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

Source: https://www.keypedia.com/records/483/conceive-fertility-center/732b65a9-c000-4d9b-9a13-4be267ce6f08

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

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## Details

- Record Type: 483
- Company Name: Conceive Fertility Center
- Inspection Date: 2025-06-13
- Product Type: biologics
- Office Name: Division of Human and Animal Food Operations - West III
- Summary: Conceive Fertility Center in Dallas, TX, was cited for multiple deficiencies related to Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P) donor eligibility and record-keeping. Observations included failures to properly document donor eligibility, ensure determinations were made by qualified personnel, establish procedures for CMV-reactive donors, and maintain donor information in English with authenticated translations. These issues indicate significant gaps in their quality system for HCT/P donor management.

## Related Documents

- [483 - 2021-10-15](https://www.keypedia.com/records/483/conceive-fertility-center/900f1aca-bedf-429f-b94c-d190e334d51e)
- [483 - 2025-06-13](https://www.keypedia.com/records/483/conceive-fertility-center/f6d9c398-e130-4013-9659-0b8ffe9087b5)
- [WARNING_LETTER - 2025-06-13](https://www.keypedia.com/records/warning_letter/conceive-fertility-center/7c379197-7aaf-4e75-a19e-698b1e91d897)

## Related Officers

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

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