FDA Warning Letter Blasts Mylan’s Lax API Impurity Controls
Cites Equipment Cleaning And Monitoring Of Recovered Solvents For Impurities
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.
You may also be interested in...
Mylan Hits Back At ‘Misleading’ FDA Warning Letter
Mylan has hit back at “misleading information” circulating in connection with a recent FDA warning letter – including some statements within the letter itself – as it highlighted its proactive efforts in investigating “all potential risks associated with inquiries related to nitrosamine impurities.”
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.
Mylan Warning Letter Exposes Challenges In Valsartan Supply Chain Chemistry
Nitrosamines taint Mylan’s valsartan API solvent recovery, whether outsourced or in-house; firm mulls US FDA's request for ‘material systems review.’