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FDA Warning Letter Blasts Mylan’s Continued Lax Impurity Controls for APIs

Company Needs To Beef Up Equipment Cleaning And Monitoring Of Recovered Solvents For Impurities

 
• By Joanne S. Eglovitch

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.

Vintage inscription made by old typewriter, warning
FDA Tells Mylan To Learn From Earlier Mistakes • Source: Shutterstock

A warning letter the US Food and Drug Administration sent on 20 August to Mylan Pharmaceuticals Inc. targets the firm’s lax cleaning procedures for equipment holding and manufacturing active pharmaceutical ingredients and a failure to test reused solvents used to make APIs at the Mylan Unit 7 facility in Pashamylaram, India.

The warning letter underscores the FDA’s concern with the possibility of another nitrosamine scare that emerged from the 2018 discovery of carcinogenic nitrosamines in APIs for certain blood pressure...

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