791239

Oregon Health & Science University — FEI 3004147742

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
July 25, 2012
Fiscal Year
2012
Product Type
Biologics
Project Area
Human Cellular, Tissue, and Gene Therapies
Location
Portland, OR (United States)

Citations

IDCFRDescription
1223021 CFR 1271.50(a)Responsible person to determine, document
1224121 CFR 1271.55(b)(4)Reasons for ineligibility on summary
1248921 CFR 1271.90(c)(1)Autologous use only--labeling