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.
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
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.
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