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1266536

Kofinas Fertility Group — FEI 3004753467

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
April 9, 2025
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

  • 1210757 (VAI Tue Jul 25 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1122513 (NAI Thu Feb 13 2020 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1056801 (VAI Mon Jun 25 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 963390 (NAI Fri Mar 11 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 857553 (NAI Wed Dec 04 2013 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
1224721 CFR 1271.55(d)(2)Accurate, indelible, legible
1249321 CFR 1271.90(c)Eligibility not required--warning labels