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

Source: https://www.keypedia.com/records/483/jackson-memorial-hospital-transfusion-medicine-services/e832ff3f-8cad-43bb-a45f-55428fe7354b

> FDA 483 for Jackson Memorial Hospital Transfusion Medicine Services on December 17, 2024. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Jackson Memorial Hospital Transfusion Medicine Services
- Inspection Date: 2024-12-17
- Product Type: biologics
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: 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.

## Related Documents

- [483 - 2024-12-17](https://www.keypedia.com/records/483/jackson-memorial-hospital-transfusion-medicine-services/fd4a60fd-7702-43b9-9f6d-e94602be01ed)

## Related Officers

- [Sergio E. Delgado](https://www.keypedia.com/people/sergio-e-delgado/5edfee62-05aa-44aa-9161-def8f31d3ea2)

Company: https://www.keypedia.com/companies/jackson-memorial-hospital-transfusion-medicine-services/fa52fec0-7c70-4768-9a96-d811791f1ec6

Office: https://www.keypedia.com/offices/office-of-medical-device-and-radiological-health-division-ii/ae9bd439-479a-420d-9dd8-9fe1fc0863d6