FDA Inspection 715000 — St. Joseph's Health Care System IRB
The FDA completed an inspection of St. Joseph's Health Care System IRB on February 17, 2011 in Paterson, NJ. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- February 17, 2011
- Fiscal Year
- 2011
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- Paterson, NJ (United States)
Additional Details
IRB
Citations
| ID | CFR | Description |
|---|---|---|
| 7281 | 21 CFR 56.108(a)(1) | Initial and continuing reviews |
| 7293 | 21 CFR 56.109(f) | Continuing review |
| 7334 | 21 CFR 56.115(a)(5) | List of members |
| 7371 | 21 CFR 56.108(a)(1) | Reporting findings and actions to investigator/institution |