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765182

Berkeley Biologics LLC — FEI 1000100754

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
February 17, 2012
Fiscal Year
2012
Product Type
Biologics
Project Area
Human Cellular, Tissue, and Gene Therapies
Location
Richmond, CA (United States)

Facility

Other inspections at this facility

  • 1218588 (OAI Mon Sep 25 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1145973 (NAI Fri Jun 25 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1067125 (NAI Tue Aug 28 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 967555 (NAI Fri Mar 25 2016 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
1230921 CFR 1271.160(a)Program is appropriate for the HCT/Ps
1239821 CFR 1271.230(a)Validation & approval--established procedures
1241121 CFR 1271.260(a)Contamination, mix ups, improper release