FDA 483 - Dendreon Pharmaceuticals LLC - January 09, 2015

An FDA inspection of U.S. Manufacturing Operations in Union City, GA, a cellular therapy manufacturer, revealed two significant observations. The firm's Quality Assurance Unit failed to ensure thorough review and adequate evaluation of customer complaints, including initiating adverse events for unreleased products with low cell counts. Additionally, corrective actions implemented to prevent training investigation exception reports were found to be inadequate, with ongoing issues related to employee training records.