843880
Sombra Cosmetics, Inc — FEI 1629960
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- July 26, 2013
- Fiscal Year
- 2013
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Albuquerque, NM (United States)
Citations
| ID | CFR | Description |
|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1112 | 21 CFR 211.25(a) | Training--operations, GMPs, written procedures |
| 1177 | 21 CFR 211.63 | Equipment Design, Size and Location |
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1358 | 21 CFR 211.100(b) | SOPs not followed / documented |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1540 | 21 CFR 211.125(a) | Strict control not exercised over labeling issued |
| 1728 | 21 CFR 211.87 | Retest of approved components/containers/closures |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 4317 | 21 CFR 211.84(d)(3) | Certificates of Testing (Containers, Closures) |
| 4412 | 21 CFR 211.194(a)(7) | Signatures and dates--person who performs test |