1175515
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- July 27, 2022
- Fiscal Year
- 2022
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- Parsippany, NJ (United States)
Additional Details
Postmarket Adverse Drug Experience (PADE)
Citations
| ID | CFR | Description |
|---|---|---|
| 18025 | 21 CFR 314.80(c)(2)(ii)(B) | Late submission of an ICSR |
| 18028 | 21 CFR 314.80(f)(4) | Incomplete initial reporter information on ICSR |
| 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 |
| 6735 | 21 CFR 314.80(c)(1)(ii) | Failure to investigate serious, unexpected events |
| 8912 | 21 CFR 314.81(b)(2) | Timely submission |