FDA Inspection 981568 — Teva Branded Pharmaceutical Products R&D
The FDA completed an inspection of Teva Branded Pharmaceutical Products R&D on Jun 30, 2016 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). 6 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jun 30, 2016
- Fiscal Year
- 2016
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- Horsham, PA (United States)
Additional Details
Postmarket Adverse Drug Experience (PADE)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 3570 | 21 CFR 211.100(a) | Approval and review of procedures |
| 6730 | 21 CFR 314.80(b) | Failure to develop written procedures |
| 6732 | 21 CFR 314.80(c)(1)(i) | Late submission of 15-day report |
| 6831 | 21 CFR 314.80(c)(2) | Late submission of quarterly safety reports |
| 8938 | FDCA 760(c)(1) | Timing of AE report submission (non-RX drugs) |