# FDA 483 - University of Texas Medical Branch - September 15, 2023

Source: https://www.keypedia.com/records/483/university-of-texas-medical-branch/e368a0d8-ce25-4948-be1f-59769db969f9

> FDA 483 for University of Texas Medical Branch on September 15, 2023. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: University of Texas Medical Branch
- Inspection Date: 2023-09-15
- Product Type: biologics
- Office Name: Division of Human and Animal Food Operations - West III
- Summary: The University of Texas Medical Branch in Galveston, TX, received a Form FDA 483 following an inspection of its non-clinical labs. The inspection revealed several issues primarily related to study data integrity, adherence to SOPs, and equipment validation. Key concerns include unauthorized deviations, incomplete data recording, inadequate documentation of test articles, and untimely archiving of study materials.

## Related Documents

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

## Related Officers

- [Audrey J. Yarbrough](https://www.keypedia.com/people/audrey-j-yarbrough/1bab3d1a-3246-451e-96fb-4ce52185e850)
- [CSO](https://www.keypedia.com/people/andrea-a-branche/9ffe9b53-7963-49a6-be4e-25e644f1759f)

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