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Latest From Raptor Pharmaceutical Corp.

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

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.

Regulation Policy

Top 10 Medtech Themes For 2022 – And M&A Trends

The operating environment for medical technology companies becomes more complex, competitive and costly every year. There is no expectation that 2022 will buck that trend, even as the medtech sector prepares for a third year of working under conditions shaped by the COVID-19 pandemic.

Outlook 2022 Medical Device

After High-Risk Recall And Scathing Inspection Report, Is FDA Warning Letter Next For Philips?

Industry experts weigh in on what the US FDA’s enforcement options are following the company’s high-profile recall of millions of breathing devices and unfavorable facility inspection results.

Enforcement FDA

Damning FDA-483: Philips Didn’t Investigate 222,000 Complaints Of Possible Degraded Foam In Breathing Devices

Royal Philips has been reeling from a June recall of millions of breathing machines, and now it’s been slapped by the US FDA with multiple observations after an on-site inspection. One observation says the company didn’t open formal investigations after receiving hundreds of thousands of complaints of particles and other contaminants when the recalled devices were used.

Enforcement Safety
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