881210
Avara Liscate Pharmaceutical Services SPA — FEI 3004640070
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- May 13, 2014
- Fiscal Year
- 2014
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Liscate (Italy)
Citations
| ID | CFR | Description |
|---|
| 1194 | 21 CFR 211.42(c) | Defined areas of adequate size for operations |
| 1263 | 21 CFR 211.68(b) | Computer control of master formula records |
| 1434 | 21 CFR 211.42(c)(10)(iv) | Environmental Monitoring System |
| 1435 | 21 CFR 211.42(c)(10)(v) | Cleaning System |
| 1452 | 21 CFR 211.113(b) | Validation lacking for sterile drug products |
| 1809 | 21 CFR 211.160(a) | Following/documenting laboratory controls |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 2031 | 21 CFR 211.194(a) | Complete test data included in records |
| 3632 | 21 CFR 211.170(b) | Annual visual exams of drug products |
| 4352 | 21 CFR 211.160(b)(4) | Calibration - at intervals, written program, remedial action |