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659051

Stembanc Inc — FEI 3004195871

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
April 27, 2010
Fiscal Year
2010
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))
  • 596205 (VAI Mon Aug 31 2009 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
1225221 CFR 1271.60(a)Completion of eligibility determination
1227021 CFR 1271.65(a)Improper release prevention--storage, I.D.
1227721 CFR 1271.75(a)(1)Risk factors, clinical evidence
1228821 CFR 1271.80(c)Manufacturer instructions not followed
1229121 CFR 1271.80(d)(2)Plasma diluted test specimens
1230121 CFR 1271.150(c)(1)(iii)Ensurane of compliance
1232221 CFR 1271.160(b)(4)Training of personnel
1232521 CFR 1271.160(b)(6)Deviations--evaluation, cause, corrective action
1233921 CFR 1271.180(c)Availability of procedures