FDA 483 - Exactech, Inc. - January 31, 2020

Exactech, Inc. in Gainesville, FL, a medical device manufacturer, was inspected by the FDA from January 27-31, 2020. The inspection revealed significant deficiencies across its quality system, particularly concerning corrective and preventive actions, design controls, supplier quality, nonconforming product control, and risk analysis. These issues indicate a systemic failure to adequately establish and follow procedures crucial for ensuring product quality and patient safety.