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Royal Philips received a warning letter for quality system regulation (QSR) violations across three ultrasound and medical device manufacturing facilities in Washington, Pennsylvania, and the Netherlands. FDA inspections conducted between January and March 2025 determined that devices including the EPIQ Elite Ultrasound system, ultrasound transducers, IntelliSpace Cardiovascular, and eCareManager were adulterated because manufacturing methods, facilities, and controls failed to comply with current good manufacturing practice (CGMP) requirements under 21 CFR Part 820. The violations were identified across Philips Ultrasound's Bothell and Reedsville facilities and Philips Medical Systems Nederland B.V., with the company providing multiple response submissions to FDA in February, March, and April 2025.