FDA Inspection 1079917 — Prolifix Nutrition, LLC
The FDA completed an inspection of Prolifix Nutrition, LLC on February 15, 2019 in Hurricane, UT. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 7 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- February 15, 2019
- Fiscal Year
- 2019
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Hurricane, UT (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15410 | 21 CFR 111.14(b)(2) | Personnel - records - training |
| 15532 | 21 CFR 111.255(b) | Batch record - complete |
| 15786 | 21 CFR 111.410(b) | Labels - issuance, use |
| 15825 | 21 CFR 111.65 | Quality control - quality, dietary supplement |
| 15839 | 21 CFR 111.70(e) | Specifications - identity, purity, strength, composition |
| 16070 | 21 CFR 111.35(b)(2) | Document-equipment date of use, maintain, clean, sanitize |
| 16071 | 21 CFR 111.35(b)(3) | Documentation - instruments, controls; calibrations |