FDA Inspection 1277111 — CLVM LLC
The FDA completed an inspection of CLVM LLC on August 1, 2025 in Wellington, CO. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 13 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 1, 2025
- Fiscal Year
- 2025
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Wellington, CO (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15863 | 21 CFR 111.75(a)(2)(ii)(B) | Component - certificate of analysis |
| 15869 | 21 CFR 111.75(c) | Specifications met - verify; finished batch |
| 15963 | 21 CFR 111.113(b)(2) | Quality control - reject; specification not met |
| 15986 | 21 CFR 111.123(b)(2) | Quality control - batch, product specifications |
| 22812 | 21 CFR 111.453 | Written procedures - follow; holding and distribution |
| 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 |
| 22890 | 21 CFR 111.260 | Batch record - required information |
| 22891 | 21 CFR 111.303 | Written procedures - establish; laboratory |
| 3062 | 21 CFR 114.10 | Personnel |
| 3080 | 21 CFR 114.83 | Scheduled process establishment |
| 4464 | 21 CFR 108.25(c)(1) | Registration |