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.
