FDA Inspection 743858 — Omega Nutrition U.S.A Inc
The FDA completed an inspection of Omega Nutrition U.S.A Inc on August 29, 2011 in Bellingham, WA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 8 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 29, 2011
- Fiscal Year
- 2011
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Bellingham, WA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15543 | 21 CFR 111.260(c) | Batch record - date, time; maintenance |
| 15558 | 21 CFR 111.260(k)(1) | Batch record - identifier; packaging |
| 15559 | 21 CFR 111.260(k)(1) | Batch record - identifier; labels |
| 15560 | 21 CFR 111.260(k)(2) | Batch record - label |
| 15747 | 21 CFR 111.210(g) | Packaging description, representative label |
| 15748 | 21 CFR 111.210(f) | Master manufacturing record theoretical and expected yield |
| 15762 | 21 CFR 111.205(a) | Master manufacturing record - each batch |
| 15763 | 21 CFR 111.205(a) | Master manufacturing record - unique formulation |