FDA places Zhejiang Huahai Pharmaceuticals on import alert

Following a recent inspection of the company's facility, FDA has prohibited imports of active pharmaceutical ingredient (API) from Zhejiang Huahai Pharmaceuticals of China. The company is involved in the tainted valsartan situation. The import alert, issued on September 28, is intended "to protect U.S.

Following a recent inspection of the company's facility, FDA has prohibited imports of active pharmaceutical ingredient (API) from Zhejiang Huahai Pharmaceuticals of China. The company is involved in the tainted valsartan situation. The import alert, issued on September 28, is intended "to protect U.S. patients" while the company "fully determines how impurities were introduced into its API and remediates its quality systems." The import alert halts all ZHP-made API and finished drug products using the company's API from legally entering the United States. FDA reminded manufacturers about "their responsibility to develop and use suitable methods to detect impurities, including when they make changes to their manufacturing processes."