FDA Inspection 1160007 — Nutra Valley LLC
The FDA completed an inspection of Nutra Valley LLC on January 4, 2022 in Nashport, OH. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 9 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- January 4, 2022
- Fiscal Year
- 2022
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Nashport, OH (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15509 | 21 CFR 111.27(a)(6) | Instruments, controls - accurate, precise, maintained |
| 15532 | 21 CFR 111.255(b) | Batch record - complete |
| 15733 | 21 CFR 111.365 | Manufacturing operations - prevent contamination |
| 15770 | 21 CFR 111.420(a) | Repackaging, relabeling - quality control, approve |
| 15800 | 21 CFR 111.560(a)(2) | Product complaint - quality control investigate |
| 15830 | 21 CFR 111.70(b)(2) | Specifications-component purity, strength, composition |
| 15839 | 21 CFR 111.70(e) | Specifications - identity, purity, strength, composition |
| 15899 | 21 CFR 111.83(b)(1) | Reserve sample container-closure contamination,deterioration |
| 15932 | 21 CFR 111.105(a) | Quality control - processes, specifications, written procedures |