FDA 483 - SpecialEyes, LLC - March 28, 2024

An FDA inspection of SpecialEyes, LLC in Sarasota, FL, revealed significant deficiencies in the firm's complaint handling and corrective and preventive action (CAPA) procedures. The company failed to process complaints uniformly and timely, adequately investigate them, or establish proper CAPA for identified issues, indicating a lack of robust quality system controls.