FDA 483 - Summit Industries Inc. - March 20, 2025

An FDA inspection of Summit Industries Inc., a medical device manufacturer, revealed significant deficiencies in their quality system. The firm failed to adequately establish and follow corrective and preventive action (CAPA) procedures, with numerous open CAPAs lacking timely completion of actions or root cause analyses. Additionally, production processes for devices like the Radiographic Table were not properly developed, lacking essential work instructions and quality procedures.