FDA 483 - Lexington Medical Center - October 30, 2024

An FDA inspection of Lexington Medical Center, a hospital blood bank in West Columbia, SC, identified two significant observations. The facility failed to maintain complete records for emergency transfusions, specifically lacking physician signatures for numerous blood and blood product units. Additionally, the firm did not consistently follow its written standard operating procedures for processing blood and blood components for allogeneic transfusion, particularly concerning quality control log documentation.