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Fewer Observations, Shift In Emphasis Seen In FDA's Pandemic-Reduced Inspections

 
• By Bowman Cox

US agency mostly saw less of the same when it scaled back inspectional activity during COVID-19, but observed more training and equipment issues.

Inspector in plant
fda investigators observed some issues during the pandemic • Source: Alamy

As the COVID-19 pandemic wore on, US Food and Drug Administration investigators made even fewer inspectional observations regarding drug good manufacturing practices in fiscal year 2021 than in FY 2020.

The types of observations continued to hew closely to pre-COVID trends, although some changes in the top 10 drug GMP provisions cited were suggestive of recent trends, some of them COVID-related, that drug quality organizations should heed,

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