FDA 483 - University of Missouri - Columbia Research Reactor Center - August 15, 2019

An FDA inspection of Missouri University Reactor Research (MURR) in Columbia, MO, identified a significant deficiency in their record-keeping practices. The firm failed to maintain records for annual product reviews, specifically for Lutetium (LU-177) and another drug product, with the last reviews conducted in 2016. This indicates a lapse in evaluating drug product quality standards and determining the need for changes in manufacturing or control procedures.