FDA Inspection 1266484 — Plant Manufacturing & Labs, LLC
The FDA completed an inspection of Plant Manufacturing & Labs, LLC on Apr 7, 2025 in American Fork, UT. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 8 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Apr 7, 2025
- Fiscal Year
- 2025
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- American Fork, UT (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15882 | 21 CFR 111.75(h) | Tests, examinations - scientifically valid |
| 15963 | 21 CFR 111.113(b)(2) | Quality control - reject; specification not met |
| 22843 | 21 CFR 111.70(b) | Specifications - components |
| 22847 | 21 CFR 111.70(e) | Specifications - finished dietary supplement |
| 22862 | 21 CFR 111.105(i) | Quality control - required operations |
| 22884 | 21 CFR 111.205(a) | Master manufacturing record - prepared |
| 22888 | 21 CFR 111.210 | Master manufacturing record - record requirements |
| 3080 | 21 CFR 114.83 | Scheduled process establishment |