FDA Inspection 1277235 — Extract Labs, Inc.
The FDA completed an inspection of Extract Labs, Inc. on August 1, 2025 in Lafayette, CO. 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
- August 1, 2025
- Fiscal Year
- 2025
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Lafayette, CO (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15512 | 21 CFR 111.27(d)(1) | Equipment - taken apart |
| 15532 | 21 CFR 111.255(b) | Batch record - complete |
| 15858 | 21 CFR 111.75(a)(1)(i) | Component - verify identity, dietary ingredient |
| 15861 | 21 CFR 111.75(a)(2)(ii)(A) | Component - qualify supplier |
| 15897 | 21 CFR 111.83(a) | Reserve sample - collect, hold |
| 15986 | 21 CFR 111.123(b)(2) | Quality control - batch, product specifications |
| 22843 | 21 CFR 111.70(b) | Specifications - components |
| 22884 | 21 CFR 111.205(a) | Master manufacturing record - prepared |
| 22890 | 21 CFR 111.260 | Batch record - required information |