727977

Oregon Health & Science University — FEI 3004147742

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
May 27, 2011
Fiscal Year
2011
Product Type
Biologics
Project Area
Human Cellular, Tissue, and Gene Therapies
Location
Portland, OR (United States)

Citations

IDCFRDescription
1223221 CFR 1271.50(b)(2)Donor testing not negative for CD agents
1224121 CFR 1271.55(b)(4)Reasons for ineligibility on summary
1224721 CFR 1271.55(d)(2)Accurate, indelible, legible
1228321 CFR 1271.75(e)Abbreviated procedure
1248921 CFR 1271.90(c)(1)Autologous use only--labeling
1249321 CFR 1271.90(c)Eligibility not required--warning labels