The Food & Drug Administration sent a warning letter to Philips Healthcare warning it of violations found during spot inspections of facilities including a plant in Andover, Mass.
The letter, sent to Philips Healthcare CEO Steve Rusckowski Oct. 9 and posted on the FDA’s website Oct. 20, said spot inspections between January and March this year found that patient monitoring cardiac care products and ultrasound transducers made at the Andover facility and elsewhere were “adulterated,” at least according to federal manufacturing standards.
That means the plants lacked adequate procedures for dealing with complaints within 90 days; according to the letter, several complaints filed in August 2007 concerning automated external defibrillators were not dealt with until January of this year.
The letter, signed by the FDA’s New England district director John Marzilli, said Philips’ response “appears to be adequate” but that further inspections are required to fully settle the issue.
Philips spokesman Steve Kelly told MassDevice in an email that the issues raised in the letter are not related to Philips’ voluntary recall of about 5,400 of its HeartStart FR2+ automated external defibrillators.
Noting that the FDA letter indicated that Philips adequately addressed all of the violations listed in the letter, Kelly wrote that the company will send a response to the agency.
“Philips has been cooperative and responsive to all of FDA’s requests, from the beginning of the inspection onward, providing detailed responses and offering documents to the FDA during and after the inspection,” he wrote. “Philips executives have also offered to meet with the FDA to resolve any remaining questions the agency may have.”
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