Exactech, Inc. – FDA 483, Aug 27, 2025

Exactech, Inc. in Gainesville, FL, received a Form FDA 483 with nine observations highlighting significant deficiencies in their quality system for orthopedic implants. The inspection revealed inadequate design verification and input documentation, unvalidated sterilization and vacuum sealing processes, and failures in corrective actions, supplier quality management, change control, and risk analysis. These findings indicate a need for comprehensive improvements to ensure product quality and patient safety.