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1038072

Dendreon Pharmaceuticals LLC — FEI 3008821247

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
January 19, 2018
Fiscal Year
2018
Product Type
Biologics
Project Area
Human Cellular, Tissue, and Gene Therapies
Location
Seal Beach, CA (United States)

Facility

Other inspections at this facility

  • 1214688 (VAI Thu Aug 10 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1109236 (VAI Fri Nov 08 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 961300 (VAI Fri Jan 22 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 848259 (VAI Thu Nov 15 2012 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
116921 CFR 211.42(a)Buildings of Suitable Size, Construction, Location
145121 CFR 211.113(b)Procedures for sterile drug products
145221 CFR 211.113(b)Validation lacking for sterile drug products
149821 CFR 211.122(b)Labeling and packaging improperly approved/released
202721 CFR 211.192Investigations of discrepancies, failures
240121 CFR 211.194(a)(4)Complete Test Data
360321 CFR 211.160(b)Scientifically sound laboratory controls
440221 CFR 211.192Written record of investigation incomplete
909121 CFR 600.80(b)Review of Adverse Experiences - promptness
909321 CFR 600.80(b)Review of Adverse Experiences - SOPs