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Warning Letter Roundup & Recap

Warning Letter Roundup & Recap – 8 April 2020

Manufacturers of endoscopic equipment, biofeedback devices and thermometers were among those cited for regulatory violations in US FDA warning letters this week. A total of four device-related enforcement missives were released by the agency.

Device Warning Letters FDA

Warning Letter Close-Outs – March 2020

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

Device Warning Letters FDA

Warning Letter Roundup & Recap – 31 March 2020

No device-related warning letters were released by the US FDA the week of 31 March.

Device Warning Letters FDA

Warning Letter Roundup & Recap – 24 March 2020

No device-related warning letters were released by the US FDA the week of 24 March.

Device Warning Letters FDA

Warning Letter Roundup & Recap – 17 March 2020

No device-related warning letters were released by the US FDA the week of 17 March.

Device Warning Letters FDA

Warning Letter Roundup & Recap – 10 March 2020

No device-related warning letters were released by the US FDA the week of 10 March.

Device Warning Letters FDA

Warning Letter Roundup & Recap – 4 March 2020

Three device makers were issued warning letters after US FDA investigators discovered quality systems and Medical Device Reporting violations during facility inspections. A total of four enforcement missives were released by the agency this week.

Device Warning Letters FDA

Warning Letter Close-Outs – February 2020

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

Device Warning Letters FDA

Warning Letter Roundup & Recap – 27 February 2020

In separate warning letters, the US FDA says Biomedix (a maker of I.V. administration sets) and Unetixs Vascular (a maker of vascular diagnostic ultrasound systems) must hire outside consultants to review their quality systems after serious deficiencies were noted by agency investigators. A total of three enforcement missives were released by the FDA this week.

Device Warning Letters FDA

Warning Letter Roundup & Recap – 19 February 2020

No device-related warning letters were released by the US FDA the week of 19 February.

Device Warning Letters FDA

Warning Letter Roundup & Recap – 12 February 2020

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

Device Warning Letters FDA

Warning Letter Nosedive: FDA Makes History (Yet Again) By Sending Only 21 Of The Missives To Device Firms In 2019

A mere 21 quality-related warning letters were issued to device makers last year, the US agency tells Medtech Insight. It’s the third year in a row that the FDA has given out a record-low number of letters. In fact, 2019’s count of 21 represents a whopping 83% decrease from just five years ago, when 121 letters were sent to companies.

FDA Device Warning Letters
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