FDA Inspection 1090475 — Warner Herb Co.
The FDA completed an inspection of Warner Herb Co. on May 23, 2019 in Crossville, TN. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 14 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- May 23, 2019
- Fiscal Year
- 2019
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Crossville, TN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15404 | 21 CFR 111.12(c) | Personnel - education, training, experience |
| 15531 | 21 CFR 111.255(a) | Batch record - every batch |
| 15584 | 21 CFR 111.155(d)(1) | Components - identify lot produced |
| 15598 | 21 CFR 111.160(d)(1) | Packaging - identify |
| 15732 | 21 CFR 111.365(a) | Conditions, controls -protect; microorganisms, contamination |
| 15762 | 21 CFR 111.205(a) | Master manufacturing record - each batch |
| 15786 | 21 CFR 111.410(b) | Labels - issuance, use |
| 15825 | 21 CFR 111.65 | Quality control - quality, dietary supplement |
| 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 |
| 15861 | 21 CFR 111.75(a)(2)(ii)(A) | Component - qualify supplier |
| 15863 | 21 CFR 111.75(a)(2)(ii)(B) | Component - certificate of analysis |
| 15897 | 21 CFR 111.83(a) | Reserve sample - collect, hold |