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1195562

Island Reproductive Services — FEI 3011393636

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
January 26, 2023
Fiscal Year
2023
Product Type
Biologics
Project Area
Human Cellular, Tissue, and Gene Therapies
Location
Staten Island, NY (United States)

Facility

Other inspections at this facility

  • 1267810 (NAI Thu Apr 17 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1102408 (NAI Thu Sep 12 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1002516 (NAI Thu Feb 16 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 921812 (VAI Tue Apr 14 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 830435 (NAI Fri May 03 2013 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
1222221 CFR 1271.47(a)Design of procedures to ensure compliance
1222921 CFR 1271.50(a)Determination based on screening and testing
1223721 CFR 1271.55(a)(3)Summary--records used to make determination
1224721 CFR 1271.55(d)(2)Accurate, indelible, legible
1227721 CFR 1271.75(a)(1)Risk factors, clinical evidence