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FDA Warning Letter Recap

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.

Regulation Warning Letters

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.

FDA Warning Letters

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.

FDA Warning Letters

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.

FDA Warning Letters

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.

FDA Regulation

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 Regulation

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.

FDA Regulation

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.

Regulation FDA

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.

Warning Letters Regulation

Facility Inspection Leads To FDA Warning For iRhythm

The US FDA issued a warning letter to iRhythm Technologies related to its Zio cardiac monitor system after an August 2022 inspection of the firm’s California facility. Wells Fargo predicts little impact on the company.

FDA Regulation

Warning Letters And Close-Outs – April 2023

The US FDA released four device-related warning letters in April, involving alleged regulatory violations from Abbott, North American Diagnostics, Medivance and Synovo. The agency also closed out a 2021 Medtronic warning letter.

Regulation Warning Letters

News We’re Watching: Potential Shockwave Sale, Medtronic Layoffs, Warning Letter For Abbott

This week, the US FDA announced the Class I recall of Fresenisu Kabi’s Ivenix Infusion System. Also: Successful trial results from Boston Scientific, Ancora partners with Egnite, and trade groups object to the Environmental Protective Agency’s proposed rules on ethylene oxide.

Commercial Regulation

Warning Letters And Close-Outs – March 2023

The US FDA released three device-related closeout letters in March, resolving past citations against Polymer Technology Systems, Skin Sheek and WHPM Inc. Additionally, a new warning letter was issued to Olympus Medical Systems.

Regulation Enforcement

FDA Slaps Olympus With Another Endoscope Warning

The US FDA recently rebuked Tokyo-based medical device firm Olympus for failing to adhere to good manufacturing practices for its endoscopes and for not investigating complaints related to the devices.

FDA Regulation

Feedback Sought On Proposals To Improve Australia’s Recall Processes

The deadline is nearing for comments on changes the Therapeutic Goods Administration has proposed making to its therapeutic products recall processes.

Recalls Australia

Warning Letters And Close-Outs – February 2023

The US FDA released three device-related closeout letters in February, resolving past citations against BioModeling Solutions, Sooil Development Co., and USA Medical LLC. No new warning letters were issued.

Regulation Medical Device
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