The FDA issued a warning to Philips Medical Systems, in a letter dated April 1 and released April 22, about problems with manufacturing procedures for its CT and nuclear imaging systems, including failures to oversee proper device design and proper procedures to handle complaints.
Inspections conducted at Philips’ Cleveland facility, from July 24, 2007, through Sept. 27, 2007, and from Oct. 22, 2007, through Nov. 9, 2007, revealed that the devices were adulterated.
“Corrective actions have been taken and continue to be taken, and we have been working closely with the FDA ever since to address the remaining issues. We are confident that our response to the FDA fully addresses all of the remaining issues outlined in the warning letter,” Ian Race, manager, corporate communications, Philips Healthcare, told Health Imaging News.
“Our previous responses to the FDA adequately addressed 10 of the 14 issues noted in the letter, and the FDA has acknowledged that as of today, only four responses are still incomplete,” Race said.
Race said the remaining issues revolve around the documentation the company needs to provide to the FDA on procedures including complaint handling, staff training and production process changes. “These are processes very much in place and held to a high internal quality standard, and Philips Healthcare will supply the agency with the additional documents it has requested,” he said.
The inspections revealed violations which included, but were not limited to, the following:
- Failure to adequately establish and maintain procedures to analyze sources of quality data to identify existing and potential causes of nonconforming products or other quality problems, to investigate the cause of nonconformities and to identify corrective actions needed. For example, a total of 1,216 software defects that were imported into the CT defect database in December 2004 were still open at the time of inspection and were not assigned a priority rating.
- Failure to adequately establish and maintain procedures for validating the device design. For example, the final validation report for the Gemini GXL PET/CT noted an issue regarding "streak" artifacts at one of the clinical sites; however, there was no further documented evaluation of this artifact to include significance and potential risk prior to the finalization of the design validation and commercial distribution, the agency wrote.
The FDA also found that risk analysis for a device when software defects are identified as a potential hazard, was not routinely updated and evaluated. For example, for the eight "potential hazard" software defects identified in software version 2.2.5 of the Brilliance 40 system, there was “no evidence that the Risk Management File was reviewed and updated for any of these potential hazards.” The agency also found that the software validation testing for the Brilliance 16P/16 system software version 2.2.5 was incomplete since it did not include four "body" phantom and six "head" phantom tests.
The inspections also revealed that Philips’ CT systems and nuclear imaging systems are misbranded, in that Philips failed or refused to furnish material or information respecting the device related to the Medical Device Reporting (MDR) regulation.
For example, the company failed to submit MDRs to the FDA within 30 calendar days of receiving or otherwise becoming aware that one of its commercially distributed devices malfunctioned and would be likely to cause or contribute to a death or serious injury if the malfunction were to recur.
The agency also noted that failure to promptly correct the violations may result in regulatory action being initiated by the FDA “without further notice,” including seizure, injunction and/or civil money penalties. Philips had 15 working days from receipt of the letter to take corrective action and notify the agency of such action.
Race noted that the company has been cooperative and responsive to all of the FDA’s requests, from the beginning of the inspection onward, providing detailed responses and offering documents to the FDA during and after the inspection.
“Our executives have offered to meet with the FDA to resolve any remaining questions the agency may have, and we have also hired a consultant with more than 30 years in dealing with FDA matters to review and verify that our corrective actions were satisfactory to