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656066

Center For Reproductive Biology Of Indiana, LLC — FEI 3003973984

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
April 2, 2010
Fiscal Year
2010
Product Type
Biologics
Project Area
Human Cellular, Tissue, and Gene Therapies
Location
Carmel, IN (United States)

Facility

Other inspections at this facility

  • 1217819 (NAI Thu Sep 07 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1054282 (NAI Thu May 10 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 966091 (NAI Mon Apr 04 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 859511 (NAI Thu Dec 19 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 754501 (VAI Mon Nov 21 2011 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
1227721 CFR 1271.75(a)(1)Risk factors, clinical evidence
1228621 CFR 1271.80(b)Specimen collections not timely
1230121 CFR 1271.150(c)(1)(iii)Ensurane of compliance