FDA Warning Letter Recap

Philips In Talks With DOJ Over Breathing Machine Recalls
After being subpoenaed by the US Department of Justice in April, Philips says it is negotiating with the department on a consent decree addressing numerous recalled breathing devices made by Philips Respironics.

Warning Letter Close-Outs – June-July 2022
The US FDA released four close-out letters in June and July, publicly resolving warning letters issued to manufacturers of wound dressings, artificial hips, IUDs and disposable electrodes.

Warning Letter Roundup & Recap – July 2022
A manufacturer and importer of COVID-19 tests was cited for distributing unauthorized devices as well as GMP violations in the only warning letter issued to a medtech company last month.

US FDA Slaps Another Class I Recall On Medtronic
The US FDA has identified a recall of Covidien catheters due to a hub defect as class I. The agency’s most serious designation is yet another for the company, which has recently recalled several devices.

Class I Recall For Smiths Medical Infusion Pumps
The US FDA designated an April recall of several syringe infusion pumps from Smiths Medical with its highest risk classification after multiple reports of serious injury, including one death.
Warning Letter Roundup & Recap – June 2022
No medtech-related warning letters were released by the US FDA in June.
Warning Letter Roundup & Recap – May 2022
No medtech-related warning letters were released by the US FDA last month.

Warning Letter Close-Outs – May 2022
The US FDA released three close-out letters last month, publicly resolving warning letters issued to companies based in Germany, Sweden, and Seattle, WA.

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.

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.

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 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.
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