FDA Inspection 1241143 — Herbal Vitality, Inc
The FDA completed an inspection of Herbal Vitality, Inc on June 14, 2024 in Sedona, AZ. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 10 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- June 14, 2024
- Fiscal Year
- 2024
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Sedona, AZ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15532 | 21 CFR 111.255(b) | Batch record - complete |
| 15534 | 21 CFR 111.255(c) | Batch record - each step |
| 15737 | 21 CFR 111.210(h)(5) | Corrective action plans |
| 15745 | 21 CFR 111.210(h)(1) | Instructions; specifications; packaged, labeled |
| 15747 | 21 CFR 111.210(g) | Packaging description, representative label |
| 15748 | 21 CFR 111.210(f) | Master manufacturing record theoretical and expected yield |
| 15749 | 21 CFR 111.210(e) | Master manufacturing record - intentional overage |
| 15762 | 21 CFR 111.205(a) | Master manufacturing record - each batch |
| 15839 | 21 CFR 111.70(e) | Specifications - identity, purity, strength, composition |
| 15984 | 21 CFR 111.123(a)(8) | Quality control - finished batch, distribution |