1148692
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 11, 2021
- Fiscal Year
- 2021
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- Paramus, NJ (United States)
Additional Details
Sponsor, Contract Research Organization
Citations
| ID | CFR | Description |
|---|---|---|
| 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 |
| 6829 | 21 CFR 314.80(c)(2) | Failure to report non-alert ADEs |