# FDA 483 - Conceive Fertility Center - June 13, 2025

Source: https://www.globalkeysolutions.net/records/483/conceive-fertility-center/f6d9c398-e130-4013-9659-0b8ffe9087b5

> FDA 483 for Conceive Fertility Center on June 13, 2025. Product: biologics. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Conceive Fertility Center
- Inspection Date: 2025-06-13
- Product Type: biologics
- Office Name: Dallas District Office
- Summary: The inspection of Conceive Fertility Center in Dallas, TX, revealed significant deficiencies in donor eligibility determination and documentation for Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps). Observations included failures to properly state donor eligibility, ensure qualified personnel performed determinations, establish procedures for CMV reactive donors, and maintain comprehensive donor eligibility procedures, along with issues regarding non-English donor information. These issues indicate a lack of robust controls over critical aspects of HCT/P donor screening and eligibility.

## Related Documents

- [483 - 2021-10-15](https://www.globalkeysolutions.net/records/483/conceive-fertility-center/900f1aca-bedf-429f-b94c-d190e334d51e)
- [WARNING_LETTER - 2025-06-13](https://www.globalkeysolutions.net/records/warning_letter/conceive-fertility-center/7c379197-7aaf-4e75-a19e-698b1e91d897)

## Related Officers

- [Ramon L. Gonzalez-Prieto](https://www.globalkeysolutions.net/people/ramon-l-gonzalez-prieto/f03487d2-7c8c-407f-8270-a838f7a7d127)

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

Office: https://www.globalkeysolutions.net/offices/dallas-district-office/2d1ee9ae-c44c-4494-8186-a920a69b98f9