Chinese API Maker That Sparked Valsartan Recall Gets a Close-Out of its FDA Warning Letter

The FDA has closed out its three-year-old warning letter to Zhejiang Huahai Pharmaceutical’s site in Linhai, Taizhou, because of corrective actions the manufacturer has undertaken. 

The Chinese active pharmaceutical ingredient (API) manufacturer was the first company implicated in a global recall of the contaminated heart drug valsartan.

The FDA hit Zhejiang Huahai with the warning letter in November 2018 for failing to adequately investigate the root cause of the n-nitrosodimethylamine (NDMA) contamination at its Taizhou facility.

“Based on our evaluation, it appears that you have addressed the deviations contained in this Warning Letter,” the FDA said in the close-out letter, adding that future FDA inspections and regulatory activities will further assess the adequacy and sustainability of the corrections the company has made. “The FDA expects you and your firm to maintain compliance and will continue to monitor your state of compliance,” said the agency.