Philips Healthcare received a warning letter earlier this month from the U.S. Food and Drug Administration (FDA) for violating several procedural regulations at its Andover, MA, facility.
The scope of the FDA inspection covered all products manufactured by and facilities operated by Philips Healthcare, a Philips spokesperson told AuntMinnie.com. According to the spokesperson, the FDA stated in the letter that Philips' previous responses to the inspectional observations had adequately addressed all the violations listed in the warning letter.
The FDA will verify the vendor's corrective actions in a follow-up inspection, which has yet to be scheduled. Philips will also submit a response to the warning letter, and said it has been cooperative and responsive to all of the FDA's requests.
Phillips executives have also offered to meet with the FDA to resolve any remaining questions the agency may have, according to the spokesperson.
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