FDA Inspection 894426 — Bighorn Botanicals Inc
The FDA completed an inspection of Bighorn Botanicals Inc on Aug 11, 2014 in Noxon, MT. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 8 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Aug 11, 2014
- Fiscal Year
- 2014
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Noxon, MT (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15391 | 21 CFR 111.10(b)(3) | Hand washing |
| 15409 | 21 CFR 111.14(b)(1) | Personnel - records - written procedures |
| 15532 | 21 CFR 111.255(b) | Batch record - complete |
| 15745 | 21 CFR 111.210(h)(1) | Instructions; specifications; packaged, labeled |
| 15762 | 21 CFR 111.205(a) | Master manufacturing record - each batch |
| 15878 | 21 CFR 111.75(e) | Product - visually examine, identified |
| 15954 | 21 CFR 111.113(a)(2) | Quality control master manufacturing record; material review, disposition |
| 16072 | 21 CFR 111.35(b)(3) | Instruments, controls; calibrate date, reference std, method |