FDA Warns Philips Respironics on Malfunction Reporting
Royal Philips's (NYSE:PHG) subsidiary Philips Respironics got another warning letter from the FDA for falling short on how it reports and addresses malfunctions.
The Nov. 17 warning letter flagged the Philips division for failing to report multiple malfunctions to the FDA within 30 days of becoming aware of the problem. Philips Respironics also failed to counter the possibility that the snafus could cause death or serious injury if they happened again, the watchdog agency said.
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The Nov. 17 warning letter flagged the Philips division for failing to report multiple malfunctions to the FDA within 30 days of becoming aware of the problem. Philips Respironics also failed to counter the possibility that the snafus could cause death or serious injury if they happened again, the watchdog agency said.
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