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759525

Institute for Human Reproduction (IHR), SC — FEI 3005919688

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
May 10, 2012
Fiscal Year
2012
Product Type
Biologics
Project Area
Human Cellular, Tissue, and Gene Therapies
Location
Chicago, IL (United States)

Facility

Other inspections at this facility

  • 1221029 (VAI Wed Oct 25 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1118808 (VAI Tue Feb 25 2020 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1095190 (NAI Thu Jun 13 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1014972 (NAI Wed Jun 07 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 978097 (NAI Fri Jul 08 2016 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
1221321 CFR 1271.47(a)Testing, screening, donor eligibility procedures
1222321 CFR 1271.47(b)Review and approval of procedures
1222921 CFR 1271.50(a)Determination based on screening and testing
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
1249021 CFR 1271.85(b)(1)Cell-associated CD
1249221 CFR 1271.85(a)Infection with communicable disease agents