FDA Inspection 1028597 — Anatox Incorporated
The FDA completed an inspection of Anatox Incorporated on October 13, 2017 in Richland, MO. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 8 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- October 13, 2017
- Fiscal Year
- 2018
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Richland, MO (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1287 | 21 CFR 110.20(a)(1) | Harborage areas |
| 15566 | 21 CFR 111.260(l)(3) | Batch record - approved, released, rejected; batch |
| 15754 | 21 CFR 111.210(a) | Master manufacturing record - dietary ingredients |
| 15761 | 21 CFR 111.205(b)(1) | Master manufacturing record - specifications; quality |
| 15825 | 21 CFR 111.65 | Quality control - quality, dietary supplement |
| 15829 | 21 CFR 111.70(b)(1) | Specifications - component identity |
| 15839 | 21 CFR 111.70(e) | Specifications - identity, purity, strength, composition |
| 15985 | 21 CFR 111.123(b)(1) | Quality control - components, identity specifications |