FDA 483 - Suncoast Communities Blood Bank, Inc. - July 01, 2022

An FDA inspection of Suncoast Communities Blood Bank, Inc. in Bradenton, FL, a community blood center, revealed a significant failure to thoroughly investigate unexplained discrepancies. This included issues with an insufficient number of product quality control samples tested and an inaccurate monitoring system for collected units and completed samples. These findings indicate a breakdown in the firm's quality system for ensuring product quality and data integrity.