Damning FDA-483: Philips Didn’t Investigate 222,000 Complaints Of Possible Degraded Foam In Breathing Devices

FDA investigator makes 8 observations during recent inspection of Philips Respironics facility

Royal Philips has been reeling from a June recall of millions of breathing machines, and now it’s been slapped by the US FDA with multiple observations after an on-site inspection. One observation says the company didn’t open formal investigations after receiving hundreds of thousands of complaints of particles and other contaminants when the recalled devices were used.

Philips corporation sign.
It's dark days for Philips • Source: Alamy

Things have gone from bad to worse for Royal Philips, which has been reeling from an early summer recall of millions of breathing machines because of degraded sound abatement foam. Now the company has been slapped with multiple risk management and quality systems observations after a recent on-site facility inspection by an investigator with the US Food and Drug Administration.

In one of the more damning observations made by investigator Katelyn Staub-Zamperini during the 26 August-9 November inspection, Philips apparently opened no formal investigations after it received hundreds of thousands...

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 Compliance

Get Ready For International Harmonization Before Approaching QMSR Deadline, Says Regulatory Expert

 

During MD&M East last week, regulatory consultant Darren Reeves reminded device manufacturers that the time to get ready to comply with the new Quality Management System Regulation is now.

FDA Draft Guidance Introduces Electric Submission For Q-Sub Process

 

The US FDA says its updated draft guidance represents one of several steps the agency is taking to develop electronic submission templates for the medical device industry. The document introduces stakeholders to currently available resources for supporting their pre-subs to the agency.

Industry Execs Talk Tariff Turbulence During MD&M East

 

During MD&M East in Manhattan last week, a panel of experts discussed how the Trump administration’s trade policy is affecting manufacturing and offered some ideas on what manufacturers can do to help mitigate the chaos.

FDA Halts Acceptance Of Chinese Lab Data Due To Accuracy Issues

 
• By 

The FDA has stopped accepting data from two Chinese labs due to accuracy issues. Mid-Link and SDWH have been flagged for potentially falsified results and other misconduct. This decision, which follows months of discussions and warnings, emphasizes the FDA's commitment to ensuring data integrity in medical device submissions.

More from Policy & Regulation

FDA Draft Guidance Introduces Electric Submission For Q-Sub Process

 

The US FDA says its updated draft guidance represents one of several steps the agency is taking to develop electronic submission templates for the medical device industry. The document introduces stakeholders to currently available resources for supporting their pre-subs to the agency.

Industry Execs Talk Tariff Turbulence During MD&M East

 

During MD&M East in Manhattan last week, a panel of experts discussed how the Trump administration’s trade policy is affecting manufacturing and offered some ideas on what manufacturers can do to help mitigate the chaos.

Commission’s Flora Giorgio Says Simplification And Safety Are Key In Evolving EU Regs

 

Predictability, proportionality, stability, harmonization and simplification offer the right way forward to address the challenging unintended effects of the EU medical device regulations, the European Commission’s head of devices tells the EU’s largest annual medtech conference.