FDA Inspection 1258323 — Eniva USA, Inc.
The FDA completed an inspection of Eniva USA, Inc. on January 13, 2025 in Plymouth, MN. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 11 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- January 13, 2025
- Fiscal Year
- 2025
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Plymouth, MN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15496 | 21 CFR 111.27(b) | Instruments - calibration |
| 15533 | 21 CFR 111.255(c) | Batch record - follow master |
| 15698 | 21 CFR 111.320(a) | Examination, testing; appropriate |
| 15702 | 21 CFR 111.320(b) | Examination, testing; scientifically valid |
| 15732 | 21 CFR 111.365(a) | Conditions, controls -protect; microorganisms, contamination |
| 15858 | 21 CFR 111.75(a)(1)(i) | Component - verify identity, dietary ingredient |
| 15953 | 21 CFR 111.113(a)(1) | Quality control production, process control; material review, disposition |
| 22843 | 21 CFR 111.70(b) | Specifications - components |
| 22847 | 21 CFR 111.70(e) | Specifications - finished dietary supplement |
| 22890 | 21 CFR 111.260 | Batch record - required information |
| 3080 | 21 CFR 114.83 | Scheduled process establishment |