FDA spotted quality defects at valsartan manufacturer almost 2 years before recall

FDA has released two Form 483s that were sent to Zhejiang Huahai Pharmaceuticals in November 2016 and May 2017. The Chinese company is the manufacturer at the center of the U.S. and E.U. recalls of valsartan.

FDA has released two Form 483s that were sent to Zhejiang Huahai Pharmaceuticals in November 2016 and May 2017. The Chinese company is the manufacturer at the center of the U.S. and E.U. recalls of valsartan. The first Form 483 cited Zhejiang Huahai for four observations, including a failure to use written procedures to prevent contamination and deficient systems for cleaning and disinfecting equipment, while the second Form 483 questioned the integrity of the company's analytical testing. In addition, the report noted repeat testing of the same active pharmaceutical ingredient batch without investigating the first test results. On Friday, the European Medicines Agency reported that it has become aware of low levels of N-nitrosodimethylamine (NDMA) in the valsartan active substance manufactured by a second company, Zhejiang Tianyu.