FDA 483 - SSM-SLUH, Inc. - April 19, 2022
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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.
ID · 232afcd2-c3f9-44c9-8a27-20c582ee0ae7