The U.S. Food and Drug Administration (FDA) issued a warning letter to the Chinese drug manufacturer of the active ingredient in valsartan, a drug used for blood pressure and heart problems. The letter is another step in the FDA-led investigation of the drugmaker, that began in July.
The FDA’s letter was addressed to Zhejiang Huahai Pharmaceutical Co. Ltd. (ZHP) and “outlines several manufacturing violations at ZHP’s Chuannan facility, including impurity control, change control, and cross-contamination from one manufacturing process line to another,” the agency said. The root cause of cancer-causing impurities is being investigated by the FDA, it said Dec. 11.
