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Warning Letter Roundup & Recap

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

Warning Letter Roundup & Recap – April 11, 2017

US FDA did not release any device-related warning letters the week of April 11.

Device Warning Letters Medical Device

Warning Letter Roundup & Recap – April 4, 2017

US FDA did not release any device-related warning letters the week of April 4.

Device Warning Letters FDA

Warning Letter Closeouts – March 2017

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

Device Warning Letters Medical Device

Warning Letters Roundup & Recap – March 28, 2017

US FDA did not release any device-related warning letters the week of March 28.

Device Warning Letters Medical Device

Warning Letter Nosedive: US FDA Writes Fewest Quality-Related Missives Since 2002; Agency Isn't Sure Why

Only 57 quality-related warning letters were issued to device manufacturers in 2016, a 14-year-low that has left US FDA scratching its head as to why so few were sent to firms. "Our analyst team talked to both managers and staff alike within the device center, within ORA, and we could not identify a single factor or event to attribute the drop to," FDA compliance office official Sean Boyd said in an interview. Also: US inspections are down 2%, while foreign audits are up 16%; the top three quality system violations are revealed by FDA; an update on the number of close-out letters sent to firms; and more.

Device Warning Letters Quality Control

Warning Letter Roundup & Recap – March 21, 2017

No device-related warning letters were released by US FDA the week of March 21.

Device Warning Letters Medical Device

Warning Letter Roundup & Recap – March 14, 2017

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

Device Warning Letters Regulation

Warning Letter Roundup & Recap – March 7, 2017

A Los Angeles X-ray components manufacturer was cited for quality systems and Medical Device Reporting errors in the only device-related warning letter released by US FDA on March 7.

Device Warning Letters Medical Device

Warning Letter Close-Outs – February 2017

US FDA released eight device-related close-out letters in February.

Device Warning Letters Medical Device

Warning Letter Roundup & Recap – Feb. 28, 2017

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

Device Warning Letters Regulation
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