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596205

Stembanc Inc — FEI 3004195871

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
August 31, 2009
Fiscal Year
2009
Product Type
Biologics
Project Area
Human Cellular, Tissue, and Gene Therapies
Location
Chardon, OH (United States)

Facility

Other inspections at this facility

  • 1242190 (NAI Thu Jun 06 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1153328 (NAI Thu Sep 23 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 862242 (VAI Wed Feb 12 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 814359 (VAI Mon Feb 04 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 659051 (VAI Tue Apr 27 2010 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
1222121 CFR 1271.47(a)Procedures for all other requirements
1222921 CFR 1271.50(a)Determination based on screening and testing
1223021 CFR 1271.50(a)Responsible person to determine, document
1227021 CFR 1271.65(a)Improper release prevention--storage, I.D.
1228521 CFR 1271.80(a)Birth mother sample not tested
1230121 CFR 1271.150(c)(1)(iii)Ensurane of compliance
1235921 CFR 1271.195(a)(3)Aseptic processing---cleaning, disinfecting
1239921 CFR 1271.230(a)Process validation procedures
1243221 CFR 1271.265(e)Documentation elements for activities
1243721 CFR 1271.270(a)Records incomplete