FDA Inspection 1134649 — Warner Herb Co.
The FDA completed an inspection of Warner Herb Co. on January 12, 2021 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
- January 12, 2021
- Fiscal Year
- 2021
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Crossville, TN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15402 | 21 CFR 111.12 | Personnel - quality control personnel - qualified |
| 15545 | 21 CFR 111.260(e) | Batch record - component; identity, weight |
| 15641 | 21 CFR 111.453 | Written procedures - holding |
| 15736 | 21 CFR 111.353 | Manufacturing operations - written procedures |
| 15762 | 21 CFR 111.205(a) | Master manufacturing record - each batch |
| 15791 | 21 CFR 111.403 | Written procedures -packaging operations |
| 15829 | 21 CFR 111.70(b)(1) | Specifications - component identity |
| 15839 | 21 CFR 111.70(e) | Specifications - identity, purity, strength, composition |
| 15840 | 21 CFR 111.70(e) | Specifications - contamination limits |
| 15843 | 21 CFR 111.70(g) | Specifications - finished packaging, labeling |
| 15928 | 21 CFR 111.103 | Written procedure quality control operations material review |