FDA Inspection 1003250 — Innovita, LLC
The FDA completed an inspection of Innovita, LLC on March 6, 2017 in Ogden, UT. 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
- March 6, 2017
- Fiscal Year
- 2017
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Ogden, UT (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15498 | 21 CFR 111.27(d) | Equipment - maintain, clean, sanitize |
| 15532 | 21 CFR 111.255(b) | Batch record - complete |
| 15761 | 21 CFR 111.205(b)(1) | Master manufacturing record - specifications; quality |
| 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 |
| 15869 | 21 CFR 111.75(c) | Specifications met - verify; finished batch |
| 16057 | 21 CFR 111.535(b)(1) | Records - returned dietary supplement: written procedures |