1214688

Dendreon Pharmaceuticals LLC — FEI 3008821247

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
August 10, 2023
Fiscal Year
2023
Product Type
Biologics
Project Area
Human Cellular, Tissue, and Gene Therapies
Location
Seal Beach, CA (United States)

Citations

IDCFRDescription
185121 CFR 211.84(e)Rejecting When Specifications Not Met
202821 CFR 211.192Extent of discrepancy, failure investigations