FDA 483 - Philips Ultrasound, Inc - March 13, 2025

An FDA inspection of Philips Ultrasound, Inc. in Reedsville, PA, revealed significant deficiencies across its quality management system. The firm failed to adequately establish corrective and preventive actions, maintain complaint files, control finished devices, and define supplier controls. These issues indicate a systemic breakdown in quality management practices, potentially impacting product safety and effectiveness.