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

After High-Risk Recall And Scathing Inspection Report, Is FDA Warning Letter Next For Philips?

 
• By Shawn M. Schmitt

Industry experts weigh in on what the US FDA’s enforcement options are following the company’s high-profile recall of millions of breathing devices and unfavorable facility inspection results.

Man walking on a straight road towards a group of dangerous sharks.
• Source: Alamy

Royal Philips could be staring down the barrel of a forthcoming warning letter from the US Food and Drug Administration after a high-risk recall of breathing devices and unfavorable facility inspection results that, among other things, claim management knew about problems with the products for more than a year before the recall was launched.

So says Ballard Graham, an industry veteran who was a compliance VP at Abbott for 13 years following a 31-year...

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 Compliance

More from Policy & Regulation

FDA Blocks Some Olympus Endoscopes From Entering US

 
• By Brian Bossetta

After multiple warning letters and safety communications, the US FDA has decided to block the import of certain endoscopes from Olympus. In total, the agency’s action pertains to 58 device models manufactured by the Japanese firm used in urinary, respiratory, abdominal and pelvic procedures.

UK Trails NHS 10-Year Plan With Launch Imminent

 
• By Ashley Yeo

Healthcare product industries await publication of the NHS 10-Year Plan, due out the coming days, which will focus on health generally not just the NHS, UK health secretary Wes Streeting said during a final prelaunch event on 24 June.

New EU Rules Limit Chinese Participation In Medtech Procurement

 
• By Amanda Maxwell

From June 30, new European Commission rules will attempt to redress an imbalance in medtech trade between the EU and the People’s Republic of China.