483
University Of Texas MD Anderson Cancer CenterUniversity Of Texas MD Anderson Cancer Center – FDA 483, Aug 27, 2010
Record Details
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.
- Inspection date
- August 27, 2010
- Product type
- biologics
- Office
- Dallas District Office
- Person
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ID · 21399c22-d6b9-4714-a58a-18f2b0a781d8
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