# FDA 483 - University of Texas Medical Branch at Galveston - September 11, 2019

Source: https://www.keypedia.com/records/483/university-of-texas-medical-branch-at-galveston/c83195b6-7271-497c-92f2-b7e167a66e37

> FDA 483 for University of Texas Medical Branch at Galveston on September 11, 2019. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: University of Texas Medical Branch at Galveston
- Inspection Date: 2019-09-11
- Product Type: biologics
- Office Name: Dallas District Office
- Summary: The FDA inspected the University of Texas Medical Branch (UTMB) Blood Center in Galveston, TX, on September 10-11, 2019. The inspection revealed a significant issue with record-keeping for emergency blood transfusions. Specifically, a number of emergency release forms lacked complete documentation justifying the emergency action, indicating a lapse in maintaining adequate records.

## Related Officers

- [Investigator](https://www.keypedia.com/people/darla-j-christopher/64d3f47f-f3c0-4cfd-a3e8-4dc0e69d04bd)

Company: https://www.keypedia.com/companies/university-of-texas-medical-branch-at-galveston/e440c8a2-e5df-4af6-be02-4e7d41b255ac

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