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.
‘A Very Broad Search’: Philips Pushes Back On FDA Claim Of 222,000 Uninvestigated Complaints
US Regulatory Roundup, November 2021
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.
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