1100975
Advanced Accelerator Applications (Italy) srl — FEI 3010175147
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 3, 2019
- Fiscal Year
- 2019
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Colleretto Giacosa (Italy)
Citations
| ID | CFR | Description |
|---|
| 1451 | 21 CFR 211.113(b) | Procedures for sterile drug products |
| 1790 | 21 CFR 211.80(b) | Handling and Storage to Prevent Contamination |
| 3583 | 21 CFR 211.110(a) | Written in-process control procedures |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |