FDA Found Repeat Quality Deficiencies at Valsartan Manufacturer’s Facility
In another twist in the worldwide recall of the contaminated blood pressure medication, valsartan, the FDA released two Form 483 reports issued to the API’s manufacturer in China after inspections in 2016 and 2017.
In July, Zhejiang Huahai discovered that an impurity and possible human carcinogen, N-nitrosodimethylamine (NDMA), contaminated the API, resulting in U.S. and EU reviews of the active ingredient and recalls of numerous medicines. NDMA is a by-product of several industrial processes and can be present at very low levels in water and certain foods.
The 483s identify shortcomings in the facility’s quality practices, such as shoddy equipment cleaning and disinfecting in processing areas, as well as poor documentation of impurities found during analytical testing.