FDA Inspection 1294692 — American National Red Cross
The FDA completed an inspection of American National Red Cross on December 10, 2025 in Lehi, UT. 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 10, 2025
- Fiscal Year
- 2026
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Lehi, UT (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 18134 | 21 CFR 640.21(g) | Informed consent |
| 89 | 21 CFR 606.100(b)(10) | Controlling storage temperatures |