FDA 483 - SSM-SLUH, Inc. - February 17, 2023

An FDA inspection of SSM-SLUH, Inc., a hospital blood bank in Saint Louis, MO, revealed significant deficiencies in quality control and adherence to standard operating procedures. The firm failed to maintain adequate validation records for automated processes and did not properly investigate unexplained discrepancies related to emergency blood releases. Additionally, employees did not consistently follow written procedures for blood component processing and storage, and equipment validation plans were found to be inadequate.