Health Canada, FDA and EMA list Zhejiang Huahai Pharmaceuticals as non-compliant after inspection

Health Canada announced that it has found the the Chuannan manufacturing site of Zhejiang Huahai Pharmaceuticals to be non-compliant with the requirements for Good Manufacturing Practice (GMPs) of active pharmaceutical ingredients (API), basing its decision on an inspection carried out by the Food and Drug Administration (FDA) in August 2018. This follows on from its recall of all drugs containing valsartan manufactured by Zhejiang Huahei Pharmaceuticals due to possible contamination with a likely carcinogen, as reported by MAP BioPharma here.

A non-compliant rating means that Canadian companies are not able to import drugs containing an API from the Chuannan site unless there is a medical necessity.

On a related note, the FDA has clarified a discrepancy relating to its own decision on the subject, which arose as a result of a mistake in its communications. Its import alert lists an import ban on the company’s Chuannan site, while its website states a ban on all goods manufactured by the company. The FDA has confirmed that the ban only applies to the Chuannan site.

In a press release, the European Medical Agency (EMA) confirmed that it too has placed an import ban on APIs from the Chuannan site as a result of its own independent inspection, citing non-compliance with GMP.

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Published 15. October 2018 in News Canada, News EU