Exactech Sarasota, Inc. – FDA 483, Jul 25, 2025

Exactech Sarasota, Inc. received a Form FDA-483 with seven observations detailing significant quality system deficiencies. The inspection revealed inadequate procedures across multiple areas, including process controls, corrective and preventive actions, nonconforming product handling, environmental monitoring, supplier management, training, and acceptance activities. These issues collectively indicate a broad failure to ensure device conformance to specifications and maintain a robust quality system.