908758
Shandex Personal Care Manufacturing Inc. — FEI 3009051120
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- November 28, 2014
- Fiscal Year
- 2015
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Perth (Canada)
Citations
| ID | CFR | Description |
|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1883 | 21 CFR 211.165(a) | Testing and release for distribution |
| 1890 | 21 CFR 211.165(e) | Test methods |
| 1912 | 21 CFR 211.166(a) | Written program not followed |
| 4314 | 21 CFR 211.84(d)(2) | Reports of Analysis (Components) |
| 4413 | 21 CFR 211.194(a)(8) | Second person sign off |