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821099

StemCyte, Inc — FEI 3003562296

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
March 12, 2013
Fiscal Year
2013
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))
  • 736757 (NAI Thu Jul 28 2011 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 643295 (VAI Thu Feb 11 2010 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
1233621 CFR 1271.180(a)Procedures to meet core CTGP
1234621 CFR 1271.190(b)(2)Sewage, trash removal
1235821 CFR 1271.195(a)(2)Ventilation and air filtration controls
1236421 CFR 1271.195(c)Monitoring-microorganisms where appropriate
1241121 CFR 1271.260(a)Contamination, mix ups, improper release