The FDA published a warning letter that it sent to Philips
(NYSE: PHG)
that outlines issues around imaging technology manufacturing practices.
During an inspection of a manufacturing facility in Suzhou, China, the FDA determined that the devices are “adultered.” The inspection took place from Oct. 23, 2023, through Oct. 26, 2023. Philips received the letter outlining violations in the manufacturing of the computed tomography (CT) systems on Feb. 23, 2024.
The devices are adultered in that the methods used in, or the facilities or controls used for their manufacture, storage or installation are not in conformity with current good manufacturing practices, the FDA said.
According to the FDA, Philips Head of Quality for the plant, Xin Li, responded to the inspection’s findings on Nov. 17, 2023, and Dec. 18, 2023.
This latest regulatory setback for Philips follows the long-running saga around its Respironics business and a CPAP recall.
Detailing the Philips violations
The letter outlined two violations. First, it cited a failure to adequately define the type and extent of control to be exercised over the product, services, suppliers, contractors, and consultants. The agency said Philips failed to ensure validation of the injection molding process used by the supplier of the Philips Incisive CT patient interface monitor (PIM) data cable.
Philips redesigned the cable and conducted a field correction after 64 complaints of connection issues. This connection failure led to ECG gating signal loss/error. That could potentially result in rescans and a delay in diagnosis. The FDA said the company’ response proved inadequate and found the devices to be misbranded.
The FDA found a second violation in that Philips failed to submit a written report of a correction or removal of a device to the agency. This would reduce a risk to health or remedy a violation that may present a risk to health. Specifically, the company failed to report to FDA field corrections conducted to reduce a handful of risks.
Risks included CT patient interface monitor cable connection failure as well as multiple software defects. One defect resulted in reversed or upside-down images, which could cause misdiagnosis. Another defect led to image artifacts and incorrect image orientation, which could cause misdiagnosis.
Again, the FDA deemed Philips’ responses to the alleged violations inadequate.
Company statement
A Philips spokesperson told MassDevice via email that the warning letter advised Philips to take additional actions on the violations listed by the FDA. Specifically, the FDA advised the company to extend the window of review of the reportability of issued field safety notices related to products produced in the China plant. The observations included no reports of patient harm.
The spokesperson said Philips intends to complete all necessary actions in a timely manner. It does not anticipate production or shipment disruptions, or a material financial impact. The Suzhou facility primarily supplies markets outside the U.S., according to the spokesperson.
Philips Chief Patient Safety and Quality Officer of Philips, teve C de Baca, 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.”
