FDA Inspection 1045799 — Medicine Invention Design Incorporation IRB
The FDA completed an inspection of Medicine Invention Design Incorporation IRB on Mar 27, 2018 in Rockville, MD. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 4 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI)
- End Date
- Mar 27, 2018
- Fiscal Year
- 2018
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- Rockville, MD (United States)
Additional Details
IRB
Citations
| ID | CFR | Description |
|---|---|---|
| 7277 | 21 CFR 56.107(d) | One non-affiliate member |
| 7278 | 21 CFR 56.107(e) | Conflict of interest |
| 7318 | 21 CFR 56.115(a)(2) | Minutes of IRB meetings |
| 7335 | 21 CFR 56.115(a)(6) | Written procedures per 56.108(a) and (b) |