【讨论】FDA issues Import Alert for two Chinese Companies

zhulikou431

The US FDA and the European Union have increased their GMP Inspection Systems significantly. As a result more inspections are being performed outside their own territory. It became visible that manufacturing sites located in China and India need to be monitored with more attention than in the past. The pharmaceutical legislation but especially the supervision/inspection systems in these countries do not have the same quality as those in the EU and the US. Thecollaboration between the US and EU as well as the fact that non-compliance information is now better available via the web is a significant step towards a better control of manufacturing sites.
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.
Source: FDA Import Alert

zhulikou431

Zhejiang Jiuzhou Pharmaceutical Co., Ltd.
Date Published : 03/18/2014
No. 99 Waisha Road , Taizhou, Zhejiang Prov., Zhejiang CHINA
55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 03/18/2014
Notes:All Drug Products
56 - - - -- Antibiotics (Human/Animal)
Date Published: 03/18/2014
Notes:All Drug Products
60 - - - -- Human and Animal Drugs
Date Published: 03/18/2014
Notes:All Drug Products
61 - - - -- Human and Animal Drugs
Date Published: 03/18/2014
Notes:All Drug Products
62 - - - -- Human and Animal Drugs
Date Published: 03/18/2014
Notes:All Drug Products
63 - - - -- Human and Animal Drugs
Date Published: 03/18/2014
Notes:All Drug Products
64 - - - -- Human and Animal Drugs
Date Published: 03/18/2014
Notes:All Drug Products
65 - - - -- Human and Animal Drugs
Date Published: 03/18/2014
Notes:All Drug Products
66 - - - -- Human and Animal Drugs
Date Published: 03/18/2014
Notes:All Drug Products
Zhejiang Zonebanne
Date Published : 03/18/2014
Waisha Road 99 Jia , Taizhou, CHINA
55 - - - -- Pharm Necess & Ctnr For Drug/Bio
Date Published: 03/18/2014
Notes:All Drug Products
56 - - - -- Antibiotics (Human/Animal)
Date Published: 03/18/2014
Notes:All Drug Products
60 - - - -- Human and Animal Drugs
Date Published: 03/18/2014
Notes:All Drug Products
61 - - - -- Human and Animal Drugs
Date Published: 03/18/2014
Notes:All Drug Products
62 - - - -- Human and Animal Drugs
Date Published: 03/18/2014
Notes:All Drug Products
63 - - - -- Human and Animal Drugs
Date Published: 03/18/2014
Notes:All Drug Products
64 - - - -- Human and Animal Drugs
Date Published: 03/18/2014
Notes:All Drug Products
65 - - - -- Human and Animal Drugs
Date Published: 03/18/2014
Notes:All Drug Products
66 - - - -- Human and Animal Drugs
Date Published: 03/18/2014
Notes:All Drug Products
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羟丙基甲基纤维素（HPMC）

zhulikou431

CFDA也在逐渐增强境外现场检查的力度，从2011至今的战绩看，查出有问题的外企也不少，不仅仅是注册和法规方面的问题，GMP和质量方面的问题有。

zhulikou431

浙江九洲制药于21/10-24/10/2013 受FDA检查并收到483表
FDA已在 29/10-01/11/2007, 18/04-21/04/2011检查浙江九洲制药并发483表

wangjin1023

就应该严肃点

cq254032003

以前在这家公司隔壁干过