Home / Inspections / 1218588

1218588

Berkeley Biologics LLC — FEI 1000100754

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
September 25, 2023
Fiscal Year
2023
Product Type
Biologics
Project Area
Human Cellular, Tissue, and Gene Therapies
Location
Richmond, CA (United States)

Facility

Other inspections at this facility

  • 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))
  • 765182 (VAI Fri Feb 17 2012 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
1222221 CFR 1271.47(a)Design of procedures to ensure compliance
1227721 CFR 1271.75(a)(1)Risk factors, clinical evidence
1228221 CFR 1271.75(d)Donors with risks not determined ineligible
1232221 CFR 1271.160(b)(4)Training of personnel
1239821 CFR 1271.230(a)Validation & approval--established procedures