FDA Inspection 1273248 — Prinova Nutrition
The FDA completed an inspection of Prinova Nutrition on August 22, 2025 in Spring Hill, TN. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 14 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 22, 2025
- Fiscal Year
- 2025
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Spring Hill, TN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15456 | 21 CFR 111.20(b) | Physical plant - space; equipment, materials |
| 15581 | 21 CFR 111.155(c)(3) | Quality control - components, approve, release |
| 15861 | 21 CFR 111.75(a)(2)(ii)(A) | Component - qualify supplier |
| 15882 | 21 CFR 111.75(h) | Tests, examinations - scientifically valid |
| 15932 | 21 CFR 111.105(a) | Quality control - processes, specifications, written procedures |
| 15999 | 21 CFR 111.127(h) | Quality control operations - packaging, labeling; approving, rejecting |
| 22818 | 21 CFR 111.10(b) | Hygienic practices |
| 22819 | 21 CFR 111.12 | Personnel - qualifications |
| 22835 | 21 CFR 111.25 | Equipment - follow written procedures |
| 22836 | 21 CFR 111.27(a) | Equipment - design - appropriate and suitable |
| 22843 | 21 CFR 111.70(b) | Specifications - components |
| 22888 | 21 CFR 111.210 | Master manufacturing record - record requirements |
| 22890 | 21 CFR 111.260 | Batch record - required information |
| 22897 | 21 CFR 111.325(b) | Make and keep records - laboratory operations |