FDA 483 - Jackson Memorial Hospital Transfusion Medicine Services - December 17, 2024
Discuss this record with AI
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.
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.
- Inspection Date
- December 17, 2024
- Product Type
- Biologics
ID · e832ff3f-8cad-43bb-a45f-55428fe7354b