FDA Inspection 645466 — Teva Pharmaceuticals USA, Inc
The FDA completed an inspection of Teva Pharmaceuticals USA, Inc on Mar 1, 2010 in Parsippany, NJ. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 5 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Mar 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 |