FDA 483 - University of Iowa Pharmaceuticals (UIP) - June 22, 2023

An FDA inspection of University of Iowa Pharmaceuticals (UIP) in Iowa City, IA, revealed significant deficiencies in manufacturing controls. Observations included inadequate process validation, failure to conduct specific identification tests on components, insufficient aseptic process validation, and a lack of proper procedures for investigating product complaints. These issues indicate a need for comprehensive corrective actions to ensure product quality and patient safety.