After a lengthy inspection of a Philips facility that manufactured several recalled breathing and ventilator devices, the US Food and Drug Administration delivered a pointed report to the company highlighting multiple risk management and quality systems issues. In response, Philips wrote to the FDA outlining steps it plans to take to fix the problems.
After recalling more than 2 million breathing devices in June 2021, Royal Philips found itself in royal trouble with the US Food and Drug Administration.
The class I recall of the company’s bi-level positive airway pressure (BiPAP), continuous positive airway pressure (CPAP), and other mechanical...