FDA Warning Letter Recap
The US FDA released two warning letters in May related to the sale of unapproved COVID-19 tests.
Resolved quality systems problems and MDR violations lay behind the four device-related close-out letters posted online by the US FDA in May.
No device-related close-out letters were released by the US FDA last month.
The US FDA released five warning letters in April, all addressed to companies selling COVID-19 tests without agency clearance, approval or authorization.
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.
All set! This article has been sent to email@example.com.
All fields are required. For multiple recipients, separate email addresses with a semicolon.
Please Note: Only individuals with an active subscription will be able to access the full article. All other readers will be directed to the abstract and would need to subscribe.