# FDA 483 - Scott & White Medical Center- Temple Andrology Laboratory - January 08, 2020

Source: https://www.keypedia.com/records/483/scott-white-medical-center-temple-andrology-laboratory/ef52b546-f8c9-4fee-bf1e-c9c7d79688e4

> FDA 483 for Scott & White Medical Center- Temple Andrology Laboratory on January 08, 2020. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Scott & White Medical Center- Temple Andrology Laboratory
- Inspection Date: 2020-01-08
- Product Type: other
- Office Name: Dallas District Office
- Summary: An FDA inspection of Scott & White Memorial Hospital Andrology Laboratory in Temple, TX, revealed multiple deficiencies related to donor screening, testing, and eligibility determination for Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps). The facility failed to adequately screen and test donors for communicable diseases, use FDA-licensed tests, collect specimens at appropriate times, and establish proper procedures for donor eligibility and HCT/P release. These observations highlight significant concerns regarding the safety and quality controls for reproductive HCT/Ps.

## Related Officers

- [Investigator](https://www.keypedia.com/people/abby-l-mozeke-baker/32e2896f-b836-4752-862e-de98370b8cad)

Company: https://www.keypedia.com/companies/scott-white-medical-center-temple-andrology-laboratory/c6834976-62d1-4ec1-83c9-cc1e8c72e9b7

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