FDA Inspection 1267676 — Warner Herb Co.
The FDA completed an inspection of Warner Herb Co. on April 21, 2025 in Crossville, TN. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 11 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- April 21, 2025
- Fiscal Year
- 2025
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Crossville, TN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15434 | 21 CFR 111.15(d)(2) | Pest control measures |
| 15866 | 21 CFR 111.75(a)(2)(ii)(E) | Documentation - quality control, review, approve supplier |
| 22819 | 21 CFR 111.12 | Personnel - qualifications |
| 22823 | 21 CFR 111.15(b) | Physical plant - clean and sanitary |
| 22834 | 21 CFR 111.25 | Equipment - establish written procedures |
| 22842 | 21 CFR 111.60(a) | Production, in-process control system - design, quality |
| 22847 | 21 CFR 111.70(e) | Specifications - finished dietary supplement |
| 22859 | 21 CFR 111.103 | Written procedures - establish; quality control operations |
| 22882 | 21 CFR 111.180(b) | Documentation - components |
| 22884 | 21 CFR 111.205(a) | Master manufacturing record - prepared |
| 22902 | 21 CFR 111.410(b) | Label, packaging - issuance, use |