601426
AstraZeneca Pharmaceuticals LP — FEI 3004829714
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- June 16, 2009
- Fiscal Year
- 2009
- Product Type
- Biologics
- Project Area
- Vaccines and Allergenic Products
- Location
- Philadelphia, PA (United States)
Citations
| ID | CFR | Description |
| 1451 | 21 CFR 211.113(b) | Procedures for sterile drug products |
| 3572 | 21 CFR 211.100(b) | Procedure Deviations Recorded and Justified |
| 3591 | 21 CFR 211.110(b) | In-process materials specifications |
| 9086 | 21 CFR 600.14(a)(1) | Who must report - manufacturer |
| 9089 | 21 CFR 600.14(c) | When to report |