‘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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