483
St. George Regional HospitalFDA 483 - St. George Regional Hospital - July 20, 2022
Record Details
An FDA inspection of St. George Regional Hospital's Blood Bank identified significant deficiencies in quality control and record-keeping. The firm failed to thoroughly investigate and document biological product deviations, including instances of incorrect blood product issuance. Additionally, the hospital did not maintain complete records for emergency transfusions, specifically lacking physician signatures and proper justification.
- Office
- Denver District Office
- Person
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ID · 8a0968a5-b7c9-46a9-a123-983e5840dd4a