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‘A Very Broad Search’: Philips Pushes Back On FDA Claim Of 222,000 Uninvestigated Complaints

US Regulatory Roundup, November 2021

 
• By Shawn M. Schmitt

Royal Philips says a US FDA investigator wildly overcounted the number of complaints related to recalled breathing machines, disputing an inspection report that says the company failed to investigate hundreds of thousands of complaints. News of the agency’s inspection of a Philips facility – and what might come next for the firm – topped our list of most-read articles in November.

US Top Stories

The CEO of Royal Philips has pushed back on claims made in a US Food and Drug Administration facility inspection report that the company failed to investigate hundreds of thousands of complaints about recalled bi-level positive airway pressure (BiPAP), continuous positive airway pressure (CPAP), and other mechanical ventilator devices.

In one of the more damning observations made by FDA investigator Katelyn Staub-Zamperini during the 26 August-9 November inspection of Philips Respironics’ Murrysville, PA, plant, the company apparently opened no formal investigations after it received a tidal wave of complaints of particles and other contaminants when the devices were used

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