The FDA sent Philips Healthcare a warning letter on Oct. 9 over a failed two-month inspection of its Andover, Mass., facility at the beginning of the year.
According to the agency, the inspection, which took place from Jan. 21 through March 10, revealed that devices, such as patient monitoring cardiac care products and ultrasound transducers, are “adulterated.” The methods used in, or the facilities or controls used for, the devices manufacture, packing, storage or installation do not conform with the Current Good Manufacturing Practice requirements of the Quality System regulation, the FDA said.
A Philips spokesperson said that the “scope of the inspection was not limited to those products that were designed and manufactured at the Andover facility but covered all products manufactured by, and facilities operated by Philips Healthcare.”
The violations included a failure to establish and maintain adequate procedures for receiving, reviewing and evaluating complaints by a formerly designated unit to ensure all complaints are processed in a uniform and timely manner.
Since the time of the violations, Philips has responded to the FDA on the Form FDA-483 in a manner that the agency said “appears to be adequate.” However, the FDA noted that a follow-up inspection will be required “to assure that corrections are adequate.” The Philips spokesperson noted that the follow-up inspection has not yet been scheduled.
Philips said it will submit a response to the FDA warning letter. Also, the Philips spokesperson said its executives have also offered to meet with the FDA to resolve any remaining questions the agency may have.