FDA 483 - McLaren Flint - October 20, 2025

McLaren Flint, a medical device establishment in Flint, MI, was inspected regarding its Proton Therapy System. The inspection revealed significant deficiencies across multiple quality system areas, including inadequate design validation, verification, and change control, as well as failures in complaint handling, MDR reporting timelines, and corrective and preventive actions. These issues indicate a systemic breakdown in maintaining an effective quality system, potentially compromising device safety and effectiveness.