FDA Inspection 1012007 — Pennsylvania State University IRB
The FDA completed an inspection of Pennsylvania State University IRB on April 26, 2017 in University Park, PA. 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: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- April 26, 2017
- Fiscal Year
- 2017
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- University Park, PA (United States)
Additional Details
IRB
Citations
| ID | CFR | Description |
|---|---|---|
| 7390 | 21 CFR 50.25(a)(4) | Alternate procedures, courses of treatment |
| 7391 | 21 CFR 50.25(a)(5) | Confidentiality, FDA inspection of records |