FDA 483 - SSM-SLUH, Inc. - April 19, 2022

An FDA inspection of SSM-SLUH, Inc., a hospital blood bank in Saint Louis, MO, revealed significant deficiencies across multiple areas. The firm failed to maintain validation records for automated equipment, did not consistently follow procedures for ABO/Rh testing and specimen labeling, and lacked proper maintenance and calibration records for blood processing equipment. Additionally, documentation for emergency blood releases was incomplete, with missing physician and witness signatures.