FDA Inspection 957596 — The Wright Center For Graduate Medical Education IRB
The FDA completed an inspection of The Wright Center For Graduate Medical Education IRB on Jan 15, 2016 in Scranton, PA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 5 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jan 15, 2016
- Fiscal Year
- 2016
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- Scranton, PA (United States)
Additional Details
IRB
Citations
| ID | CFR | Description |
|---|---|---|
| 7281 | 21 CFR 56.108(a)(1) | Initial and continuing reviews |
| 7286 | 21 CFR 56.108(b)(1) | Prompt reporting of unanticipated problems |
| 7293 | 21 CFR 56.109(f) | Continuing review |
| 7318 | 21 CFR 56.115(a)(2) | Minutes of IRB meetings |
| 7334 | 21 CFR 56.115(a)(5) | List of members |