1. Medtech Insight
  2. >>Policy & Regulation
  3. >>Regulation

Zimmer Biomet Inspection Finds Extensive GMP Woes

 
• By Elizabeth Orr

The document cites a range of issues that could tie to product safety, such as water and air quality, and maintenance of a sterile work environment. But the company says it is working with US FDA on its remediation plan and states that no known product safety issues are linked to the observations.

A 58-page, 14-observation FDA Form 483 issued after a recent US FDA inspection of Zimmer Biomet Holdings Inc. ’s Warsaw, Ind., plant is likely to lead to a warning letter and ongoing remediation efforts, one analysis states.

The firm issued a statement Dec. 14 acknowledging receiving the FDA-483 form. Analysts at Wells Fargo Securities obtained the form...

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
Start Free Trial

Already a subscriber?

More from Regulation

Environmental Group Questions FDA’s Stance On PFAS In Medical Devices

 
• By Brian Bossetta

The US FDA says PFAS used in medical devices are safe and that there’s no reason to restrict them in device production. An environmental group finds the agency’s assertion questionable.

EU4Health Boost For Orphan Devices And SMEs

 
• By Ashley Yeo

EU4Health, the main funding instrument for EU health initiatives, has put renewed emphasis on orphan devices in its 2025 work program, published in July.

PathAI Talks PCCPs: ‘Accelerated Software Updates, Saves Time And Money’

 
• By Natasha Barrow

The US FDA has authorized around 107 devices with Predetermined Change Control Plans in place, with PathAI's AISight Dx digital pathology image management system one of the latest. Medtech Insight talks to Eric Walk, chief medical officer, to find out about the process and its benefits.

Scores Of Companies On Board With Medicare Data Interoperability And Digital Health Initiative

 
• By Brian Bossetta

The Centers for Medicare and Medicaid Services has launched a new program the agency says will allow patients easier access to their health data. More than 60 companies have already signed on.

More from Policy & Regulation

FTC Blocks Edwards Lifesciences’ Merger With JenaValve

 
• By Elizabeth Orr

The FTC is suing to block Edwards Lifesciences' purchase of JenaValve, citing concerns that it would reduce competition and innovation in the heart valve market and negatively impact patient access to vital treatments for aortic regurgitation. Edwards disagrees with the decision.

Swiss Medtech To Battle ‘Arbitrary’ 39% US Tariff

 
• By Ashley Yeo

In return for building a successful US export business, Switzerland has been handed a 39% tariff effective immediately by the Trump administration. Diplomatic channels have been reopened to undo the tariff. Meanwhile, the medtech industry is looking to develop OUS markets for Swiss exporters.

Injuries And Deaths Linked To Boston Scientific Cardiac Devices. Company Responds

 
• By Brian Bossetta

The US FDA issued a pair of early alerts on Wednesday warning customers about serious adverse events associated with two Boston Scientific cardiac devices. Both alerts include numerous reports of injuries and deaths and are part of the FDA’s ongoing pilot to enhance its recall process.