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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.

FDA Recalls

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 Letters Regulation

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.

Warning Letters FDA

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.

FDA Recalls

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.

United States FDA

Warning Letter Roundup & Recap – June 2022

No medtech-related warning letters were released by the US FDA in June.

Warning Letters FDA

Warning Letter Roundup & Recap – May 2022

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

Warning Letters FDA

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 Letters Regulation

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
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