FDA Inspection 706483 — Johns Hopkins Medicine Institutional Review Boards
The FDA completed an inspection of Johns Hopkins Medicine Institutional Review Boards on January 7, 2011 in Baltimore, MD. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- January 7, 2011
- Fiscal Year
- 2011
- Product Type
- Devices
- Project Area
- Bioresearch Monitoring
- Location
- Baltimore, MD (United States)
Additional Details
IRB
Citations
| ID | CFR | Description |
|---|---|---|
| 7318 | 21 CFR 56.115(a)(2) | Minutes of IRB meetings |
| 7334 | 21 CFR 56.115(a)(5) | List of members |