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

The University of Texas Medical Branch in Galveston, TX, received a Form FDA 483 following an inspection of its non-clinical labs. The inspection revealed several issues primarily related to study data integrity, adherence to SOPs, and equipment validation. Key concerns include unauthorized deviations, incomplete data recording, inadequate documentation of test articles, and untimely archiving of study materials.