483
Jackson Memorial Hospital Transfusion Medicine ServicesJackson Memorial Hospital Transfusion Medicine Services – FDA 483, Dec 17, 2024
Record Details
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
View Company Profile
ID · fd4a60fd-7702-43b9-9f6d-e94602be01ed
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.