FDA Inspection 897750 — Custompax, Inc., dba Vitaganic
The FDA completed an inspection of Custompax, Inc., dba Vitaganic on September 25, 2014 in Fremont, CA. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 10 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- September 25, 2014
- Fiscal Year
- 2014
- Product Type
- Drugs
- Project Area
- Unapproved and Misbranded Drugs
- Location
- Fremont, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15532 | 21 CFR 111.255(b) | Batch record - complete |
| 15737 | 21 CFR 111.210(h)(5) | Corrective action plans |
| 15754 | 21 CFR 111.210(a) | Master manufacturing record - dietary ingredients |
| 15829 | 21 CFR 111.70(b)(1) | Specifications - component identity |
| 15830 | 21 CFR 111.70(b)(2) | Specifications-component purity, strength, composition |
| 15831 | 21 CFR 111.70(b)(3) | Specifications - contamination limits |
| 15834 | 21 CFR 111.70(c)(2) | Specifications identity, purity strength, composition |
| 15838 | 21 CFR 111.70(d) | Specifications - labels, packaging |
| 15871 | 21 CFR 111.75(c)(2) | Specifications met - test, examinations; compliance |
| 15972 | 21 CFR 111.120(b) | Quality control operations - specifications; components, packaging, labels |