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FDA Warning Letter Recap

FDA Warning Letter Close-Outs – March 2021

Surgical sealant firm Ocular Therapeutix received the only device-related close-out letter posted online by the US FDA last month.

Device Warning Letters FDA

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.

Device Warning Letters FDA

FDA Warning Letter Close-Outs – February 2021

No device-related close-out letters were released by the US FDA last month.

Device Warning Letters FDA

FDA Warning Letter Recap – 23 February 2021

No device-related warning letters were released by the US FDA the week of 23 February.

Device Warning Letters FDA

FDA Inspections All But Stopped In 2020 – But Quality-Related Warning Letters Kept On Coming

The US agency sent 21 of the letters to device makers last year – the same number it mailed to firms in 2019.

Device Warning Letters FDA

FDA Warning Letter Recap – 16 February 2021

No device-related warning letters were released by the US FDA the week of 16 February.

Device Warning Letters FDA
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