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1196726

Florida Fertility Institute, P.A. — FEI 3004586701

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
February 2, 2023
Fiscal Year
2023
Product Type
Biologics
Project Area
Human Cellular, Tissue, and Gene Therapies
Location
Clearwater, FL (United States)

Facility

Other inspections at this facility

  • 1230983 (NAI Wed Jan 24 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1122668 (NAI Tue Mar 10 2020 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1067758 (NAI Wed Jun 13 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 964118 (NAI Thu Jan 28 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 883830 (NAI Thu Jun 19 2014 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
1221321 CFR 1271.47(a)Testing, screening, donor eligibility procedures
1222121 CFR 1271.47(a)Procedures for all other requirements
1222921 CFR 1271.50(a)Determination based on screening and testing
1223021 CFR 1271.50(a)Responsible person to determine, document
1224221 CFR 1271.55(c)Name and personal info on accompanying records
1227221 CFR 1271.65(b)(2)Labeled re: biohazard, risks, test results
1227721 CFR 1271.75(a)(1)Risk factors, clinical evidence
1249321 CFR 1271.90(c)Eligibility not required--warning labels