【讨论】FDA对中国二家制药企业发布进口禁令

zhulikou431

FDA对中国二家制药企业发布进口禁令
2014年3月18日，FDA没有公开发布警告信就给中国两家原料药厂发布了进口禁令，可见违背cGMP问题的严重性。这二家公司都来自浙江台州，即浙江九洲制药有限公司和浙江中贝（也叫九洲中贝），禁令包括所有的产品，美国境内制剂药厂过去已进口这二家公司的API也不允许用于制剂生产。
事态会进一步发酵，很有可能欧盟也使用FDA的检查报告也对这二家公司做出同样的决定。
Now the FDA has issued an Import Alert for two Chinese manufacturers. An Import Alert is normally the next escalation level when deviations referenced in FDA Warning Letter have not been addressed as expected by the FDA. But Import Alerts can also be issued if an inspection identifies so many critical findings that immediate action is necessary. On 18 March 2014 the FDA issued the Import Alert for Zhejiang Jiuzhou Pharmaceutical Co., Ltd, No. 99 Waisha Road, Taizhou, Zhejiang Prov., Zhejiang CHINA and on the same day for Zhejiang Zonebanne Waisha Road 99 Jia , Taizhou, CHINA.
Certain Products manufactured by these companies are not allowed to enter the US territory. All companies who may purchase products from these manufacturing sites (e.g. APIs) should not use these products for further processing. It is likely that EU authorities will use the inspections report from FDA to make their own decisions. Due to a secrecy agreement between EU and US inspection information will be shared between the authorities.
消息来源：http://www.gmp-compliance.org/eca_news_4213_8447,S-QSB.html
FDA进口禁令链接：http://www.accessdata.fda.gov/cms_ia/importalert_189.html

玻璃杯

有可能还有更深的原因，我朝的原料药，质量还是不错的，特别是出口的企业，还是有底线的，哎，八成躺枪了

彩虹

出口药品生产企业也面临严峻挑战啊

孙艳红

通过检查后的持续高标准的管理是不能松懈的