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958542

Center For Advanced Reproductive Medicine & Fertility — FEI 3003945126

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
February 11, 2016
Fiscal Year
2016
Product Type
Biologics
Project Area
Human Cellular, Tissue, and Gene Therapies
Location
Edison, NJ (United States)

Facility

Other inspections at this facility

  • 1244251 (NAI Mon Jul 15 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1167958 (NAI Thu Apr 14 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1096785 (NAI Fri Jul 19 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1002162 (NAI Fri Mar 03 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 888758 (NAI Fri Jul 25 2014 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
1221321 CFR 1271.47(a)Testing, screening, donor eligibility procedures
1223021 CFR 1271.50(a)Responsible person to determine, document
1227221 CFR 1271.65(b)(2)Labeled re: biohazard, risks, test results
1227721 CFR 1271.75(a)(1)Risk factors, clinical evidence
1228221 CFR 1271.75(d)Donors with risks not determined ineligible
1228621 CFR 1271.80(b)Specimen collections not timely
1249321 CFR 1271.90(c)Eligibility not required--warning labels