# University of Texas Medical Branch – FDA 483

Source: https://www.keypedia.com/records/483/university-of-texas-medical-branch/05592896-5645-470e-8b35-ef018b59321c

> FDA 483 for University of Texas Medical Branch on Unknown Date. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: University of Texas Medical Branch
- Product Type: other
- Office Name: Division of Human and Animal Food Operations - West III
- Summary: The University of Texas Medical Branch in Galveston, TX, a nonclinical laboratory, received two observations during an FDA inspection. Deficiencies included the study director's failure to archive raw data from implantable temperature loggers and the lack of periodic analysis for contaminants in animal feed used in studies. These issues indicate concerns with data integrity and animal welfare practices in nonclinical studies.

## Related Documents

- [483 - 2023-09-15](https://www.keypedia.com/records/483/university-of-texas-medical-branch/90d4ac67-6d46-4e3a-b377-7b547c9fe197) — date: September 15, 2023

## Related Officers

- [Andrew R. Wasko](https://www.keypedia.com/people/andrew-r-wasko/87f194a2-d86b-4dad-8319-07f107ad8e6a)
- [Audrey J. Yarbrough](https://www.keypedia.com/people/audrey-j-yarbrough/1bab3d1a-3246-451e-96fb-4ce52185e850)
- [Ruth E. Medcalf](https://www.keypedia.com/people/ruth-e-medcalf/71a61d32-807b-4b73-9ea7-b59287e14e56)

Company: https://www.keypedia.com/companies/university-of-texas-medical-branch/c0139867-b3d2-4488-ae82-c4a642a0b377

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