FDA Issues Warning Letter to Royal Philips Over Quality System Violations at Three Manufacturing Facilities
Washington, D.C. – October 30, 2025 – The U.S. Food and Drug Administration (FDA) has issued a warning letter to Royal Philips NV, citing significant violations of quality system regulations at three of the company’s medical device manufacturing facilities. The letter, dated September 9, 2025, and publicly posted on the FDA’s website today, declares devices produced at these sites „adulterated“ under the Federal Food, Drug, and Cosmetic Act due to nonconformance with current good manufacturing practices (CGMP) outlined in 21 CFR Part 820. The violations could impact the safety and reliability of ultrasound systems and related medical software used in diagnostic and therapeutic procedures. The warning follows inspections conducted earlier this year at Philips Ultrasound, LLC in Bothell, Washington (January 13–31, 2025); Philips Ultrasound, LLC in Reedsville, Pennsylvania (January 23–March 13, 2025); and Philips Medical Systems Nederland B.V. in Eindhoven,…


