946109
Advanced Infusion Solutions — FEI 3011804748
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- October 27, 2015
- Fiscal Year
- 2016
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Ridgeland, MS (United States)
Citations
| ID | CFR | Description |
|---|
| 1421 | 21 CFR 211.42(c)(10) | Aseptic Processing Area |
| 1434 | 21 CFR 211.42(c)(10)(iv) | Environmental Monitoring System |
| 1435 | 21 CFR 211.42(c)(10)(v) | Cleaning System |
| 1436 | 21 CFR 211.42(c)(10)(vi) | Equipment to control conditions |
| 1451 | 21 CFR 211.113(b) | Procedures for sterile drug products |
| 1932 | 21 CFR 211.167(a) | Sterility/pyrogen-free testing |