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862242

Stembanc Inc — FEI 3004195871

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
February 12, 2014
Fiscal Year
2014
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))
  • 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))
  • 596205 (VAI Mon Aug 31 2009 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
1228521 CFR 1271.80(a)Birth mother sample not tested
1232521 CFR 1271.160(b)(6)Deviations--evaluation, cause, corrective action
1232621 CFR 1271.160(c)Quality audits performed periodically
1238721 CFR 1271.220(a)Causing contamination, increasing risks
1239821 CFR 1271.230(a)Validation & approval--established procedures
1243121 CFR 1271.265(e)Procedures and release criteria