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Warning Letter Roundup & Recap

Warning Letter Roundup & Recap – 21 January 2020

A maker of low-level LED light-therapy devices was cited by the US FDA for premarket, quality systems and Medical Device Reporting violations. It's just one of two device-related warning letters released by the agency this week.

Device Warning Letters FDA

Warning Letter Roundup & Recap – 14 January 2020

No device-related warning letters were released by the US FDA the week of 14 January.

Device Warning Letters FDA

Warning Letter Roundup & Recap – 7 January 2020

No device-related warning letters were released by the US FDA the week of 7 January.

Device Warning Letters FDA

Warning Letter Roundup & Recap – December 2019

The US FDA released two device-related warning letters last month. One was sent to the maker of sterile orthopedic implants; the other to a manufacturer of surgical trays and kits. Both were cited by the agency for quality systems violations.

Device Warning Letters FDA

Warning Letter Close-Outs – December 2019

The US FDA released one device-related close-out letter in December.

Device Warning Letters FDA

Warning Letter Roundup & Recap – 10 December 2019

No device-related warning letters were released by the US FDA the week of 10 December.

Device Warning Letters FDA

Warning Letter Roundup & Recap – 3 December 2019

In the only device-related warning letter released by the US FDA this week, a manufacturer of surgical trays and kits was cited for quality systems violations.

Device Warning Letters FDA

Warning Letter Close-Outs – November 2019

The US FDA released one device-related close-out letter in November.

Device Warning Letters FDA

Warning Letter Roundup & Recap – 26 November 2019

No device-related warning letters were released by the US FDA the week of 26 November.

Device Warning Letters FDA

Warning Letter Roundup & Recap – 19 November 2019

A manufacturer of in vitro diagnostic reagents was cited for premarket violations in the only device-related warning letter released by the US FDA this week.

Device Warning Letters FDA

Warning Letter Roundup & Recap – 12 November 2019

No device-related warning letters were released by the US FDA the week of 12 November.

Device Warning Letters FDA

Warning Letter Roundup & Recap – 5 November 2019

No device-related warning letters were released by the US FDA the week of 5 November.

Device Warning Letters FDA
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