698506

University of Cincinnati Center For Reproductive Health — FEI 3010292882

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
November 22, 2010
Fiscal Year
2011
Product Type
Biologics
Project Area
Human Cellular, Tissue, and Gene Therapies
Location
West Chester, OH (United States)

Citations

IDCFRDescription
1223021 CFR 1271.50(a)Responsible person to determine, document
1227721 CFR 1271.75(a)(1)Risk factors, clinical evidence
1249321 CFR 1271.90(c)Eligibility not required--warning labels