FDA Inspection 1037207 — Medstar Health Research Institute IRB
The FDA completed an inspection of Medstar Health Research Institute IRB on January 10, 2018 in Hyattsville, MD. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- January 10, 2018
- Fiscal Year
- 2018
- Product Type
- Devices
- Project Area
- Bioresearch Monitoring
- Location
- Hyattsville, MD (United States)
Additional Details
IRB
Citations
| ID | CFR | Description |
|---|---|---|
| 7281 | 21 CFR 56.108(a)(1) | Initial and continuing reviews |
| 7317 | 21 CFR 56.115(a)(1) | Copies of all research proposals and related documents |
| 7334 | 21 CFR 56.115(a)(5) | List of members |