FDA Warning Letter Recap
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.
The US FDA released one close-out letter in October, resolving a 2021 COVID-related warning letter.
The US FDA released one close-out letter in September, resolving a warning issued to a California device firm in 2017.
Med Pen Concepts LLC was the only recipient of a device-related warning letter from the US Food and Drug Administration last month.
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.
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.
Two Massachusetts-based infusion pump manufacturers with the same founder and CEO received warning letters from the US FDA for similar violations.
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.
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.
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.
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.
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.
All set! This article has been sent to email@example.com.
All fields are required. For multiple recipients, separate email addresses with a semicolon.
Please Note: Only individuals with an active subscription will be able to access the full article. All other readers will be directed to the abstract and would need to subscribe.