FDA Inspection 1263568 — WESTERN BOTANICALS FL, LLC
The FDA completed an inspection of WESTERN BOTANICALS FL, LLC on March 12, 2025 in Spanish Fork, UT. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 9 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 12, 2025
- Fiscal Year
- 2025
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Spanish Fork, UT (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15581 | 21 CFR 111.155(c)(3) | Quality control - components, approve, release |
| 15681 | 21 CFR 111.315(d) | Standard reference materials; criteria for selecting |
| 15886 | 21 CFR 111.77(b) | Specifications not met - identity; component, reject |
| 15932 | 21 CFR 111.105(a) | Quality control - processes, specifications, written procedures |
| 15940 | 21 CFR 111.105(h) | Quality control - production, process control |
| 22818 | 21 CFR 111.10(b) | Hygienic practices |
| 22843 | 21 CFR 111.70(b) | Specifications - components |
| 22847 | 21 CFR 111.70(e) | Specifications - finished dietary supplement |
| 22888 | 21 CFR 111.210 | Master manufacturing record - record requirements |