FDA Warning Letter Recap, March 2021: Unapproved COVID-19 Products Lead To Surge In Enforcement Letters

The US FDA handed out 15 warning letters in March to manufacturers of various products that were unapproved to mitigate or prevent COVID-19. Meanwhile, a 16th letter – the output of a 2019 facility inspection by the agency – led to quality system violations for a maker of wound dressings. The device-related letters are the first posted online by the FDA since December 2020.

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This chart lists device-related warning letters released by the US Food and Drug Administration in March 2021. If an inspection led to the warning letter, the location of the inspected...

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