FDA Inspection 1250231 — Osmosis, LLC
The FDA completed an inspection of Osmosis, LLC on November 7, 2024 in Evergreen, CO. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 11 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- November 7, 2024
- Fiscal Year
- 2025
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Evergreen, CO (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15529 | 21 CFR 111.30(e) | Equipment - controls, intended use |
| 15932 | 21 CFR 111.105(a) | Quality control - processes, specifications, written procedures |
| 15963 | 21 CFR 111.113(b)(2) | Quality control - reject; specification not met |
| 22843 | 21 CFR 111.70(b) | Specifications - components |
| 22844 | 21 CFR 111.70(c)(1) | In-process specification |
| 22847 | 21 CFR 111.70(e) | Specifications - finished dietary supplement |
| 22854 | 21 CFR 111.83(b) | Reserve sample - container-closure system |
| 22860 | 21 CFR 111.103 | Written procedures - follow; quality control operations |
| 22888 | 21 CFR 111.210 | Master manufacturing record - record requirements |
| 22890 | 21 CFR 111.260 | Batch record - required information |
| 22912 | 21 CFR 111.560(a) | Product complaint - qualified person review & investigate |