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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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.
FDA officials say that process and supply chain risks are some of the root causes driving many of the nitrosamine contamination problems in recent months and manufacturers should work to contain and control these risks.
Agency guidance establishes process for ridding unsafe levels of the probable carcinogens from the pharmaceutical supply chain.