The FDA sent Philips Healthcare of North Andover, Mass., a warning letter on June 7, noting that its manufacturing methods at its Cleveland facilities do not conform with required current good manufacturing processes.

The Cleveland facility manufactures 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.

An inspection of the facility from Aug. 25, 2010 to Dec. 3, 2010 revealed 16 violations, including:

• Failure to establish and maintain procedures for implementing corrective and preventive action such as incorrect scaling for infant scans on the Brilliance 64 CT. Although Philips has submitted planned revisions, these have not been approved or implemented.
• Failure to adequately implement and record changes in methods and procedures needed to correct and prevent identified quality problems.
• Failure to establish and maintain adequate procedures to verify the design of the device in order to ensure that design output meets the design input requirements specified.

The agency informed Philips that it should take "prompt action" to correct the violations and that failure to do so could result in regulatory action such as seizure, injunction or monetary penalties.

The FDA is requiring Philips to contract with an outside expert consultant for an audit and to submit initial certifications by December 11.

Philips issued a statement in response to the letter and referred to its commitment to continuous improvement of quality and compliance processes. The company claimed to be "cooperative and responsive to all of the FDA’s requests, from the beginning of the inspection onward, providing detailed responses and documents to the FDA during and after the inspection. In the warning letter, FDA acknowledged the steps that Philips has undertaken to address the FDA investigator’s observations made during the inspection; however, the agency also indicated that the adequacy of Philips’ responses cannot be determined at this time.”

Philips plans to submit a written response to the FDA’s Warning Letter by June 29, including additional quality system documentation and records required to address the warning letter items. The response will include several additional actions to further strengthen the company’s quality system and assure compliance with regulations, Philips indicated.

The company also noted that it does not expect any disruptions in shipments to result from issuance of the warning letter.

“We are taking significant actions to rectify the identified items and are applying all necessary resources in order to do so. We have raised the bar on our standards and made huge investments of our overall compliance program throughout the entire organization. We are confident in the steps we have taken in implementing new quality measures in the development of our products and program offerings,” Philips spokesperson Ian Race said in an interview.