Philips has received a warning letter from the FDA concerning a facility in Suzhou, China, where ultrasound and CT manufacturing processes were found to be inadequate.

An FDA inspection, which took place in October 2023, highlighted significant noncompliance with the current good manufacturing practice requirements mandated under the Quality System regulation.

Notably, there was a critical failure in the validation of the injection molding process used by a supplier for the custom-manufactured Philips Incisive CT patient interface monitor (PIM) data cable. This cable had 64 reported complaints regarding connection issues, prompting a redesign and field correction to address potential rescan and diagnosis delays caused by ECG gating signal loss or error.

According to the letter, which was addressed to CEO Roy Jakobs and attributed to Robert Ochs, director of the FDA's office of Radiological Health/OIR/CDRH, the facility also failed to comply with the FDA’s requirements for reporting corrections and removals of medical devices. This includes failing to report field corrections associated with CT patient interface monitor cable connection failures and software defects that could result in misdiagnoses due to reversed images or incorrect image orientations.

Previous responses to the FDA, issued by Philips in November and December to address the inspection observations, were deemed "insufficient" and further corrective measures are being sought.

"While your firm's retrospective review covers the last two years, given the previously unreported recalls identified, a further lookback (beyond two years) is advised to ensure there are no additional field actions that require a report of correction and removal, per 21 CFR 806," the letter states.

The FDA requested Royal Philips provide detailed corrective actions within 15 business days from the receipt of the warning letter, along with a timetable for when these actions will be completed. The response should also include training documentation for employees on the revised protocols to prevent recurrence of these issues.

Philips issued the following statement to HCB News:

The warning letter advised Philips to take additional actions to address two of the inspectional observations. Specifically, the advice to extend the time window of the review of the reportability of issued field safety notices related to products produced in Suzhou and a review of all parts supplied to Suzhou. These observations did not involve reports of patient harm.

Philips is committed to completing the necessary actions in its Suzhou facility in a timely manner. At this point, the Philips Suzhou team does not anticipate production or shipment disruptions, or a material financial impact. The Suzhou facility primarily supplies markets outside the U.S.

Steve C. de Baca, chief patient safety and quality officer of Philips, said: “Patient safety and quality is Philips’ highest priority, and we have intensified our efforts to strengthen patient safety and quality management across the company. We will address any identified quality management issues thoroughly and transparently, ensuring proper coordination with the relevant global competent authorities and regulators. We are working closely with the FDA to address the matters raised in the warning letter and are committed to completing the necessary actions in a timely manner.”

Philips takes the FDA’s feedback very seriously. The Philips Suzhou team has provided a written response to the FDA outlining the actions to fully address the feedback and will continue to provide regular status reports to the FDA with the progress.

Failure to adequately resolve the issues, the letter warns, may affect the company's ability to secure FDA approvals for future products and could influence federal contract awards.

"Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your firm's facility," the FDA letter concludes. "It is your firm's responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violations noted in this letter and in the Inspectional Observations, FDA 483, issued at the close of the inspection may be symptomatic of serious problems in your firm's manufacturing and quality management systems."

Earlier this month, Philips entered a consent decree with the FDA and Department of Justice focusing on its Respironics business — the subject of a major recall over the past several years. Until the company meets the relevant requirements of the consent decree, it may not sell the CPAP and BiPap devices in the U.S.

The consent decree necessitates Philips Respironics implement a Recall Remediation Plan, collaboratively formulated with the FDA, to facilitate relief for affected patients through device replacement, rework, or partial refunds. This plan outlines specific remediation options and timelines, marking a first for a device company under such a decree to offer a remediation payment option.