FDA Inspection 1024968 — Bighorn Botanicals Inc
The FDA completed an inspection of Bighorn Botanicals Inc on September 12, 2017 in Noxon, MT. 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
- September 12, 2017
- Fiscal Year
- 2017
- Product Type
- Food/Cosmetics
- Project Area
- Colors and Cosmetics Technology
- Location
- Noxon, MT (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15600 | 21 CFR 111.160(d)(2) | Packaging, labels - unique identifier, disposition |
| 15828 | 21 CFR 111.70(a) | Specifications - manufacturing process |
| 15861 | 21 CFR 111.75(a)(2)(ii)(A) | Component - qualify supplier |
| 15954 | 21 CFR 111.113(a)(2) | Quality control master manufacturing record; material review, disposition |