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Philips hit by new FDA warning: recall policy at fault

Philips Medical Systems has been slapped with its second FDA warning letter in three months. The latest letter, received on October 16, takes the company to task for failing to inform the agency about 11 separate recalls involving a variety of products. All of the recalls were ranked as class II (medium-risk) recalls.

Philips Medical Systems has been slapped with its second FDA warning letter in three months. The latest letter, received on October 16, takes the company to task for failing to inform the agency about 11 separate recalls involving a variety of products. All of the recalls were ranked as class II (medium-risk) recalls.

Under FDA regulations, manufacturers and importers have 10 working days to notify the agency when they correct or remove a...

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