FDA Inspection 1231195 — Osmosis, LLC
The FDA completed an inspection of Osmosis, LLC on March 21, 2024 in Evergreen, CO. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 6 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- March 21, 2024
- Fiscal Year
- 2024
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Evergreen, CO (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15453 | 21 CFR 111.16 | Written procedures - cleaning |
| 15546 | 21 CFR 111.260(f) | Batch record - yield |
| 15829 | 21 CFR 111.70(b)(1) | Specifications - component identity |
| 15839 | 21 CFR 111.70(e) | Specifications - identity, purity, strength, composition |
| 15858 | 21 CFR 111.75(a)(1)(i) | Component - verify identity, dietary ingredient |
| 15927 | 21 CFR 111.103 | Written procedures - quality control operations |