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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

 
• By Shawn M. Schmitt

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...

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