FDA 483 - University of Texas Southwestern Medical Center, The - September 09, 2019

An FDA inspection of the University of Texas Southwestern Medical Center, a PET drug manufacturer in Dallas, revealed three significant observations. The firm was cited for failing to verify and document test procedures for environmental monitoring, lacking established procedures for routine calibration of laboratory equipment, and not properly implementing procedures for equipment suitability and qualification, specifically regarding a smoke study for a laminar flow hood.