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1257162

Columbia University Fertility Center — FEI 3003972435

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
December 20, 2024
Fiscal Year
2025
Product Type
Biologics
Project Area
Human Cellular, Tissue, and Gene Therapies
Location
New York, NY (United States)

Facility

Other inspections at this facility

  • 1191445 (VAI Mon Nov 28 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1097178 (VAI Tue Jul 23 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1066635 (VAI Tue Sep 25 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 978264 (NAI Fri Jul 08 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 894377 (NAI Thu Aug 28 2014 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
1222921 CFR 1271.50(a)Determination based on screening and testing
1223021 CFR 1271.50(a)Responsible person to determine, document
1227221 CFR 1271.65(b)(2)Labeled re: biohazard, risks, test results
1228621 CFR 1271.80(b)Specimen collections not timely
1249621 CFR 1271.85(b)(2)SOP for release; reactive for CMV