FDA Inspection 748186 — Custompax, Inc., dba Vitaganic
The FDA completed an inspection of Custompax, Inc., dba Vitaganic on October 3, 2011 in Fremont, CA. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 9 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- October 3, 2011
- Fiscal Year
- 2012
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Fremont, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15544 | 21 CFR 111.260(d) | Batch record - component; unique identifier |
| 15554 | 21 CFR 111.260(j)(2)(ii) | Batch record - initials; verifying weight |
| 15556 | 21 CFR 111.260(j)(2)(iv) | Batch record - initials; verifying component |
| 15829 | 21 CFR 111.70(b)(1) | Specifications - component identity |
| 15853 | 21 CFR 111.73 | Specifications met - identity, purity, strength, composition |
| 15935 | 21 CFR 111.105(d) | Quality control - basis; tests, examinations |
| 15969 | 21 CFR 111.117(d) | Quality control operations - equipment functions |
| 15972 | 21 CFR 111.120(b) | Quality control operations - specifications; components, packaging, labels |
| 16067 | 21 CFR 111.35(b)(1)(ii) | Procedures - equipment; calibrating, inspecting, checking |