FDA Warning Letter Recap
Surgical sealant firm Ocular Therapeutix received the only device-related close-out letter posted online by the US FDA last month.
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.
No device-related close-out letters were released by the US FDA last month.
No device-related warning letters were released by the US FDA the week of 23 February.
The US agency sent 21 of the letters to device makers last year – the same number it mailed to firms in 2019.
No device-related warning letters were released by the US FDA the week of 16 February.
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