FDA 483 - Black Pearl Vision - April 11, 2024

An FDA inspection of Black Pearl Vision in Sarasota, FL, identified a significant issue regarding the firm's corrective and preventive action (CAPA) system. The firm failed to adequately document CAPA activities, specifically not performing or documenting reviews of open CAPAs according to their established procedures. This indicates a lapse in quality system management related to CAPA oversight.