FDA Inspection 1046118 — Source-Omega LLC
The FDA completed an inspection of Source-Omega LLC on March 27, 2018 in South Lebanon, OH. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 10 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 27, 2018
- Fiscal Year
- 2018
- 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 |
| 15659 | 21 CFR 111.475(b)(1) | Written procedures - holding; distributing |
| 15715 | 21 CFR 111.375(b) | Records - manufacturing operations; written procedures |
| 15762 | 21 CFR 111.205(a) | Master manufacturing record - each batch |
| 15790 | 21 CFR 111.403 | Written procedures - labeling operations |
| 15825 | 21 CFR 111.65 | Quality control - quality, dietary supplement |
| 15839 | 21 CFR 111.70(e) | Specifications - identity, purity, strength, composition |
| 15871 | 21 CFR 111.75(c)(2) | Specifications met - test, examinations; compliance |
| 15897 | 21 CFR 111.83(a) | Reserve sample - collect, hold |
| 16013 | 21 CFR 111.140(b)(1) | Records - quality control operations; responsibilities |