FDA Inspection 955833 — University Of Miami, Human Subjects Research Office, Medical IRB
The FDA completed an inspection of University Of Miami, Human Subjects Research Office, Medical IRB on Dec 24, 2015 in Coral Gables, FL. 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). 2 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Dec 24, 2015
- Fiscal Year
- 2016
- Product Type
- Food/Cosmetics
- Project Area
- Bioresearch Monitoring
- Location
- Coral Gables, FL (United States)
Additional Details
IRB
Citations
| ID | CFR | Description |
|---|---|---|
| 7209 | 21 CFR 50.25(a)(1) | Procedures, identification of those which were experimental |
| 7391 | 21 CFR 50.25(a)(5) | Confidentiality, FDA inspection of records |