FDA Inspection 665436 — Teva Branded Pharmaceutical Products R&D
The FDA completed an inspection of Teva Branded Pharmaceutical Products R&D on May 19, 2010 in Horsham, PA. 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
- May 19, 2010
- Fiscal Year
- 2010
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- Horsham, PA (United States)
Additional Details
Postmarket Adverse Drug Experience (PADE)
Citations
| ID | CFR | Description |
|---|---|---|
| 6728 | 21 CFR 314.80(b) | Failure to review ADE information |
| 8908 | 21 CFR 314.81(b)(2)(i) | Summary |