FDA 483 - American Fertility Medical Center - Genetic Infertility & Andrology Laboratory, Inc. - January 22, 2020

An FDA inspection of American Fertility Med Center, Genetic Infertility & Andrology Lab in Irvine, CA, revealed significant deficiencies in their reproductive tissue donor program. The firm failed to determine donor eligibility, lacked established procedures for screening and testing HCT/P donors, and inadequately screened for communicable disease risks, including HIV. Additionally, anonymous oocyte donors were improperly identified with personal information on HCT/P containers and records.