Primary Children's HospitalApril 17, 2025

FDA 483 - Primary Children's Hospital - April 17, 2025

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Record Details

Primary Children's Hospital in Salt Lake City, UT, was inspected by the FDA from April 15-17, 2025. The inspection revealed a significant issue regarding the maintenance of records for emergency blood transfusions. Specifically, the hospital failed to obtain physician signatures for emergency-released blood products that were subsequently returned untransfused, indicating a lapse in critical record-keeping practices.

Company: Primary Children's Hospital
Inspection Date: April 17, 2025
Product Type: Biologics
Office: Denver District Office
People: Melissa S. Mcguinness
Emily B. Camire

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ID · c7ffda6a-4a0d-4e38-b318-c6a1bbef4ddc