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637139

Healthbanks Biotech USA Inc — FEI 3007390761

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
January 15, 2010
Fiscal Year
2010
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))
  • 723566 (VAI Tue May 17 2011 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
1222121 CFR 1271.47(a)Procedures for all other requirements
1231121 CFR 1271.160(b)(1)Ensuring appropriate core requirements followed
1235921 CFR 1271.195(a)(3)Aseptic processing---cleaning, disinfecting
1239921 CFR 1271.230(a)Process validation procedures
1240821 CFR 1271.250(c)All labeling requirements met
1249621 CFR 1271.85(b)(2)SOP for release; reactive for CMV