US FDA Warning Letter Hits Huahai For Failure To Prevent Valsartan Contamination
Executive Summary
Zhejiang Huahai should have realized its valsartan API was tainted by the probable carcinogen NDMA, FDA says in warning letter, despite earlier statement from agency leadership to the contrary.
You may also be interested in...
FDA: Key FY 2019 Warning Letter Trend Is Inadequate Testing For API Impurities
This year’s 89 warning letters so far hit API testing for nitrosamines, aseptic facility design, contaminated water, API traceability and more.
House Committee Wants Answers On Foreign Inspections And Valsartan Crisis
A bipartisan group of lawmakers is concerned about the growing number of recalls of blood pressure medicines from foreign manufacturing sites in China and India and wants answers from GAO and FDA.
The Reaction To Valsartan Impurities: More Scrutiny, More Testing And Tighter Limits
In the months since US and EU authorities restricted Zhejiang Huahai’s market access over the discovery of nitrosamine impurities in its valsartan API, the broader regulatory consequences for drug manufacturers are coming into focus.