FDA Inspection 1195118 — Source-Omega LLC
The FDA completed an inspection of Source-Omega LLC on January 19, 2023 in South Lebanon, OH. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 7 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- January 19, 2023
- Fiscal Year
- 2023
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- South Lebanon, OH (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15531 | 21 CFR 111.255(a) | Batch record - every batch |
| 15641 | 21 CFR 111.453 | Written procedures - holding |
| 15763 | 21 CFR 111.205(a) | Master manufacturing record - unique formulation |
| 15790 | 21 CFR 111.403 | Written procedures - labeling operations |
| 15840 | 21 CFR 111.70(e) | Specifications - contamination limits |
| 15927 | 21 CFR 111.103 | Written procedures - quality control operations |
| 15939 | 21 CFR 111.105(g) | Quality control - reserve samples |