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Warning Letter Roundup & Recap

Warning Letter Roundup & Recap – 21 August 2019

A maker of in vitro diagnostics was dinged for premarket, quality systems, Medical Device Reporting and corrections & removals violations. It's just one of two device-related warning letters released by the US FDA this week.

Device Warning Letters FDA

Warning Letter Roundup & Recap – 13 August 2019

A maker of medical equipment, health-care supplies, and radiation products used for general and plastic surgery was cited for quality systems violations in the only device-related warning letter released by the US FDA this week.

Device Warning Letters FDA

Warning Letter Roundup & Recap – 6 August 2019

No device-related warning letters were released by the US FDA the week of 6 August.

Device Warning Letters FDA

Warning Letter Close-Outs – July 2019

The US FDA released three device-related close-out letters in July.

Device Warning Letters FDA

Warning Letter Roundup & Recap – 30 July 2019

No device-related warning letters were released by the US FDA the week of 30 July.

Device Warning Letters FDA

Warning Letter Roundup & Recap – 23 July 2019

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

Device Warning Letters FDA

Warning Letter Roundup & Recap – 16 July 2019

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

Device Warning Letters FDA

Warning Letter Roundup & Recap – 9 July 2019

No device-related warning letters were released by the US FDA the week of 9 July.

Device Warning Letters FDA

Warning Letter Close-Outs – June 2019

The US FDA did not release any device-related close-out letters in June.

Device Warning Letters FDA

Warning Letter Roundup & Recap – 2 July 2019

No device-related warning letters were released by the US FDA the week of 2 July.

Device Warning Letters FDA

Warning Letter Roundup & Recap – 25 June 2019

In the only device-related warning letter released by the US FDA this week, a maker of Baker Jejunostomy tubes and intestinal tubes used for bowel decompression was cited for quality systems violations.

Device Warning Letters FDA

Warning Letter Roundup & Recap – 18 June 2019

No device-related warning letters were released by the US FDA the week of 18 June.

Device Warning Letters FDA
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