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723566

Healthbanks Biotech USA Inc — FEI 3007390761

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
May 17, 2011
Fiscal Year
2011
Product Type
Biologics
Project Area
Human Cellular, Tissue, and Gene Therapies
Location
Irvine, CA (United States)

Facility

Other inspections at this facility

  • 1131595 (NAI Fri Sep 25 2020 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1028798 (NAI Thu Sep 21 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 637139 (OAI Fri Jan 15 2010 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
1222121 CFR 1271.47(a)Procedures for all other requirements
1228221 CFR 1271.75(d)Donors with risks not determined ineligible
1229021 CFR 1271.80(d)(1)Reactive tests--not determined ineligible
1232521 CFR 1271.160(b)(6)Deviations--evaluation, cause, corrective action
1239921 CFR 1271.230(a)Process validation procedures