Royal Philips

February 23, 2024 Dear Mr. Jakobs:

During an inspection of your firm's manufacturing facility located in Suzhou, China on October 23, 2023, through October 26, 2023, investigators from the United States Food and Drug Administration (FDA) determined that your firm manufactures Computed Tomography (CT) and ultrasonography systems. Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321(h), these products are devices because they are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or to affect the structure or function of the body.

This inspection revealed that these devices are adulterated within the meaning of section 501(h) of the Act, 21 U.S.C. § 351(h), in that the methods used in, or the facilities or controls used for, their manufacture, packing, storage, or installation are not in conformity with the current good manufacturing practice requirements of the Quality System regulation found at Title 21, Code of Federal Regulations (CFR), Part 820. We received responses from Xin Li, Head of Quality, dated November 17, 2023, and December 18, 2023, concerning our investigator's observations noted on the Form FDA 483 (FDA 483), List of Inspectional Observations, which was issued to your firm. Any additional responses will be addressed in conjunction with your response to this letter. We address these responses below, in relation to each of the noted violations. These violations include but are not limited to the following:

1. Failure to adequately define the type and extent of control to be exercised over the product, services, suppliers, contractors, and consultants, based on the evaluation results, as required by 21 CFR 820.50(a)(2). Specifically, your firm failed to ensure validation of the injection molding process used by your supplier of the custom-manufactured Philips Incisive CT Patient Interface Monitor (PIM) data cable. After 64 complaints of cable connection issues were received by your firm, the cable was redesigned (Design CR # D000865625) and a field correction was conducted ((C & R) 2022-PD-CTAMI-110). The cable connection failure led to ECG gating signal loss/error, which could cause a potential rescan and delay in diagnosis.

We reviewed your firm's responses dated November 17, 2023, and December 18, 2023, and conclude that they are not adequate. Your firm states that you placed a product hold on the PIM data cable to prevent its distribution. Your firm's responses state you requalified the supplier to perform process validation in accordance with company requirements, amending the quality agreement. The responses include documentation of a newly completed validation of the PIM cable injection molding process. Your firm's responses state that you are enhancing the Advanced Product Quality Plan process (16.2.19.1) to provide additional instruction on process validation requirements associated with processes where verification is not sufficient. Your firm's responses also include a retrospective review protocol defining the requirements and process for evaluating purchased parts provided by suppliers to support currently marketed products (for only parts released from July 1, 2021, to August 31, 2022). However, this retrospective analysis is limited to parts manufactured during a 14-month period and does not cover all relevant manufacturing processes (both at Philips facilities and at suppliers) to evaluate whether they have been adequately validated. Your firm's responses do not include documentation of training of employees on the revised protocol to prevent recurrence of this issue.

Our inspection also revealed that your firm's devices are misbranded under section 502(t)(2) of the Act, 21 U.S.C. § 352(t)(2), in that your firm failed or refused to furnish material or information respecting the device that is required by or under section 519 of the Act, 21 U.S.C. § 360i, and 21 CFR Part 806 — Medical Device; Reports of Corrections and Removals. Significant violations include, but are not limited to, the following:

2. Failure to submit a written report of a correction or removal of a device to FDA, initiated to reduce a risk to health or to remedy a violation which may present a risk to health, as required by 21 CFR 806.10. Specifically, your firm failed to report to FDA field corrections conducted to reduce the following risks to health:

CT patient interface monitor cable connection failure leading to an ECG gating signal loss/error, which could cause a delay in diagnosis (2022-PD-CTAMI-110)

CT software defects resulting in reversed or upside-down images, which could cause misdiagnosis (2022-PD-CTAMI-103)

CT software defects resulting in image artifacts and incorrect image orientation, which could cause misdiagnosis (2022-PD-CTAMI-114)

We reviewed your firm's responses dated November 17, 2023, and December 18, 2023, and conclude that they are not adequate. Since the inspection, FDA has received 21 CFR Part 806 reports for the three field corrections identified, as well as an additional 19 reports for recalls of other Philips radiology devices. Your firm's response includes a retrospective review which states that the three identified unreported field corrections were the only recalls that required reporting; however, FDA has recently received additional retrospective 21 CFR Part 806 reports from Philips covering older recalls (e.g., Philips' recall of the Ingenia MR system due to days-long loss of system access following power outages). 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. Your firm's response states that your firm is further updating the document, "Manage product correction and removal", 16.2.10, to help further ensure correct reporting determinations are made; however, your firm has yet to provide documentation of employee training.

Other federal agencies may take your compliance with the FD&C Act and its implementation regulations into account when considering the award of federal contracts. Additionally, should FDA determine that you have Quality System regulation violations that are reasonably related to premarket approval applications for Class III devices, such devices will not be approved until the violations have been addressed.

Please notify this office in writing within fifteen business days from the date you receive this letter of the specific steps your firm has taken to address the noted violations, including an explanation of how your firm plans to prevent these violations, or similar violations, from occurring again. Include documentation of the corrections and/or corrective action (which must address systemic problems) that your firm has taken. If your firm's planned corrections and/or corrective actions will occur over time, please include a timetable for implementation of those activities. If corrections and/or corrective actions cannot be completed within fifteen business days, state the reason for the delay and the time within which these activities will be completed. Please provide a translation of documentation not in English to facilitate our review. We will notify you regarding the adequacy of your firm's responses and the need to re-inspect your firm's facility to verify that the appropriate corrections and/or corrective actions have been made. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration as part of your response.

Your firm's response should be sent via email to CDRHWarningLetterResponsesWda.hhs.gov. Refer to CMS case #676605 when replying. If you have any questions about the contents of this letter, please contact: Lu Jiang at lu.jiang@fda.hhs.gov or +1(240)402-5779.

Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your firm's facility. 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. Your firm should investigate and determine the causes of any violations and take prompt actions to address any violations and bring the products into compliance.