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959460

Yale Center For Reproductive Medicine & Infertility — FEI 3003926786

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
February 19, 2016
Fiscal Year
2016
Product Type
Biologics
Project Area
Human Cellular, Tissue, and Gene Therapies
Location
Orange, CT (United States)

Facility

Other inspections at this facility

  • 1216884 (NAI Mon Aug 28 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1129860 (NAI Wed Sep 23 2020 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1045768 (NAI Thu Mar 15 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 833179 (NAI Fri May 24 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 710786 (NAI Thu Feb 24 2011 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
1224621 CFR 1271.55(d)(1)(iii)Documentation--determination, by whom, date
1224721 CFR 1271.55(d)(2)Accurate, indelible, legible
1228221 CFR 1271.75(d)Donors with risks not determined ineligible
1249621 CFR 1271.85(b)(2)SOP for release; reactive for CMV