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Philips Implements Plan To Address FDA Concerns Following Harsh Inspection Report

 
• By Brian Bossetta

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.

Philips company logo sign. Philips s a Dutch technology company headquartered in Amsterdam with focused in the areas of electronics, health care and lighting. Copenhagen, Denmark, August 22, 2017. - Image
• Source: Shutterstock

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 ventilator devices triggered an agency inspection of the

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