Former FDA Inspector On Valsartan Recalls

Former FDA Inspector On Valsartan Recalls

Introduction

According to a news report, former FDA inspector Massoud Motamed said that he had warned about problems with valsartan manufacturing facilities in China and India at least a year before the recall began, but he was ignored.

Zhejiang Huahai Pharmaceutical Co. in China and Hetero Labs in India manufactured the recalled valsartan ingredients. Motamed inspected the Zhejiang Huahai plant in China in May 2017 and found a number of alarming problems, including unknown impurities that were reportedly dismissed as laboratory errors. He had recommended sending a warning letter to the facility, but it was overruled by FDA management, allowing the plant to fix the problems voluntarily. A year later, the agency began forcing the company’s drugs to be recalled and placed import restrictions on all its products. This impacted most of the U.S. supply for the blood pressure drug.

Valsartan drug manufacturers and distributors are currently facing around 100 product liability lawsuits with claims that the distributed version of valsartan was contaminated with carcinogenic substances, including N-nitrosodimethylamine (NDMA) and N-Nitrosodiethylamine (NDEA), which happens to be a by-product of the generic drug manufacturing process.