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

An FDA inspection of Jackson Memorial Hospital Transfusion Medicine Services in Miami, FL, revealed significant deficiencies in equipment maintenance and record-keeping. The facility failed to perform quality assurance reviews of equipment calibrations and temperature alarm checks, and lacked verification documentation for a new temperature monitoring system. Additionally, the firm did not maintain concurrent records for the relocation of blood product inventory, hindering traceability.