FDA Inspection 1024085 — Herbally Yours, Inc.
The FDA completed an inspection of Herbally Yours, Inc. on August 31, 2017 in Gilbert, AZ. 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 31, 2017
- Fiscal Year
- 2017
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Gilbert, AZ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1471 | 21 CFR 113.83 | Scheduled processes not established |
| 15761 | 21 CFR 111.205(b)(1) | Master manufacturing record - specifications; quality |
| 15868 | 21 CFR 111.75(b)(2) | Specifications met - deviation, unanticipated occurrence |
| 15940 | 21 CFR 111.105(h) | Quality control - production, process control |
| 3877 | 21 CFR 113.60(c) | Coding - required elements |
| 4514 | 21 CFR 108.35(c)(1) | Registration |
| 4515 | 21 CFR 108.35(c)(2) | Process filing |
| 4524 | 21 CFR 108.35(g) | Approved school |