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643295

StemCyte, Inc — FEI 3003562296

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
February 11, 2010
Fiscal Year
2010
Product Type
Biologics
Project Area
Human Cellular, Tissue, and Gene Therapies
Location
Baldwin Park, CA (United States)

Facility

Other inspections at this facility

  • 1101775 (NAI Wed Jul 31 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 821099 (VAI Tue Mar 12 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 736757 (NAI Thu Jul 28 2011 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
1222121 CFR 1271.47(a)Procedures for all other requirements
1232421 CFR 1271.160(b)(6)Deviations--Investigation, documenting, trending
1233721 CFR 1271.180(a)Design adequate to bar spread of CD's
1236421 CFR 1271.195(c)Monitoring-microorganisms where appropriate
1239921 CFR 1271.230(a)Process validation procedures