FDA Inspection 1288160 — Steuart Nutrition, Inc.
The FDA completed an inspection of Steuart Nutrition, Inc. on October 22, 2025 in Le Roy, MN. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 5 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- October 22, 2025
- Fiscal Year
- 2026
- Product Type
- Food/Cosmetics
- Project Area
- Foodborne Biological Hazards
- Location
- Le Roy, MN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15698 | 21 CFR 111.320(a) | Examination, testing; appropriate |
| 15702 | 21 CFR 111.320(b) | Examination, testing; scientifically valid |
| 15865 | 21 CFR 111.75(a)(2)(ii)(D) | Re-confirm certificate of analysis |
| 22847 | 21 CFR 111.70(e) | Specifications - finished dietary supplement |
| 22884 | 21 CFR 111.205(a) | Master manufacturing record - prepared |