FDA 483 - American Fertility Medical Center - Genetic Infertility & Andrology Laboratory, Inc. - January 22, 2020
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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.
- Inspection Date
- January 22, 2020
- Product Type
- Biologics
ID · db9a37de-744b-425a-816f-10bca14280f2