483
University of Texas Medical Branch at GalvestonFDA 483 - University of Texas Medical Branch at Galveston - September 11, 2019
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Record Details
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.
- Inspection Date
- September 11, 2019
- Product Type
- Biologics
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ID · c83195b6-7271-497c-92f2-b7e167a66e37