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.
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.
FDA Warning Letter Close-Outs – April 2021
No device-related close-out letters were released by the US FDA last month.
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.
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.
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.
You must sign in to use this functionality
Authentication.SignIn.HeadSignInHeader
Email Article
All set! This article has been sent to my@email.address.
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.