Fiscal year (FY) 2019 was a fascinating year for drug GMP warning letters in the diversity of topics addressed, depth of focus, and trends in enforcement actions. This article presents a comprehensive summary of the drug GMP warning letters issued in FY2019, including an evaluation of trends since FY2013. The data presented for FY2019, ending Sept. 31, 2019, is based on drug GMP warning letters posted by the FDA no later than Jan. 20, 2020.

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