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FDA Warning Letter Recap

FDA Warning Letter Recap, May 2021: COVID-19 Diagnostics Enforcement Continues

The US FDA released two warning letters in May related to the sale of unapproved COVID-19 tests.

Device Warning Letters FDA

FDA Warning Letter Close-Outs – May 2021

Resolved quality systems problems and MDR violations lay behind the four device-related close-out letters posted online by the US FDA in May.

Device Warning Letters FDA

FDA Warning Letter Close-Outs – April 2021

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

Device Warning Letters FDA

FDA Warning Letter Recap, April 2021: Crackdown On Unapproved COVID-19 Diagnostics Continues

The US FDA released five warning letters in April, all addressed to companies selling COVID-19 tests without agency clearance, approval or authorization.

Device Warning Letters FDA

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
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