FDA 483 - University of Texas Southwestern Medical Center, The - May 15, 2026

The University of Texas Southwestern Medical Center in Dallas, a PET drug producer, was cited for failing to follow procedures for investigating nonconforming drug product batches. Specifically, a Corrective Action/Preventive Action (CAPA) for elevated microbial counts was not formally closed, sterility testing failures were not investigated, and the firm's CAPA procedures lacked clear criteria for distinguishing between different types of reports. These issues indicate a significant lapse in quality control and investigation processes for drug products.