FDA 483 - University of Iowa Pharmaceuticals (UIP) - May 04, 2018

University of Iowa Pharmaceuticals (UIP) in Iowa City, IA, was inspected and cited for four observations. Key issues included using expired ingredients without scientific justification for stability, inadequate validation of test methods for visual acuity, media-fills not simulating actual manufacturing processes, and deficient complaint procedures leading to unreported adverse drug reactions. These findings indicate significant concerns regarding quality control, aseptic processing, and post-market surveillance.