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Warning Letter Roundup & Recap

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

Warning Letter Close-Outs – October 2019

The US FDA released two device-related close-out letters in October.

Device Warning Letters FDA

Warning Letter Roundup & Recap – 29 October 2019

No device-related warning letters were released by the US FDA the week of 29 October.

Device Warning Letters FDA

Warning Letter Roundup & Recap – 22 October 2019

No device-related warning letters were released by the US FDA the week of 22 October.

Device Warning Letters FDA

Warning Letter Roundup & Recap – 15 October 2019

In the only device-related warning letter released by the US FDA this week, a manufacturer of a dental X-ray sensor and X-ray system was cited for quality systems violations. The firm also failed to notify the agency of accidental radiation occurrences.

Device Warning Letters FDA

Warning Letter Roundup & Recap – 8 October 2019

No device-related warning letters were released by the US FDA the week of 8 October.

Device Warning Letters FDA

Warning Letter Close-Outs – September 2019

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

Device Warning Letters FDA
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