FDA 483 - Jackson Memorial Hospital Transfusion Medicine Services - December 17, 2024
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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.
- Inspection Date
- December 17, 2024
- Product Type
- Biologics
- Office
- Florida District Office
- Person
ID · fd4a60fd-7702-43b9-9f6d-e94602be01ed