FDA Inspection 1178837 — Anatox Incorporated
The FDA completed an inspection of Anatox Incorporated on September 2, 2022 in Richland, MO. 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
- September 2, 2022
- Fiscal Year
- 2022
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Richland, MO (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15402 | 21 CFR 111.12 | Personnel - quality control personnel - qualified |
| 15492 | 21 CFR 111.25(a) | Procedures - calibrating instruments |
| 15532 | 21 CFR 111.255(b) | Batch record - complete |
| 15581 | 21 CFR 111.155(c)(3) | Quality control - components, approve, release |
| 15761 | 21 CFR 111.205(b)(1) | Master manufacturing record - specifications; quality |
| 15762 | 21 CFR 111.205(a) | Master manufacturing record - each batch |
| 15768 | 21 CFR 111.420(c) | Repackaged, relabeled - quality control: approve, rejects |
| 15829 | 21 CFR 111.70(b)(1) | Specifications - component identity |
| 15830 | 21 CFR 111.70(b)(2) | Specifications-component purity, strength, composition |
| 15831 | 21 CFR 111.70(b)(3) | Specifications - contamination limits |
| 15839 | 21 CFR 111.70(e) | Specifications - identity, purity, strength, composition |
| 15841 | 21 CFR 111.70(f) | Specifications - product received for packaging, labeling |
| 15885 | 21 CFR 111.77(a) | Specifications not met - reject, quality control |
| 15934 | 21 CFR 111.105(c) | Quality control - basis; in-process, component, specifications |