984585
ONE SOLUTION, LLC — FEI 2000012905
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 8, 2016
- Fiscal Year
- 2016
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Orem, UT (United States)
Citations
| ID | CFR | Description |
|---|
| 15532 | 21 CFR 111.255(b) | Batch record - complete |
| 15578 | 21 CFR 111.155(c) | Components - quarantine |
| 15723 | 21 CFR 111.365(i) | Metal, foreign material |
| 15762 | 21 CFR 111.205(a) | Master manufacturing record - each batch |
| 15783 | 21 CFR 111.410(d) | Manufacturing history |
| 15786 | 21 CFR 111.410(b) | Labels - issuance, use |
| 15797 | 21 CFR 111.553 | Written procedures - product complaint |
| 15825 | 21 CFR 111.65 | Quality control - quality, dietary supplement |
| 15829 | 21 CFR 111.70(b)(1) | Specifications - component identity |
| 15830 | 21 CFR 111.70(b)(2) | Specifications-component purity, strength, composition |
| 15839 | 21 CFR 111.70(e) | Specifications - identity, purity, strength, composition |
| 15858 | 21 CFR 111.75(a)(1)(i) | Component - verify identity, dietary ingredient |
| 15861 | 21 CFR 111.75(a)(2)(ii)(A) | Component - qualify supplier |
| 15867 | 21 CFR 111.75(b)(1) | Specifications met, in-process - quality finished batch |
| 15869 | 21 CFR 111.75(c) | Specifications met - verify; finished batch |
| 16057 | 21 CFR 111.535(b)(1) | Records - returned dietary supplement: written procedures |