Vega Life Sciences Warning Letter Shows Difficulty Of Applying Drug GMPs To API Solvent Recyclers
Recycling offers economic and environmental benefits, but risks introducing potentially carcinogenic impurities. Company barred from US market.
You may also be interested in...
The US FDA managed to issue 94 drug GMP warning letters last year despite the pandemic, with fewer expected for 2021. Top issue areas included lack of sterility assurance, nitrosamine impurities, poor data integrity and basic GMP failures.
Concerned about another possible nitrosamine scare, the US FDA has sent a warning letter to Mylan focusing on the firm’s failure to control contamination risks of its APIs and inadequate testing of reused solvents.
Concerned about another possible nitrosamine scare, US FDA warning letter to Mylan focuses on firm’s failure to control contamination risks of its APIs and its inadequate testing of reused solvents.