483
Denver Health Medical CenterDenver Health Medical Center – FDA 483, Jun 5, 2025
Record Details
An FDA inspection of Denver Health Medical Center's Blood Bank identified two significant observations. The firm failed to adequately validate a new computer system used for blood product management and patient testing. Additionally, the facility did not consistently maintain complete records for emergency transfusions, specifically regarding physician signatures.
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- Denver District Office
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ID · 52b0191a-31be-4df9-881e-3dca331ca692
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