FDA Inspection 1022331 — Mercy Health System IRB
The FDA completed an inspection of Mercy Health System IRB on August 3, 2017 in Janesville, WI. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 7 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 3, 2017
- Fiscal Year
- 2017
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- Janesville, WI (United States)
Additional Details
IRB
Citations
| ID | CFR | Description |
|---|---|---|
| 7281 | 21 CFR 56.108(a)(1) | Initial and continuing reviews |
| 7316 | 21 CFR 56.115(a)(4) | Copies of IRB/CI correspondence |
| 7333 | 21 CFR 56.104(c) | Emergency use and IRB approval |
| 7334 | 21 CFR 56.115(a)(5) | List of members |
| 7342 | 21 CFR 56.108(b)(2) | Prompt reporting of noncompliance |
| 7371 | 21 CFR 56.108(a)(1) | Reporting findings and actions to investigator/institution |
| 7652 | 21 CFR 56.113 | Reporting |