1075190

Genesis Fertility & Reproductive Medicine — FEI 3003972326

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
December 21, 2018
Fiscal Year
2019
Product Type
Biologics
Project Area
Human Cellular, Tissue, and Gene Therapies
Location
Brooklyn, NY (United States)

Citations

IDCFRDescription
1221321 CFR 1271.47(a)Testing, screening, donor eligibility procedures
1227721 CFR 1271.75(a)(1)Risk factors, clinical evidence
1228221 CFR 1271.75(d)Donors with risks not determined ineligible