FDA 483 - Exactech, Inc. - March 10, 2017

Exactech, Inc. in Gainesville, FL, a medical device manufacturer, was cited for significant deficiencies in its quality system during an FDA inspection. The inspection revealed inadequate procedures for corrective and preventive actions, design validation, complaint handling, supplier quality management, risk analysis, and employee training. Furthermore, the firm failed to submit multiple Medical Device Reports (MDRs) to the FDA within the required 30-day timeframe, indicating serious issues with post-market surveillance and regulatory compliance.