671182
AstraZeneca Pharmaceuticals LP — FEI 3004829714
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- June 23, 2010
- Fiscal Year
- 2010
- Product Type
- Biologics
- Project Area
- Vaccines and Allergenic Products
- Location
- Philadelphia, PA (United States)
Citations
| ID | CFR | Description |
|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1451 | 21 CFR 211.113(b) | Procedures for sterile drug products |
| 2619 | 21 CFR 211.198(b)(2) | Complaint Investigation/Follow-Up Findings |
| 3632 | 21 CFR 211.170(b) | Annual visual exams of drug products |
| 4402 | 21 CFR 211.192 | Written record of investigation incomplete |