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1112144

Boca Fertility — FEI 3003926589

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
December 5, 2019
Fiscal Year
2020
Product Type
Biologics
Project Area
Human Cellular, Tissue, and Gene Therapies
Location
Boca Raton, FL (United States)

Facility

Other inspections at this facility

  • 1221664 (VAI Wed Nov 01 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1061244 (VAI Mon Aug 06 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 985391 (VAI Tue May 03 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 823857 (NAI Thu Mar 21 2013 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
1221321 CFR 1271.47(a)Testing, screening, donor eligibility procedures
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