Philips Healthcare has been given a warning letter from the U.S. Food and Drug Administration (FDA) for process issues related to manufacturing CT and nuclear medicine equipment at its Cleveland facility.
The warning letter said that Philips has failed to correct violations found in a 2010 inspection. The inspection had determined that methods used in, or the facilities or controls used for, the devices' manufacture, package, storage, or installation did not conform with the Current Good Manufacturing Practice (CGMP) requirements of the Code of Federal Regulations' Quality System regulation.
In a statement, Philips said it is committed to continuous improvement of its quality and compliance processes, and that it has been cooperative and responsive to all of the FDA's requests. In the letter, the FDA acknowledged the steps that Philips had taken to address the FDA investigator's observations during the inspection, but it also indicated that the adequacy of the company's responses cannot be determined at this time.
As a result, Philips said it will submit a written response by June 29, including additional quality documentation and records required to address the warning letter items. The response will also outline several additional actions Philips is implementing to further strengthen its quality system and ensure compliance with regulations, the company said.
As requested by the FDA, Philips has engaged an independent consultant to conduct a certified audit at the Cleveland facility. Philips said it expects that the FDA will conduct its own follow-up inspection of the facility after receiving the certified audit.
"Philips computed tomography and nuclear medicine equipment have a strong record in terms of safety and reliability, and we are committed to designing and producing these devices to the highest possible standards," the company said.
A Philips spokesperson told AuntMinnie.com said that the company is taking significant actions to rectify the identified items and is applying all necessary resources to do so.
"We have raised the bar on our standards and made huge investments of our overall compliance program throughout the entire organization," the spokesperson said. "We are confident in the steps we have taken in implementing new quality measures in the development of our products and program offerings."
Because the inspection focused on process issues and not specific safety issues with Philips products, the company does not anticipate any interruption to product shipments at this time, the spokesperson said.
