# FDA 483 - University Of Texas MD Anderson Cancer Center - August 27, 2010

Source: https://www.globalkeysolutions.net/records/483/university-of-texas-md-anderson-cancer-center/21399c22-d6b9-4714-a58a-18f2b0a781d8

> FDA 483 for University Of Texas MD Anderson Cancer Center on August 27, 2010. 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: 2010-08-27
- Product Type: biologics
- Office Name: Dallas District Office
- Summary: The University of Texas MD Anderson Cancer Center in Houston, TX, received a Form 483 for failing to report a confirmed, fatal transfusion complication to the Director, Office of Compliance, Center for Biologics Evaluation and Research (CBER) within the required 7 days. The facility also failed to follow its own internal deviation procedure for reporting such fatalities. This indicates a significant lapse in regulatory reporting and adherence to internal protocols.

## Related Officers

- [Patricia M. Jacobs](https://www.globalkeysolutions.net/people/patricia-m-jacobs/57d5adb3-2f37-429d-8452-c3f7bb19c477)

Company: https://www.globalkeysolutions.net/companies/university-of-texas-md-anderson-cancer-center/27b25cee-d163-4e98-9a5b-c4cafde177ac

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