645466
Teva Pharmaceuticals USA, Inc — FEI 3003092769
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 1, 2010
- Fiscal Year
- 2010
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Parsippany, NJ (United States)
Citations
| ID | CFR | Description |
| 2419 | 21 CFR 211.198(a) | Complaint Handling Procedure |
| 2567 | 21 CFR 211.198(a) | Adverse Drug Experience |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |
| 8908 | 21 CFR 314.81(b)(2)(i) | Summary |
| 8911 | 21 CFR 314.81(b)(1)(ii) | Failure to meet specifications |