# FDA 483 - Fertility and Advanced Reproductive Medicine at UTSW - December 13, 2023

Source: https://www.globalkeysolutions.net/records/483/fertility-and-advanced-reproductive-medicine-at-utsw/2150a048-de3b-4cbb-b233-a0dca5cb4dbd

> FDA 483 for Fertility and Advanced Reproductive Medicine at UTSW on December 13, 2023. Product: biologics. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Fertility and Advanced Reproductive Medicine at UTSW
- Inspection Date: 2023-12-13
- Product Type: biologics
- Office Name: Division of Human and Animal Food Operations - West III
- Summary: An FDA inspection of Fertility and Advanced Reproductive Medicine at UTSW in Dallas, TX, revealed significant issues with donor eligibility and HCT/P handling. The firm failed to ensure donor testing was negative for communicable disease agents, maintain proper documentation of donor eligibility, and adequately screen donors for disease risk factors. Additionally, HCT/Ps not requiring eligibility determination lacked appropriate warning labels.

## Related Officers

- [Ramon L. Gonzalez-Prieto](https://www.globalkeysolutions.net/people/ramon-l-gonzalez-prieto/f03487d2-7c8c-407f-8270-a838f7a7d127)
- [Bobbi Miller](https://www.globalkeysolutions.net/people/bobbi-miller/60517ce9-0fee-4099-98ef-c7329af0518a)

Company: https://www.globalkeysolutions.net/companies/fertility-and-advanced-reproductive-medicine-at-utsw/8a7e1c9f-a6fe-4e68-a856-fa32625b6e73

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