FDA Inspection 1270287 — Altru Health Systems
The FDA completed an inspection of Altru Health Systems on May 20, 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). 1 citation was issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- May 20, 2025
- Fiscal Year
- 2025
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Grand Forks, ND (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 4425 | 21 CFR 606.60(a) | Equipment observed, standardized, calibrated |