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938861

Montefiore's Institute for Reproductive Medicine and Health — FEI 3003972343

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
August 10, 2015
Fiscal Year
2015
Product Type
Biologics
Project Area
Human Cellular, Tissue, and Gene Therapies
Location
Hartsdale, NY (United States)

Facility

Other inspections at this facility

  • 1215614 (NAI Wed Aug 16 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1148967 (NAI Mon Aug 16 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1088610 (NAI Fri May 03 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1008038 (NAI Wed Mar 22 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 847232 (NAI Fri Sep 06 2013 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
1222121 CFR 1271.47(a)Procedures for all other requirements
1227121 CFR 1271.65(b)(2)Prominently labeled (limited use)
1227721 CFR 1271.75(a)(1)Risk factors, clinical evidence
1228221 CFR 1271.75(d)Donors with risks not determined ineligible