FDA Inspection 795622 — Scilabs Pharmaceuticals
The FDA completed an inspection of Scilabs Pharmaceuticals on August 14, 2012 in Irvine, 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: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- August 14, 2012
- Fiscal Year
- 2012
- Product Type
- Food/Cosmetics
- Project Area
- Foodborne Biological Hazards
- Location
- Irvine, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15404 | 21 CFR 111.12(c) | Personnel - education, training, experience |
| 15437 | 21 CFR 111.15(a)(1) | Grounds - equipment, litter, weeds |
| 15444 | 21 CFR 111.15(c)(1) | Cleaning compounds |
| 15456 | 21 CFR 111.20(b) | Physical plant - space; equipment, materials |
| 15532 | 21 CFR 111.255(b) | Batch record - complete |
| 15736 | 21 CFR 111.353 | Manufacturing operations - written procedures |
| 15858 | 21 CFR 111.75(a)(1)(i) | Component - verify identity, dietary ingredient |
| 15860 | 21 CFR 111.75(a)(2) | Component - confirm identity; specifications met |
| 15869 | 21 CFR 111.75(c) | Specifications met - verify; finished batch |
| 15927 | 21 CFR 111.103 | Written procedures - quality control operations |