FDA 483 - Jackson Memorial Hospital Transfusion Medicine Services - December 17, 2024

An FDA inspection of Jackson Memorial Hospital Transfusion Medicine Services in Miami, FL, identified two observations related to quality assurance and record-keeping. The firm failed to perform adequate QA reviews for equipment calibrations and temperature alarm checks, and lacked verification documentation for a new temperature monitoring system. Additionally, the facility did not maintain concurrent records for the relocation of blood product inventory between storage devices.