980025
Neutraderm, Inc. — FEI 3006402197
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- July 22, 2016
- Fiscal Year
- 2016
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Chatsworth, CA (United States)
Citations
| ID | CFR | Description |
|---|
| 1086 | 21 CFR 211.22(b) | Adequate lab facilities not available |
| 1133 | 21 CFR 211.25(a) | GMP Training Frequency |
| 1177 | 21 CFR 211.63 | Equipment Design, Size and Location |
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 15630 | 21 CFR 111.180(b)(3)(i) | Document - required operation |
| 1809 | 21 CFR 211.160(a) | Following/documenting laboratory controls |
| 1842 | 21 CFR 211.84(d)(1) | Component identity verification |
| 1891 | 21 CFR 211.165(f) | Failing drug products not rejected |
| 1920 | 21 CFR 211.166(a)(3) | Valid stability test methods |
| 1942 | 21 CFR 211.180(e) | Records reviewed annually |
| 2020 | 21 CFR 211.188(b)(8) | Labeling Control Records and Label Copies |
| 3566 | 21 CFR 211.84(c)(4) | Composite sample top/middle/bottom |
| 4349 | 21 CFR 211.160(b)(2) | In-process samples representative, identified properly |
| 4352 | 21 CFR 211.160(b)(4) | Calibration - at intervals, written program, remedial action |