中国浙江某生产商被FDA发布警告信-节译

2016-08-18蒲公英

作者：julia朱玉姣 来源：蒲公英

原文网址：http://www.fda.gov/ICECI/Enforce .../2016/ucm516163.htm

WarningLetter 320-16-24

Via UPS

Return Receipt Requested

August 4, 2016

Mr. Jiang Xiao Yue

CEO

Zhejiang Medicine Co. Ltd.

Xinchang Pharmaceutical Factory

Floor 3, Building A Kechuangyuan

398 Mahuan Road, Binhaixincheng

Shaoxing, Zhejiang 312366

China

Dear Mr. Yue:

The U.S. Food and Drug Administration (FDA)inspected yourdrug manufacturing facility, Zhejiang Medicine Co., Ltd.,XinchangPharmaceutical Factory, at 98 East Xinchang Dadao Road, Xinchang,Zhejiang, fromJune 15–18, 2015.

FDA于2015年6月15-18日检查了你们位于浙江新昌的工厂。

This warning letter summarizes significant deviationsfromcurrent good manufacturing practice (CGMP) for active pharmaceuticalingredients(API).

此警告函总结了原料药偏离CGMP要求的重大缺陷。

Because your methods, facilities, or controlsformanufacturing, processing, packing, or holding do not conform to CGMP, yourAPIare adulterated within the meaning of section 501(a)(2)(B) of the FederalFood,Drug, and Cosmetics Act (the FD&C Act), 21 U.S.C. 351(a)(2)(B).

由于你们生产、加工、包装或存贮的方法、设施或控制不符合CGMP要求，你们的原料药被认为是掺假药。

详见附件