FDA Inspection 1276756 — Source-Omega LLC
The FDA completed an inspection of Source-Omega LLC on Jul 24, 2025 in South Lebanon, OH. 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). 7 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jul 24, 2025
- Fiscal Year
- 2025
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- South Lebanon, OH (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15869 | 21 CFR 111.75(c) | Specifications met - verify; finished batch |
| 22811 | 21 CFR 111.453 | Written procedures - establish; holding and distribution |
| 22827 | 21 CFR 111.16 | Written procedures - establish; cleaning |
| 22847 | 21 CFR 111.70(e) | Specifications - finished dietary supplement |
| 22884 | 21 CFR 111.205(a) | Master manufacturing record - prepared |
| 22888 | 21 CFR 111.210 | Master manufacturing record - record requirements |
| 22890 | 21 CFR 111.260 | Batch record - required information |