FDA Inspection 972356 — Custompax, Inc., dba Vitaganic
The FDA completed an inspection of Custompax, Inc., dba Vitaganic on May 27, 2016 in Fremont, CA. 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
- May 27, 2016
- Fiscal Year
- 2016
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Fremont, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15737 | 21 CFR 111.210(h)(5) | Corrective action plans |
| 15744 | 21 CFR 111.210(h)(2) | Master manufacturing record - sampling, tests, examinations |
| 15800 | 21 CFR 111.560(a)(2) | Product complaint - quality control investigate |
| 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 |
| 15871 | 21 CFR 111.75(c)(2) | Specifications met - test, examinations; compliance |