The U.S. Food and Drug Administration (FDA) has sent Philips Healthcare of North Andover, Mass, a warning that its manufacturing methods at an Ohio facility that produces CT and nuclear medicine systems do not conform with required current good manufacturing processes.
The FDA found 16 manufacturing processes violations during an inspection of the facility, which produces the Brilliance, Big Bore, iCT and the MX-16 slice families of CT systems and the Gemini, Gemini, LXL/TF, BrightView, JetStream and Precedence families of nuclear medicine systems.
Most of the violations relate to problems with documentation, training and following procedures. This includes issues with responding to defects that caused fire, shock and poor image quality that could lead to false negatives. (See the FDA Warning Letter.)
The FDA has asked Philips to hire an outside consultant to audit the facility and submit a written plan for how the company will correct all the violations and prevent similar problems from occurring in the future. If Philips fails to do so, it could face regulatory action, including seizure, injunction and fines.
A Philips spokesperson told the Wall Street Journal that the company is confident it can comply with the FDA's demands and that the warning letter has not lessened demand or held up the manufacturing and shipping of systems build at its Ohio facility.