FDA Inspection 806464 — Custompax, Inc., dba Vitaganic
The FDA completed an inspection of Custompax, Inc., dba Vitaganic on November 6, 2012 in Fremont, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 8 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- November 6, 2012
- Fiscal Year
- 2013
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Fremont, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15492 | 21 CFR 111.25(a) | Procedures - calibrating instruments |
| 15533 | 21 CFR 111.255(c) | Batch record - follow master |
| 15761 | 21 CFR 111.205(b)(1) | Master manufacturing record - specifications; quality |
| 15801 | 21 CFR 111.560(b) | Quality control, review, approve; investigate, follow-up |
| 15834 | 21 CFR 111.70(c)(2) | Specifications identity, purity strength, composition |
| 15858 | 21 CFR 111.75(a)(1)(i) | Component - verify identity, dietary ingredient |
| 15869 | 21 CFR 111.75(c) | Specifications met - verify; finished batch |
| 15898 | 21 CFR 111.83(b)(1) | Reserve sample -container-closure system |