FDA Inspection 962352 — INI Botanicals Inc
The FDA completed an inspection of INI Botanicals Inc on March 3, 2016 in Lombard, IL. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 8 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- March 3, 2016
- Fiscal Year
- 2016
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Lombard, IL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15532 | 21 CFR 111.255(b) | Batch record - complete |
| 15736 | 21 CFR 111.353 | Manufacturing operations - written procedures |
| 15763 | 21 CFR 111.205(a) | Master manufacturing record - unique formulation |
| 15825 | 21 CFR 111.65 | Quality control - quality, dietary supplement |
| 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 |
| 15864 | 21 CFR 111.75(a)(2)(ii)(C) | Documentation - qualify supplier |