FDA Inspection 1003270 — Vicare International (USA) INC.
The FDA completed an inspection of Vicare International (USA) INC. on March 1, 2017 in Alhambra, 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
- March 1, 2017
- Fiscal Year
- 2017
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Alhambra, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15410 | 21 CFR 111.14(b)(2) | Personnel - records - training |
| 15454 | 21 CFR 111.16 | Written procedures - pest control |
| 15825 | 21 CFR 111.65 | Quality control - quality, dietary supplement |
| 15838 | 21 CFR 111.70(d) | Specifications - labels, packaging |
| 15839 | 21 CFR 111.70(e) | Specifications - identity, purity, strength, composition |
| 15869 | 21 CFR 111.75(c) | Specifications met - verify; finished batch |
| 15902 | 21 CFR 111.83(b)(4) | Reserve sample - twice the quantity |