FDA Warns Chinese Drugmaker for Using Flagged Heparin Supplier, Restricting Access

October 17, 2014

The FDA slammed a Chinese active pharmaceutical ingredient (API) manufacturer for using a supplier of potentially contaminated heparin and for restricting access during an inspection.

The agency’s warning letter to Beijing Shunxin Meihua Bio-technical’s Beijing facility follows a February inspection that included a review of suppliers of heparin or heparin-related products. Investigators discovered that one of the suppliers is an alias for a company that is under an FDA import alert for making adulterated heparin, according to the letter.

It remains unclear whether the unnamed supplier was in fact linked to a 2008 scandal where deaths and adverse events were caused by Chinese-made heparin API contaminated with oversulfated chondroitin sulfate (OSCS).

However, the FDA did note that if Shunxin was supplied directly or indirectly by a company with a history of OSCS contamination or a lack of good manufacturing practices then any of Shunxin’s heparin-related products could be subject to import alert. Shunxin was already put on FDA import alert in July, effectively barring the API maker from shipping goods to the U.S.

The list of suppliers was one of the few records that Shunxin workers provided to agency investigators.

Company officials also barred the FDA access to the production area and other parts of the facility that makes crude heparin. In addition, the facility workers denied multiple FDA requests to review batch production records, according to the warning letter.

The agency was able to test two crude heparin samples and found contaminants in one of them.

The Sept. 29 warning letter deemed Shunxin’s products to be adulterated, meaning they could be seized by the FDA. Shunxin could not be reached for comment. The FDA did not return a request for comment as of press time.

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