Medtech Insight is part of the Business Intelligence Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

Warning Letter Roundup & Recap

Warning Letter Roundup & Recap – March 19, 2019

Two makers of breast implants failed to comply with years-old FDA post-approval study orders, and TEI Biosciences Inc. – an Integra LifeSciences company – ran afoul of the US agency's Quality System Regulation in device-related warning letters released by FDA this week.

Device Warning Letters FDA

Warning Letter Roundup & Recap – March 12, 2019

No device-related warning letters were released by US FDA the week of March 12.

Device Warning Letters FDA

Warning Letter Roundup & Recap – March 5, 2019

No device-related warning letters were released by US FDA the week of March 5.

Device Warning Letters FDA

Warning Letter Roundup & Recap – Feb. 26, 2019

Intra-aortic balloon pump manufacturer Datascope was cited for quality systems violations, and maker of the Thermography Business Package for thermal imaging was cited for pre-market violations in the only device-related warning letters released by US FDA this week.

Device Warning Letters FDA

Warning Letter Roundup & Recap – Feb. 19, 2019

A Beverly Hills doctor was slapped with a US FDA warning letter for quality systems, Medical Device Reporting and pre-market issues related to a device used during breast augmentation procedures, and an Oyster Bay, NY, specification developer of the Better Bladder device was instructed by the agency to hire a consultant to help fix its quality systems issues. Two other missives were released this week – the first device-related warning letters posted online by FDA since early December 2018.

Device Warning Letters FDA

Warning Letter Roundup & Recap – Feb. 12, 2019

No device-related warning letters were released by US FDA the week of Feb. 12.

Device Warning Letters FDA

Warning Letter Roundup & Recap – Feb. 6, 2019

No device-related warning letters were released by US FDA the week of Feb. 6.

Device Warning Letters FDA

Warning Letter Close-Outs – January 2019

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

Device Warning Letters FDA

Warning Letter Roundup & Recap – Jan. 29, 2019

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

Device Warning Letters FDA

Warning Letter Roundup & Recap – Jan. 22, 2019

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

Device Warning Letters FDA

Warning Letter Roundup & Recap – Jan. 15, 2019

No device-related warning letters were released by US FDA the week of Jan. 15.

Device Warning Letters FDA

Warning Letter Roundup & Recap – Jan. 8, 2019

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

Device Warning Letters FDA
See All
UsernamePublicRestriction

Register