FDA Inspection 944321 — American Nutritional Corp., Inc
The FDA completed an inspection of American Nutritional Corp., Inc on October 9, 2015 in Las Vegas, NV. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 13 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- October 9, 2015
- Fiscal Year
- 2016
- Product Type
- Food/Cosmetics
- Project Area
- Food and Color Additives Petition Review
- Location
- Las Vegas, NV (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15443 | 21 CFR 111.15(b)(2) | Physical plant - repair |
| 15473 | 21 CFR 111.20(c)(7) | Physical plant - separate areas - holding |
| 15532 | 21 CFR 111.255(b) | Batch record - complete |
| 15547 | 21 CFR 111.260(g) | Batch record - results; monitoring |
| 15675 | 21 CFR 111.315(b) | Sampling plans; establish, follow |
| 15733 | 21 CFR 111.365 | Manufacturing operations - prevent contamination |
| 15759 | 21 CFR 111.205(b)(2) | Master manufacturing record - controls, procedures |
| 15760 | 21 CFR 111.205(b)(1) | Master manufacturing record-specifications; packaged, label |
| 15830 | 21 CFR 111.70(b)(2) | Specifications-component purity, strength, composition |
| 15838 | 21 CFR 111.70(d) | Specifications - labels, packaging |
| 15839 | 21 CFR 111.70(e) | Specifications - identity, purity, strength, composition |
| 15872 | 21 CFR 111.75(c)(3) | Specifications met identity,purity, strength, comp,; basis |
| 15922 | 21 CFR 111.95(b)(3) | Documentation - ensure specifications met |