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Warning Letter Roundup & Recap

Warning Letter Roundup & Recap – Sept. 18, 2018

The maker of wound-dressing product Omiderm was cited for quality systems violations in the only device-related warning letter released by US FDA this week.

Device Warning Letters FDA

Warning Letter Roundup & Recap – Sept. 11, 2018

Medtronic is the recipient of two warning letters following unfavorable FDA inspections at its Minnesota and Puerto Rico facilities. The missives were the only device-related letters released by the US agency this week.

Device Warning Letters FDA

Warning Letter Close-Outs – August 2018

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

Device Warning Letters FDA

Warning Letter Roundup & Recap – Sept. 4, 2018

Zimmer Biomet dinged for quality systems violations in the only device-related warning letter released by US FDA this week.

Device Warning Letters FDA

Warning Letter Roundup & Recap – Aug. 28, 2018

No device-related warning letters were released by US FDA the week of Aug. 28.

Device Warning Letters FDA

Warning Letter Roundup & Recap – Aug. 21, 2018

No device-related warning letters were released by US FDA the week of Aug. 21.
Device Warning Letters FDA

Warning Letter Roundup & Recap – Aug. 14, 2018

No device-related warning letters were released by US FDA the week of Aug. 14.
Device Warning Letters FDA

Warning Letter Roundup & Recap – Aug. 7, 2018

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

Device Warning Letters FDA

Warning Letter Close-Outs – July 2018

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

Device Warning Letters FDA

Warning Letter Roundup & Recap – July 31, 2018

US FDA noted quality systems violations by menstrual cup-maker Anigan Inc. in the first device-related warning letter released by the agency in more than two months.

Device Warning Letters FDA

Warning Letter Roundup & Recap – July 24, 2018

No device-related warning letters were released by US FDA the week of July 24.

Device Warning Letters FDA

Warning Letter Roundup & Recap – July 17, 2018

No device-related warning letters were released by US FDA the week of July 17.

Device Warning Letters FDA
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