FDA Inspection 703036 — Teva Pharmaceuticals USA, Inc
The FDA completed an inspection of Teva Pharmaceuticals USA, Inc on Dec 2, 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). 2 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Dec 2, 2010
- Fiscal Year
- 2011
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Parsippany, NJ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 4402 | 21 CFR 211.192 | Written record of investigation incomplete |
| 8911 | 21 CFR 314.81(b)(1)(ii) | Failure to meet specifications |