# FDA WARNING_LETTER - Royal Philips - October 26, 2023

Source: https://www.keypedia.com/records/warning_letter/royal-philips/790d15d9-0a92-43b9-833e-ded5cd36db00

> FDA WARNING_LETTER for Royal Philips on October 26, 2023. Product: Devices. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Royal Philips
- Inspection Date: 2023-10-26
- Product Type: Devices
- Office Name: Center for Devices and Radiological Health
- Summary: The FDA issued a Warning Letter to Philips Healthcare (Suzhou) Co., Ltd. following an inspection from October 23-26, 2023, at their Suzhou, China facility, which manufactures Computed Tomography (CT) and ultrasonography systems. The inspection found these devices adulterated under 21 U.S.C. § 351(h) due to non-conformity with Quality System (QS) regulation (21 CFR Part 820) and misbranded under 21 U.S.C. § 352(t)(2) for failing to report corrections and removals (21 CFR Part 806).

Key violations include:
1.  **Failure to adequately control suppliers (21 CFR 820.50(a)(2)):** The firm failed to ensure validation of the injection molding process by a supplier for the Philips Incisive CT Patient Interface Monitor (PIM) data cable. This led to 64 complaints, a cable redesign, and a field correction due to ECG gating signal loss/error, potentially causing rescans and diagnostic delays. The firm's responses were deemed inadequate as the retrospective review was limited in scope (July 2021-August 2022) and lacked documentation of employee training on revised protocols.
2.  **Failure to submit written reports of corrections or removals (21 CFR 80

## Related Documents

- [WARNING_LETTER - 2025-03-13](https://www.keypedia.com/records/warning_letter/royal-philips/3a3f39a4-f2ae-493b-90f3-f78114dd4b33)

## Related Officers

- [Office Director](https://www.keypedia.com/people/robert-a-ochs/27079757-05e8-4cf3-ac53-9b83b4b60624)
- [Kara Carter](https://www.keypedia.com/people/kara-carter/38bfabcb-b62d-41e8-84ef-5e051a1133fd)
- [Xin Li](https://www.keypedia.com/people/xin-li/8021b79a-7689-4826-8bf9-52d92a16060c)

Company: https://www.keypedia.com/companies/royal-philips/35480601-1b47-41b6-a926-f594c51f7ffa

Office: https://www.keypedia.com/offices/center-for-devices-and-radiological-health/9d89aff6-e435-4764-87be-f58c01aca7f7