SSM-SLUH, Inc. – FDA 483, Apr 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.
ID · 232afcd2-c3f9-44c9-8a27-20c582ee0ae7
Full citation text and observation details available on the Dashboard.
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.