# FDA 483 - University of Texas MD Anderson Cancer Center - May 12, 2022

Source: https://www.keypedia.com/records/483/university-of-texas-md-anderson-cancer-center/0a39fdeb-1af7-4313-a5a5-1538532b7425

> FDA 483 for University of Texas MD Anderson Cancer Center on May 12, 2022. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: University of Texas MD Anderson Cancer Center
- Inspection Date: 2022-05-12
- Product Type: biologics
- Office Name: Division of Human and Animal Food Operations - West III
- Summary: An FDA inspection of the University of Texas MD Anderson Cancer Center in Houston identified a significant deficiency in the handling of adverse donor reactions. The facility failed to prepare and maintain complete written reports of investigations, specifically lacking documented follow-up for a majority of reviewed donor reaction cases, including severe incidents requiring emergency medical services. This indicates a critical lapse in record-keeping and patient safety protocols.

## 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-md-anderson-cancer-center/aee7392a-e5ce-4f6f-b7ff-73c661da15cb

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