)(4) and (b)(4) where you manufactured (b)(4) API and (b)(4) injection, respectively. However, you failed to have adequate controls and monitoring program to prevent cross-contamination between these adjacent workshops.

In addition, your firm manufactures a (b)(4) API ((b)(4) (API) in a facility that was previously used to manufacture (b)(4) without conducting adequate decontamination, renovation, and activation of the facility. Your firm has failed to conduct adequate assessment of the cross-contamination risks.
Please note that analytical testing of a product for possible contamination with (b)(4) is not sufficient to ensure adequate conditionsfor (b)(4) manufacture. In your response to this letter include your plans for decontamination, renovation, and reactivation (if appropriate) of your facility including the decontamination agent, decontamination plans, analytical methodology for environmental and product testing, and the data obtained to support the effectiveness of the decontamination plan.
The deviations detailed in this letter are not intended to be an all-inclusive statement of deviations that exist at your facility. You are responsible for investigating and determining the causes of the deviations identified above and for preventing their recurrence and the occurrence of other deviations. If you wish to continue to ship APIs to the United States, it is the responsibility of your firm to ensure compliance with all U.S. standards for CGMP and all applicable U.S. laws and regulations.

Additionally, your firm is neither registered nor has it listed every API in commercial distribution in the United States with FDA, as required by 21 C.F.R. § 207.40 and section 510(i) of the Act [21 U.S.C. § 360(i)]. Information on how to register and list is available at the following internet website: http://www.fda.gov/cder/drls/registration_listing.htm1. You must complete the required registration and listing and provide evidence that you have fulfilled these requirements in your response to this letter.

Until all corrections have been completed and FDA has confirmed corrections of the deviations and your firm’s compliance with CGMP, FDA may withhold approval of any new applications or supplements listing your firm as an API manufacturer. In addition, failure to correct these deviations may result in FDA refusing admission of articles manufactured at Sichuan Pharmaceutical Co., Ltd. located at No. 189 Hualong Road, Pengzhou, Sichuan, China into the United States. The articles are subject to refusal of admission pursuant to section 801(a)(3) of the Act [21 U.S.C. § 381(a)(3)] in that the methods and controls used in their manufacture do not appear to conform to Current Good Manufacturing Practice within the meaning of section 501(a)(2)(B) of the Act [21 U.S.C. § 351(a)(2)(B)].
Within fifteen working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to correct deviations. Include an explanation of each step being taken to prevent the recurrence of deviations and copies of supporting documentation. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the date by which you will have completed the correction.
Additionally, your response should state if you no longer manufacture or distribute (b)(4) API and provide the date(s) and reason(s) you ceased production. Please identify your response with FEI # 3002808073.
If you have questions or concerns regarding this letter, contact Milva E. Meléndez, Compliance Officer, at the below address and telephone number.

U.S. Food and Drug Administration
Center for Drug Evaluation and Research
Office of Manufacturing and Product Quality
Division of International Drug Quality
White Oak, Building 51
10903 New Hampshire Ave
Silver Spring, MD 20993
Tel: (301) 796-0662
Fax: (301) 847-8741

Sincerely,
/Steven Lynn/
Steven Lynn
Director
Office of Manufacturing and Product Quality
Office of Compliance
Center for Drug Evaluation and Research

herry

要是有中文版就更好了！

liwei1248

看不懂啊

lnzy

要是再给翻译一下就更好了，哈哈

chenkaiyi

大概意思是，四川这个药厂生产的原料药存在交叉污染的风险，企业之前给的答复和改进，没有得到FDA官员的认可，需重新整改吧。

LGQ111

今晚有空译一下

LGQ111

信的主要内容如下：
在我们于2010年6月23日至29日对贵公司现场生产活性药物成分API的检查中，发现贵公司与现行版美国GMP法规出现了严重的偏离。这些偏离导致你们的API受到掺杂（法规501章节中所指掺杂）。该法规适用于厂房设施，生产管理，监控，加工，包装或监管不依法执行GMP生产，管理、监控的各种情况。
我们已于2010年8月5日和2010年12月13日对贵公司进行复检，发现贵公司仍未进行足够的整改。上次检查中发现的偏离情况仍然存在，并没有减少。例如：1、缺少适当的在线控制交叉污染的程序措施。贵企业于2008年9月至2009年7月在车间生产（b）（4）API，同时邻近的车间生产针剂，但贵企业不能充分的管理并监控以防止它们之间的交叉污染。另外，贵企业生产（b）（4）API的设施，以前是生产（b）（4）的，也未能对该设施进行有效的清场、去污、去除活性成分。贵公司未能对交叉污染的风险进行充分的评估。
请注意为确保生产（b）（4）的生产条件不受到污染而对产品进行分析检测。贵公司对本涵的回复内容应包括：清场去污计划，整改纠偏措施（包括负责人，计划，检测分析，环境监控，产品检验以及支持此清场去污措施的有效性的各项数据。
在这里不对贵公司的所有偏离CGMP详情一一详述。请们尽职检查并防止上述偏离的再次发生或别的偏离情况发生。如贵公司还想出售APIs到美国，你们必须确保你们的产品符合美国标准，你们的生产活动符合美国联邦CGMP等各项法律法规。另外，贵公司既没有注册也没有按美国FDA的要求进行销售备案，备案网址：http://www.fda.gov/cder/drls/registration_listing.htm1.你们必须按该网要求完成注册及备案，并在回复中提供相应已完成注册的证明文件。除非FDA已确认贵公司已纠正了偏离CGMP的情况，否则FDA不会对贵公司新申请API或补充申请进行批准。另外，如不能纠正偏离也会导致FDA无法批准贵公司的产品进入美国销售（法律法规省略）。
收到本信15个工作日内请答复。答复包括：贵公司已采取的纠偏措施，包括每一步防止偏离再次发生的步骤以及各种证明文件。如贵公司不能在15个工作日内完成上述工作，请说明延迟理由及将要整改日期。另外，如果已停止生产（b）（4），也请提供停止生产日期及缘由。
如有任何问题或异议，请联系美国U.S. Food and Drug Administration  Milva E. Meléndez, Compliance Officer 地址   。

sinofsb

2011 9 9发的警告信
API的厂家都要引以为戒呀
FDA可不是闹着玩的

sinofsb

人家拿着纳税人的钱，是真心为纳税人服务和负责的，不像.............................................nidongde

phoebe_f

引以为戒