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

 
• By Shawn M. Schmitt

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.

Man walking on a straight road towards a group of dangerous sharks.
• Source: Alamy

Royal Philips could be staring down the barrel of a forthcoming warning letter from the US Food and Drug Administration after a high-risk recall of breathing devices and unfavorable facility inspection results that, among other things, claim management knew about problems with the products for more than a year before the recall was launched.

So says Ballard Graham, an industry veteran who was a compliance VP at Abbott for 13 years following a 31-year stint at the FDA, where he was an investigator, branch...

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