695173

Oregon Health & Science University — FEI 3072905

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
October 25, 2010
Fiscal Year
2011
Product Type
Biologics
Project Area
Human Cellular, Tissue, and Gene Therapies
Location
Portland, OR (United States)

Citations

IDCFRDescription
1228821 CFR 1271.80(c)Manufacturer instructions not followed
1233621 CFR 1271.180(a)Procedures to meet core CTGP