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Warning Letter Roundup & Recap

Warning Letter Roundup & Recap – June 20, 2017

US FDA did not release any device-related warning letters the week of June 20.

Device Warning Letters Medical Device

Warning Letter Roundup & Recap – June 13, 2017

A Georgia contact lens developer was the subject of the only device-related warning letter issued by US FDA this week.

Device Warning Letters Regulation

Warning Letter Roundup & Recap – June 6, 2017

US FDA did not release any device-related warning letters the week of June 6.

Device Warning Letters Medical Device

Warning Letter Close-Outs – May 2017

US FDA released four device-related close-out letters in May.

Device Warning Letters Medical Device

Warning Letter Roundup & Recap – May 30, 2017

US FDA did not release any device-related warning letters the week of May 30.

Device Warning Letters Medical Device

Warning Letter Roundup & Recap – May 23, 2017

US FDA did not release any device-related warning letters the week of May 23.

Medical Device Device Warning Letters

Warning Letter Roundup & Recap – May 16, 2017

Device-makers in Oregon, Connecticut and Illinois earned the three device-related warning letters issued by US FDA this week.

Device Warning Letters Regulation

Warning Letter Roundup & Recap – May 10, 2017

A Swiss device-maker received the only device-related warning letter issued this week.

Device Warning Letters Medical Device

Warning Letter Close-Outs – April 2017

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

Medical Device Device Warning Letters

Warning Letter Roundup & Recap – May 2, 2017

Manufacturers of ultrasound systems, vital sign monitors, and organ transplant devices were targeted by three device-related warning letters issued this week.

Device Warning Letters Medical Device

FDA Warning Letter Roundup & Recap – April 25, 2017

US FDA did not release any device-related warning letters the week of April 25.

Device Warning Letters Medical Device

Warning Letter Roundup & Recap – April 18, 2017

An Abbott plant manufacturing St. Jude Medical cardiac products was slapped with a warning for quality systems issues in the only warning letter released the week of April 18.

Device Warning Letters Regulation
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