FDA 483 - University of Texas Medical Branch - September 15, 2023

The University of Texas Medical Branch in Galveston, TX, was cited for multiple deficiencies in its non-clinical laboratory operations during an FDA inspection. Observations included unauthorized and undocumented deviations from SOPs, inadequate data recording and archiving, and a lack of qualification or validation for critical laboratory equipment. These issues indicate significant concerns regarding data integrity and adherence to established procedures.