FDA Inspection 955833 — University Of Miami, Human Subjects Research Office, Medical IRB

University Of Miami, Human Subjects Research Office, Medical IRB — FEI 1044676

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

IDCFRDescription
720921 CFR 50.25(a)(1)Procedures, identification of those which were experimental
739121 CFR 50.25(a)(5)Confidentiality, FDA inspection of records