FDA 483 - Children's Hospital and Research Center at Oakland - March 20, 2025

The FDA inspected Children's Hospital and Research Center at Oakland's Hospital Transfusion Service, identifying two observations related to record-keeping practices. The inspection revealed failures in maintaining storage and distribution records, specifically concerning physician signatures for emergency blood product releases. Additionally, records were not concurrently maintained for all significant processing steps, as evidenced by a lack of temperature documentation for irradiated blood units.