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.  

Warning Rubber Stamp

Check out Medtech Insight's US FDA Warning Letter Data Tracker here.

This chart lists device-related warning letters released by the US Food and Drug Administration in October 2022. If an inspection...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Medtech Insight for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from Durable Medical Equipment

More from Device Area

Innovative Wants Injunction Against J&J Subsidiary After $442M Antitrust Verdict

 
• By 

Innovative Healthcare is asking for a permanent injunction against Johnson & Johnson subsidiary Biosense Webster after winning a $442 million antitrust verdict. The injunction aims to prevent continued anticompetitive practices in the electrophysiology catheter market.

Philips Deals Itself A Strong Hand In POCUS Stakes

 
• By 

Point of care ultrasound technology that can be used by non-sonographers will plug gaps in workforce coverage and bring new critical care capabilities to the frontline of care, said Royal Philips.

Liquid Biopsy Startup Mursla Bio Launches AI Precision Medicine Platform

 

The new AI Precision Medicine platform supports the company’s flagship product, EvoLiver, which received US FDA breakthrough device designation in April.