1119812
BioConnection B.V. — FEI 3011445650
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 4, 2020
- Fiscal Year
- 2020
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Oss (Netherlands)
Citations
| ID | CFR | Description |
|---|
| 1049 | 21 CFR 211.22(a) | Approve or reject components, products |
| 1434 | 21 CFR 211.42(c)(10)(iv) | Environmental Monitoring System |
| 1435 | 21 CFR 211.42(c)(10)(v) | Cleaning System |
| 1451 | 21 CFR 211.113(b) | Procedures for sterile drug products |
| 1452 | 21 CFR 211.113(b) | Validation lacking for sterile drug products |
| 2019 | 21 CFR 211.188(b)(7) | Documentation of Actual Yield and Theoretical Yield |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 3583 | 21 CFR 211.110(a) | Written in-process control procedures |