1114257
Sagent Pharmaceuticals — FEI 3006167046
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- December 18, 2019
- Fiscal Year
- 2020
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Schaumburg, IL (United States)
Citations
| ID | CFR | Description |
|---|
| 1033 | 21 CFR 211.22(a) | Authority lacking to review records, investigate errors |
| 1079 | 21 CFR 211.22(a) | Contract drug products--lack of responsibility |
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1136 | 21 CFR 211.25(c) | Inadequate number of personnel |
| 1358 | 21 CFR 211.100(b) | SOPs not followed / documented |
| 8907 | 21 CFR 314.81(b)(1)(ii) | Contamination, chemical or physical change, deterioration |
| 8911 | 21 CFR 314.81(b)(1)(ii) | Failure to meet specifications |