FDA WARNING_LETTER - Royal Philips - March 13, 2025

The FDA issued a Warning Letter to Royal Philips on September 9, 2025, following inspections of its medical device manufacturing facilities in Bothell, WA (Jan 13-31, 2025), Reedsville, PA (Jan 23-Mar 13, 2025), and Eindhoven, Netherlands (Jan 13-17, 2025). The inspections determined that medical devices, such as ultrasound systems and transducers, were produced under conditions that did not conform to current good manufacturing practice requirements, classifying them as adulterated under the Federal Food, Drug, and Cosmetic Act"s Quality System regulation (21 CFR Part 820). Key violations included the failure to adequately control outsourced activities and maintain proper complaint handling procedures. Specifically, Philips did not sufficiently evaluate or define control over its Philips Corporate Global Complaint Handling Operations (GCHO) contractor, which handles complaint and Medical Device Reporting, nor was GCHO initially on the approved suppliers list. Additionally, there was a lack of clear procedures and responsibility delineation for complaint reception, review, and evaluation. While Philips made some initial corrections, the FDA requires detailed plans demonstrating how Philips Ultrasound will confirm GCHO"s ongoing compliance with all specified requirements and adherence to revised complaint procedures.