FDA Inspection 1298552 — Focus Nutrition
The FDA completed an inspection of Focus Nutrition on January 15, 2026 in Orem, UT. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 16 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- January 15, 2026
- Fiscal Year
- 2026
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Orem, UT (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15531 | 21 CFR 111.255(a) | Batch record - every batch |
| 15532 | 21 CFR 111.255(b) | Batch record - complete |
| 15838 | 21 CFR 111.70(d) | Specifications - labels, packaging |
| 15843 | 21 CFR 111.70(g) | Specifications - finished packaging, labeling |
| 15971 | 21 CFR 111.120(a) | Quality control operations - receiving records |
| 18143 | 21 CFR 117.35(b)(1) | Cleaning and sanitizing substances - Safe and adequate |
| 18145 | 21 CFR 117.35(c) | Pest control |
| 19027 | 21 CFR 117.126(a)(1) | Food safety plan |
| 22811 | 21 CFR 111.453 | Written procedures - establish; holding and distribution |
| 22813 | 21 CFR 111.553 | Written procedures - establish; product complaint |
| 22815 | 21 CFR 111.8 | Written procedures - establish; personnel |
| 22834 | 21 CFR 111.25 | Equipment - establish written procedures |
| 22847 | 21 CFR 111.70(e) | Specifications - finished dietary supplement |
| 22859 | 21 CFR 111.103 | Written procedures - establish; quality control operations |
| 22884 | 21 CFR 111.205(a) | Master manufacturing record - prepared |
| 22908 | 21 CFR 111.503 | Written procedures - establish; returned dietary supplements |