# FDA 483 - Texas Tech University Health Sciences Center Center for Fertility and Reproductive Surgery - July 26, 2023

Source: https://www.globalkeysolutions.net/records/483/texas-tech-university-health-sciences-center-center-for-fertility-and-reproductive-surgery/ed03f751-aa2a-4d44-b9a3-1cc5c393b8ff

> FDA 483 for Texas Tech University Health Sciences Center Center for Fertility and Reproductive Surgery on July 26, 2023. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Texas Tech University Health Sciences Center Center for Fertility and Reproductive Surgery
- Inspection Date: 2023-07-26
- Product Type: biologics
- Office Name: Division of Human and Animal Food Operations - West III
- Summary: An FDA inspection of Texas Tech University Health Sciences Center, Center for Fertility and Reproductive Surgery, identified four significant issues. The firm failed to use FDA-licensed tests for communicable disease screening, did not quarantine HCT/Ps until donor eligibility was determined, and omitted required record summaries for shipped reproductive tissue. Additionally, the facility lacked adequate procedures for screening HCT/P donors, including for Zika Virus risk factors.

## Related Documents

- [483 - 2022-09-21](https://www.globalkeysolutions.net/records/483/texas-tech-university-health-sciences-center-center-for-fertility-and-reproductive-surgery/cae1c91a-88b8-4bae-a172-4f75cfbd697f)

## Related Officers

- [Emily S. McGann](https://www.globalkeysolutions.net/people/emily-s-mcgann/43891ff3-bd70-4337-b61c-e16cc7ad0468)

Company: https://www.globalkeysolutions.net/companies/texas-tech-university-health-sciences-center-center-for-fertility-and-reproductive-surgery/c3990bbe-e4cf-46ac-a835-b68148d72cd3

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