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601811

California Cryobank LLC — FEI 3005342355

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
August 7, 2009
Fiscal Year
2009
Product Type
Biologics
Project Area
Human Cellular, Tissue, and Gene Therapies
Location
Los Angeles, CA (United States)

Facility

Other inspections at this facility

  • 1246354 (NAI Tue Aug 06 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1066638 (NAI Tue Sep 25 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 989122 (NAI Thu Aug 18 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 868705 (NAI Thu Feb 27 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 844713 (NAI Thu Aug 15 2013 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
1222121 CFR 1271.47(a)Procedures for all other requirements
1231921 CFR 1271.160(b)(3)Actions taken and documented
1235921 CFR 1271.195(a)(3)Aseptic processing---cleaning, disinfecting
1236421 CFR 1271.195(c)Monitoring-microorganisms where appropriate
1237621 CFR 1271.210(b)Use of non-sterile reagents
1239821 CFR 1271.230(a)Validation & approval--established procedures
1239921 CFR 1271.230(a)Process validation procedures