FDA Inspection 980581 — Avena Botanicals, LLC
The FDA completed an inspection of Avena Botanicals, LLC on June 28, 2016 in Rockport, ME. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- June 28, 2016
- Fiscal Year
- 2016
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Rockport, ME (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15828 | 21 CFR 111.70(a) | Specifications - manufacturing process |
| 15862 | 21 CFR 111.75(a)(2) | Appropriate tests, examinations; certificate of analysis |
| 15885 | 21 CFR 111.77(a) | Specifications not met - reject, quality control |
| 15890 | 21 CFR 111.80(a) | Components packaging, labels used |