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FDA Warning Letter Recap

Warning Letter Close-Outs – April 2022

The US FDA issued four close-out letters last month. Three resolved warning letters that had been issued to duodenoscope manufacturers about problems with Sec. 522 postmarket studies.

Warning Letters FDA

FDA Warning Letter Recap, April 2022

A maker of skin-care products was cited for premarket violations in the only device-related warning letter released by the US agency last month.

Warning Letters FDA

FDA Warning Letter Recap, March 2022: Quality Systems Run Amok

A handful of domestic and foreign manufacturers were dinged by the US FDA for problems with quality systems. The agency released five device-related warning letters last month.

Warning Letters FDA

Warning Letter Close-Outs – March 2022

The US Food and Drug Administration posted one device-related closeout letter in March, which went to hemodialysis product company Diasol.

Warning Letters FDA

Warning Letter Close-Outs – February 2022

The US Food and Drug Administration issued two close-out letters in February, with missives going to Invisi Smart Technologies and Indus Medicare.

Warning Letters FDA

Warning Letter Roundup & Recap – March 2022

No device-related warning letters were released by the US FDA last month.

Warning Letters FDA

Inspection-Challenged FDA Defies Odds By Issuing Most Quality-Related Warning Letters Since 2017

US FDA data shared with Medtech Insight show that the number of quality-related warning letters sent to device manufacturers in calendar year 2021 ticked up 33% from 2020. Last year’s enforcement missives were also the most handed out by the agency in four years.

Warning Letters FDA

Warning Letter Close-Outs: Update

The US FDA released only one device-related close-out letter so far this year.

FDA Enforcement

FDA Warning Letter Recap, January 2022: Combo Product Maker Faces Quality Systems Violations

The US agency released only one device-related warning letter last month.

Warning Letters FDA

Warning Letter Close-Outs – December 2021

The US FDA released only one device-related close-out letter last month.

Warning Letters FDA

FDA Warning Letter Recap, December 2021: Medtronic Feels The Heat

Quality systems and Medical Device Reporting violations were noted by US FDA investigators during an on-site inspection of Medtronic’s Northridge, CA, facility. A total of seven device-related warning letters were released by the agency last month.

Warning Letters FDA

Warning Letter Close-Outs – November 2021

The US FDA issued three device-related close-out letters in November, with missives going to marketers of power wheelchairs, face masks, and mask decontamination systems.

Warning Letters FDA
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