WHO response to the USFDA import alert issued for Qinhuangdao Zizhu Pharmaceutical Co Ltd, Active Pharmaceutical Ingredient (API) manufacturing site

On 8th March 2017, Qinhuangdao Zizhu Pharmaceutical  was placed on the import alert by the USFDA.

The Good Manufacturing Practice (GMP) inspection was carried out by the USFDA at Qinhuangdao Zizhu Pharmaceutical, No. 10, Longhai Avenue, Economic Development Zone, Qinhuangdao, Hebei, China 066004 on 28 November to 1 December 2016. The inspection found failures in the level of adherence to cGMP for APIs. In particular, the USFDA inspection team discovered a breach of data integrity related to testing in the Quality Control laboratory.

For more detailed information, see below attached document