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FDA Warning Letter Recap

Warning Letter Roundup & Recap – October 2022

The US Food and Drug Administration published two warning letters last month, with one going to aesthetic device company Flawless Beauty and Skin and the other being sent to power chair manufacturer Forcemech International.  

Durable Medical Equipment Regulation

Warning Letter Close-Outs – October 2022

The US FDA released one close-out letter in October, resolving a 2021 COVID-related warning letter. 

Warning Letters Regulation

Warning Letter Close-Outs – September 2022

The US FDA released one close-out letter in September, resolving a warning issued to a California device firm in 2017.

Warning Letters Regulation

Warning Letter Roundup & Recap – September 2022

Med Pen Concepts LLC was the only recipient of a device-related warning letter from the US Food and Drug Administration last month.

Regulation FDA

Class-Action Suit Alleges Medtronic’s Rosy Forecast For MiniMed780G Misled Investors

The lawsuit says that Medtronic continued to predict that the new insulin pump would be FDA-approved shortly, even as other regulatory issues and recalls in the diabetes division made that less likely.

Legal Issues FDA

Warning Letter Roundup & Recap – August 2022

The US FDA handed warning letters to three manufacturers last month, including a COVID-19 test company as well as two infusion firms under the same ownership.

Warning Letters Regulation

Two Companies, One Owner; US FDA Sends Warning Letters To Same Address For Similar Issues

Two Massachusetts-based infusion pump manufacturers with the same founder and CEO received warning letters from the US FDA for similar violations.

FDA Warning Letters

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
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