FDA Inspection 1269751 — Altru Health System
The FDA completed an inspection of Altru Health System on May 16, 2025 in Grand Forks, ND. 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
- May 16, 2025
- Fiscal Year
- 2025
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Grand Forks, ND (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 18081 | 21 CFR 630.10(e)(1) | Medical Assessment Factors |
| 9225 | 21 CFR 606.171 | Biological product deviation report |