FDA Warning Letter Recap
Warning Letters And Close-Outs – January/February 2024
The US Food and Drug Administration has released three warning letters and two close-outs so far this year, with missives citing problems with premarket authorizations, quality systems compliance and reporting.
FDA Rebukes Fresenius For Dragging Its Feet Over Toxins Risk
The US FDA issued a stern warning to Fresenius Medical Care over its slow approach to corrective actions over potentially harmful toxins emitted from its hemodialysis machines and accessories.
Warning Letters And Close-Outs – December 2023
The US Food and Drug Administration released three warning letters in December 2023, with missives going to device makers in Germany, Sweden and Argentina. No close-out letters were issued last month.
Warning Letters And Close-Outs – November 2023
The US Food and Drug Administration issued three device-related warning letters in November, which went to manufacturers in Texas, California and China. Additionally, a 2018 warning letter to South Korean firm Dexocowin has been resolved.
Warning Letters And Close-Outs – October 2023
The US Food and Drug Administration issued two device-related warning letters in October, one to Abiomed and one to WAVi Co.
Abiomed Letter Underscores Questions On FDA’s Clinical Decision Support Guidance
A warning letter from the US FDA to device manufacturer Abiomed highlights industry’s criticism that the agency’s final guidance on clinical decision support software is flawed and oversteps regulatory boundaries.
Warning Letters And Close-Outs – September 2023
It was a quiet month for warning letters at the FDA last month, with the agency issuing no new warning letters and closing out only one.
Warning Letters And Close-Outs – August 2023
The FDA issued warning letters to three US device firms last month, as well as closing out a 2021 letter to Invacare.
FDA Sends Warning Letter To Integra Following Recall Of Surgical Repair Products
After an inspection of its Boston facility, the US FDA issued a warning letter to Integra LifeSciences' subsidiary TEI Biosciences for distributing collagen-based medical devices that failed bacterial endotoxin tests and did not conform to good manufacturing practices.
July Warning Letter Prompts Pause In Dialysis Accessory Distribution
Following a recent warning letter from the US Food and Drug Administration, Outset Medical has stopped distribution of the TabloCart, an accessory to its Tablo Hemodialysis System.
Warning Letters And Close-Outs – July 2023
The US FDA issued warning letters to three companies last month and closed out seven letters sent to companies that sold unapproved thermometers during the COVID-19 pandemic.
Do Not Use Medical Devices From Texas Firm, FDA Warns
The US FDA is warning consumers to stay away from medical devices manufactured by a Texas firm because they have not been approved by the agency and their use may do more harm than good.
Second Warning To Utah Company For Promoting Device Outside Intended Use
The US Food and Drug Administration issued a warning letter to ZYTO Technologies for marketing its Hand Cradle Galvanic Skin Response device for purposes outside the scope of its authorized use.
FDA Sends Warning To Outset Medical Concerning Two Issues With Its Dialysis Device
The US Food and Drug Administration sent a warning letter to Outset Medical citing two concerns with the Tablo Hemodialysis System. Outset disclosed the letter in a recent filing with the US Securities and Exchange Commission.
Warning Letters And Close-Outs – June 2023
The US FDA issued warning letters to iRhythm, Steiner Biotech and Vitang technology last month, and also closed out two older warning letters.
Warning Letters And Close-Outs – May 2023
The US FDA issued one warning letter last month, and closed out warnings previously issued to Centurion Medical, Mentor Worldwide and Unimicro Medical Systems.
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