# FDA 483 - Texas Tech University Health Sciences Center Center for Fertility and Reproductive Surgery - September 21, 2022

Source: https://www.globalkeysolutions.net/records/483/texas-tech-university-health-sciences-center-center-for-fertility-and-reproductive-surgery/cae1c91a-88b8-4bae-a172-4f75cfbd697f

> FDA 483 for Texas Tech University Health Sciences Center Center for Fertility and Reproductive Surgery on September 21, 2022. Product: other. 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: 2022-09-21
- Product Type: other
- Office Name: Division of Human and Animal Food Operations - West III
- Summary: An FDA inspection of Texas Tech University Health Sciences Center in Lubbock, TX, identified significant violations related to donor screening and testing for communicable disease agents. The firm failed to collect donor specimens at appropriate times, did not test for all relevant communicable diseases, and neglected to properly screen donors through medical record reviews. Additionally, the facility used non-FDA-licensed tests for critical communicable disease agent screening, indicating serious deficiencies in their reproductive services.

## Related Documents

- [483 - 2023-07-26](https://www.globalkeysolutions.net/records/483/texas-tech-university-health-sciences-center-center-for-fertility-and-reproductive-surgery/ed03f751-aa2a-4d44-b9a3-1cc5c393b8ff)

## Related Officers

- [Emily S. McGann](https://www.globalkeysolutions.net/people/emily-s-mcgann/43891ff3-bd70-4337-b61c-e16cc7ad0468)
- [Gloria A. Milster](https://www.globalkeysolutions.net/people/gloria-a-milster/22f95276-6f68-467d-8d52-5c028c118123)

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