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Warning Letter Roundup & Recap

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

Warning Letter Roundup & Recap – Jan. 1, 2019

No device-related warning letters were released by US FDA the week of Jan. 1.

Device Warning Letters FDA

Warning Letter Close-Outs – December 2018

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

Device Warning Letters FDA

Warning Letter Roundup & Recap – Dec. 25, 2018

No device-related warning letters were released by US FDA the week of Dec. 25.

Device Warning Letters FDA

Warning Letter Roundup & Recap – Dec. 18, 2018

No device-related warning letters were released by US FDA the week of Dec. 18.

Device Warning Letters FDA

Warning Letter Roundup & Recap – Dec. 11, 2018

No device-related warning letters were released by US FDA the week of Dec 11.
Medical Device Device Warning Letters

Warning Letter Roundup & Recap – Dec. 4, 2018

Manufacturer of the MiBo Thermoflo device for treating chronic dry eye was cited for quality systems and Medical Device Reporting violations in the only device-related warning letter released by US FDA this week.

Device Warning Letters FDA

Warning Letter Close-Outs – November 2018

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

Device Warning Letters FDA

Warning Letter Roundup & Recap – Nov. 27, 2018

No device-related warning letters were released by US FDA the week of Nov. 27.

Device Warning Letters FDA

Warning Letter Roundup & Recap – Nov. 20, 2018

A maker and contract sterilizer of surgical trays and kits was dinged by FDA for not having an employee responsible for overseeing day-to-day quality operations, among other quality systems violations. The warning letter to American Contract Systems was the only device-related missive released by the US agency this week.

Device Warning Letters FDA

Warning Letter Roundup & Recap – Nov. 13, 2018

The manufacturer of VascuLab devices used in vascular pathology was cited for quality systems and Medical Device Reporting violations in the only device-related warning letter released by US FDA this week.

Device Warning Letters FDA
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