FDA 483 - Exactech, Inc. - September 26, 2023

An FDA inspection of Exactech, Inc. in Gainesville, FL, a manufacturer of medical devices, revealed significant deficiencies in its quality system. The firm failed to adequately establish and implement procedures for corrective and preventive actions, particularly regarding complaint data analysis and risk evaluation for polyethylene shoulder implants. Additionally, Exactech did not submit 288 Medical Device Reports within the required 30-day timeframe.