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1048798

Polcz Fertility Lab, LLC — FEI 3003926583

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
April 19, 2018
Fiscal Year
2018
Product Type
Biologics
Project Area
Human Cellular, Tissue, and Gene Therapies
Location
Boynton Beach, FL (United States)

Facility

Other inspections at this facility

  • 1222743 (NAI Tue Nov 14 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1172846 (NAI Mon Jun 27 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 941582 (NAI Thu Sep 10 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 838539 (NAI Thu Jun 27 2013 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
1221321 CFR 1271.47(a)Testing, screening, donor eligibility procedures
1223621 CFR 1271.55(a)(2)Eligibility statement--basis of determination
1223821 CFR 1271.55(b)(1)Statement re: certified testing lab
1223921 CFR 1271.55(b)(2)Listing and interpretation of CD tests performed
1227721 CFR 1271.75(a)(1)Risk factors, clinical evidence