Thursday, 17 October 2019 14.00 - 15.30 h
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. The collaboration 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