FDA Import alert for two Chinese companies

The European Union and US FDA have significantly increased their GMP inspections. So, more inspections are being performed outside their own territory. It became clear that manufacturing facilities located in India and China need to be investigated with more attention than in past. The non-compliance information is now better available in web as well as the collaboration between US and EU is a significant step towards a better control of manufacturing facilities.

FDA has issued an import alert for two Chinese manufacturers. The alert has been issued 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.

Some products manufactured by these companies are not allowed to enter US market. And the companies who may purchase products (e.g. APIs) from these manufacturing sites should not use these products for further processing. The name of the alert as mentioned in FDA site is “Detention without physical examination of drugs from Firms which have not met Drug GMPs"

Normally import alert is the next step or level when deviations mentioned in FDA Warning Letter have not been addressed as expected by the FDA. But it can also be issued if an inspection identifies so many critical findings that immediate action is necessary.