# FDA 483 - Conceive Fertility Center - October 15, 2021

Source: https://www.keypedia.com/records/483/conceive-fertility-center/900f1aca-bedf-429f-b94c-d190e334d51e

> FDA 483 for Conceive Fertility Center on October 15, 2021. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Conceive Fertility Center
- Inspection Date: 2021-10-15
- Product Type: biologics
- Office Name: Division of Human and Animal Food Operations - West III
- Summary: 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.

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## Related Officers

- [Decarlos A. Gomez](https://www.keypedia.com/people/decarlos-a-gomez/4b003235-edbb-4cb5-acb1-4e154941578c)

Company: https://www.keypedia.com/companies/conceive-fertility-center/61216c92-e61d-4550-9721-2e424669dde8

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-west-iii/2cda09a5-06c4-433f-9df0-0d7903a6efab