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1261685

InVia Fertility Specialists, PLLC — FEI 3004744097

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
February 5, 2025
Fiscal Year
2025
Product Type
Biologics
Project Area
Human Cellular, Tissue, and Gene Therapies
Location
Hoffman Estates, IL (United States)

Facility

Other inspections at this facility

  • 1179220 (VAI Fri Sep 09 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1021498 (NAI Wed Jul 05 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 951017 (NAI Thu Nov 12 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 736457 (NAI Mon Jul 25 2011 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
1221321 CFR 1271.47(a)Testing, screening, donor eligibility procedures
1223821 CFR 1271.55(b)(1)Statement re: certified testing lab
1224021 CFR 1271.55(b)(3)Name and address on summary
1224621 CFR 1271.55(d)(1)(iii)Documentation--determination, by whom, date
1227021 CFR 1271.65(a)Improper release prevention--storage, I.D.
1227221 CFR 1271.65(b)(2)Labeled re: biohazard, risks, test results
1227721 CFR 1271.75(a)(1)Risk factors, clinical evidence
1228621 CFR 1271.80(b)Specimen collections not timely
1249221 CFR 1271.85(a)Infection with communicable disease agents