Oct. 28 at 3:40 PM
Philips shares fell after the U.S. FDA issued a warning letter citing multiple violations at its medical device facilities in Bothell, Washington, Reedsville, Pennsylvania, and the Netherlands, based on inspections conducted from January to March 2025. The FDA identified deficiencies in quality control systems, complaint management, corrective actions, and reporting, including failures to properly assess complaints, implement corrective actions, and validate device designs. Specific concerns involved Philips ultrasound systems and transducers, including the EPIQ Elite system, with some transducers being refurbished and distributed beyond their three-year lifespan. Philips has 15 business days to respond with corrective measures, and failure to adequately address the issues could result in regulatory actions, including seizures, injunctions, and fines.
$PHG