FDA 483 - Resource Optimization & Innovation LLC - April 04, 2019

Resource Optimization & Innovation, LLC. in Springfield, MO, a repackager/relabeler, was cited for significant deficiencies in its quality system related to medical device reporting and complaint handling. The firm's procedures for determining reportable events and timely MDR submission were inadequate, and numerous complaints were not processed within established timeframes or justified for extension. These issues indicate a lack of robust controls over critical post-market surveillance activities.