FDA Inspection 1214368 — Veterans Administration Hospital Blood Bank
The FDA completed an inspection of Veterans Administration Hospital Blood Bank on August 9, 2023 in Fort Harrison, MT. 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
- August 9, 2023
- Fiscal Year
- 2023
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Fort Harrison, MT (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 57 | 21 CFR 606.60(a) | Maintain and clean equipment |
| 94 | 21 CFR 606.100(b)(15) | Schedules and procedures for equipment & calibration |