483
Denver Health Medical CenterFDA 483 - Denver Health Medical Center - June 05, 2025
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An FDA inspection of Denver Health Medical Center's blood bank in Denver, CO, identified two significant observations. The firm failed to adequately validate a new computer system used for blood product management and patient testing, lacking proper documentation for its performance and approval. Additionally, deficiencies were noted in maintaining complete records for emergency blood transfusions, specifically regarding the documentation of physician signatures.
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ID · 7b31d8b9-da67-4c1d-b7cc-9afa16c917e6