FDA Inspection 1257486 — Jackson Memorial Hospital Transfusion Medicine Services
The FDA completed an inspection of Jackson Memorial Hospital Transfusion Medicine Services on December 17, 2024 in Miami, FL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- December 17, 2024
- Fiscal Year
- 2025
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Miami, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 154 | 21 CFR 606.160(a)(1) | Concurrent documentation |
| 4425 | 21 CFR 606.60(a) | Equipment observed, standardized, calibrated |