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1209453

Arizona Center for Reproductive Endocrinology & Infertility — FEI 3005391124

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
June 28, 2023
Fiscal Year
2023
Product Type
Biologics
Project Area
Human Cellular, Tissue, and Gene Therapies
Location
Tucson, AZ (United States)

Facility

Other inspections at this facility

  • 1237404 (NAI Wed Jun 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1172585 (VAI Wed Jun 22 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1150646 (NAI Thu Aug 26 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1014319 (NAI Wed Mar 22 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 942876 (NAI Wed Sep 16 2015 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
1221321 CFR 1271.47(a)Testing, screening, donor eligibility procedures
1223721 CFR 1271.55(a)(3)Summary--records used to make determination
1223921 CFR 1271.55(b)(2)Listing and interpretation of CD tests performed
1224221 CFR 1271.55(c)Name and personal info on accompanying records
1227721 CFR 1271.75(a)(1)Risk factors, clinical evidence
1228621 CFR 1271.80(b)Specimen collections not timely
1228721 CFR 1271.80(c)Kits not FDA approved, specifically labeled