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2020 In Review: Despite Pandemic, The US FDA Issued Just 20% Fewer Drug GMP Warning Letters

2021 warning letter rate could decline further

 
• By Joanne S. Eglovitch

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.

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Majority Of FDA's GMP Warning Letters Hit Domestic Firms Last Year

The rate at which the US Food and Drug Administration issued drug good manufacturing practices warning letters declined by just 20% from 118 in 2019 to 94 in 2020 despite a global pandemic that led the agency to suspend most inspections late in the first quarter.

The rate would have been lower but for 14 non-inspection-based drug GMP warning letters to Mexican companies trying to meet...

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