FDA Inspection 1159429 — Robert Wood Johnson U Hosp @ Hamilton IRB
The FDA completed an inspection of Robert Wood Johnson U Hosp @ Hamilton IRB on Dec 22, 2021 in Hamilton, 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). 4 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Dec 22, 2021
- Fiscal Year
- 2022
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- Hamilton, NJ (United States)
Additional Details
IRB
Citations
| ID | CFR | Description |
|---|---|---|
| 7316 | 21 CFR 56.115(a)(4) | Copies of IRB/CI correspondence |
| 7318 | 21 CFR 56.115(a)(2) | Minutes of IRB meetings |
| 7337 | 21 CFR 56.115(b) | Retention of records |
| 7692 | 21 CFR 56.106(e) | Changes in contact or chairperson information |