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Warning Letter Roundup & Recap

Warning Letter Roundup & Recap – Oct. 17, 2017

US FDA issued two device-related warning letters this week detailing quality systems issues at a dialysis supply manufacturer and a facial prosthetics company.

Device Warning Letters Regulation

Warning Letter Roundup & Recap – Oct. 10, 2017

US FDA issued two device-related warning letters this week addressing concerns at a Swedish diagnostics company and a New Jersey manufacturer of dialysis supplies.

Medical Device Regulation

Warning Letter Roundup & Recap – Oct. 3, 2017

US FDA addressed quality system violations at a hemodialysis product manufacturer in the only device-related warning letter posted this week.

Medical Device Device Warning Letters

Warning Letter Close-Outs – September 2017

US FDA released five device-related close-out letters in September.

Medical Device Device Warning Letters

Warning Letter Roundup & Recap – Sept. 26, 2017

US FDA did not release any device-related warning letters the week of Sept. 26.

Device Warning Letters Regulation

Warning Letter Roundup & Recap – Sept. 19, 2017

The only device-related warning letter posted this week by US FDA discusses quality system violations at a Wisconsin maker of organ preservation systems.

Medical Device Regulation

Warning Letter Roundup & Recap – Sept. 12, 2017

US FDA posted two device-related warning letters this week, discussing quality system violations at a Pfizer subsidiary and the marketing of an unapproved stroke recovery device.

Device Warning Letters Medical Device

Warning Letter Roundup & Recap – Sept. 5, 2017

US FDA broke a six-week dry spell by finally posting a handful of device-related warning letters online this week, touching on problematic complaint handling practices, marketing of unapproved devices and a bevy of quality systems violations. All six letters were written by the agency's device center.

Medical Device Regulation

Warning Letter Close-Outs – August 2017

US FDA released six device-related close-out letters in August.

Medical Device Device Warning Letters

Warning Letter Roundup & Recap – Aug. 29, 2017

US FDA did not release any device-related warning letters the week of Aug. 29.

Device Warning Letters Regulation

Warning Letter Roundup & Recap – Aug. 22, 2017

US FDA did not release any device-related warning letters the week of Aug. 22.

Device Warning Letters Regulation

Warning Letter Roundup & Recap – Aug. 15, 2017

US FDA did not release any device-related warning letters the week of Aug. 15.

Medical Device Device Warning Letters
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