FDA Inspection 1200815 — InnoMark, Inc.
The FDA completed an inspection of InnoMark, Inc. on March 15, 2023 in Saint George, 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 15, 2023
- Fiscal Year
- 2023
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Saint George, UT (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12732 | 21 CFR 120.10(a) | Corrective action - predetermined plan |
| 15302 | 21 CFR 120.11(a)(2) | Calibration, testing - no records |
| 15532 | 21 CFR 111.255(b) | Batch record - complete |
| 15759 | 21 CFR 111.205(b)(2) | Master manufacturing record - controls, procedures |
| 15830 | 21 CFR 111.70(b)(2) | Specifications-component purity, strength, composition |
| 15854 | 21 CFR 111.73 | Specifications met - contamination limits |
| 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 |
| 9931 | 21 CFR 120.6(b) | Sanitation monitoring |
| 9947 | 21 CFR 120.11(b) | HACCP plan - not validated |