Author: Barbara W. Unger


FDA Warning Letters Week of 8/30/2020: Cleaning Validation Issues & Adulterated Products at CMO

Last week, FDA posted two Warning Letters to drug firms. One has already received considerable attention. This one was issued to one of Mylan’s sites in India and is similar to one the company received for another Indian site last year. Additionally, the Warning Letter addresses similar concerns as one issued to a U.S. Mylan site in 2018. That Warning Letter cited issues with solvent recovery and cleaning validation.

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