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483
•St. George Regional Hospital•July 20, 2022

St. George Regional Hospital – FDA 483, Jul 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.

Company
St. George Regional Hospital
Inspection date
July 20, 2022
Product type
biologics
Office
Denver District Office
Person
  • Emily B. Camire
View Company Profile

ID · 8a0968a5-b7c9-46a9-a123-983e5840dd4a

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