FDA Warns Philips Over Quality Deficiencies at Three Factories

The U.S. Food and Drug Administration (FDA) has issued a warning letter to Philips, citing significant quality deficiencies at three of its manufacturing facilities. The affected sites are located in Bothell, Washington; Reedsville, Pennsylvania; and Eindhoven, Netherlands. Following inspections conducted in early 2025, the FDA determined that these facilities failed to meet required regulatory standards. The warning letter specifically addresses shortcomings in complaint handling, documentation, and the reporting of corrective actions. Products manufactured at these locations include ultrasound equipment, cardiac imaging software, and remote monitoring solutions.