Conceive Fertility CenterOctober 15, 2021

FDA 483 - Conceive Fertility Center - October 15, 2021

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Record Details

Conceive Fertility Center in Irving, TX, a reproductive HCT/P establishment, was cited for significant deficiencies in its donor eligibility program. The inspection revealed a lack of established and maintained procedures for testing, screening, and determining HCT/P donor eligibility, affecting 102 donors. Additionally, the firm failed to test oocyte and semen donors for West Nile Virus during the WNV season in 2018.

Company: Conceive Fertility Center
Inspection Date: October 15, 2021
Product Type: Biologics
Office: Division of Human and Animal Food Operations - West III
Person: Decarlos A. Gomez

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ID · 900f1aca-bedf-429f-b94c-d190e334d51e