FDA Inspection 1204398 — Saint Alphonsus Regional Medical Center
The FDA completed an inspection of Saint Alphonsus Regional Medical Center on May 4, 2023 in Boise, ID. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 2 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- May 4, 2023
- Fiscal Year
- 2023
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Boise, ID (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 149 | 21 CFR 606.151(e) | Procedures to expedite transfusions in emergencies |
| 9225 | 21 CFR 606.171 | Biological product deviation report |