FDA WARNING_LETTER - Royal Philips - October 26, 2023

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