FDA Inspection 952161 — Sanozen Inc
The FDA completed an inspection of Sanozen Inc on November 23, 2015 in Vancouver, WA. 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
- November 23, 2015
- Fiscal Year
- 2016
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Vancouver, WA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15410 | 21 CFR 111.14(b)(2) | Personnel - records - training |
| 15442 | 21 CFR 111.15(b)(1) | Physical plant - clean and sanitary |
| 15496 | 21 CFR 111.27(b) | Instruments - calibration |
| 15522 | 21 CFR 111.27(d)(7) | Portable equipment - store |
| 15530 | 21 CFR 111.30(e) | Equipment - controls - QC |
| 15542 | 21 CFR 111.260(b) | Batch record - date, time; maintenance |
| 15706 | 21 CFR 111.325(a) | Laboratory operations: electronic |
| 15870 | 21 CFR 111.75(c)(1) | Specifications met - verify; production, process control |
| 15932 | 21 CFR 111.105(a) | Quality control - processes, specifications, written procedures |