The FDA has issued a warning letter to Zhejiang Huahai Pharmaceutical Co. Ltd. detailing violations at its facility that manufactures the active ingredient in valsartan, which is used to treat patients with high BP and HF.
The active ingredient in valsartan is currently being investigated by the FDA for impurities that potentially cause cancer. Violations regarding the company’s production of valsartan include change control, impurity control and cross-contamination from one manufacturing process line to another, according to a press release from the FDA.
This activity is supported by an independent educational grant from Amarin Pharma Inc.
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