FDA 483 - Illuminoss Medical Inc. - November 02, 2022

Illuminoss Medical Inc. in East Providence, RI, was inspected by the FDA from October 4 to November 2, 2022. The inspection revealed significant deficiencies in process validation, MDR reporting, corrective and preventive actions, design change control, and nonconforming product procedures. These issues indicate a lack of adequate quality system controls for their medical devices, including the Photodynamic Bone Stabilization Catheter System.