FDA 483 - Dendreon Pharmaceuticals LLC - August 10, 2023

Dendreon Pharmaceuticals LLC in Seal Beach, CA, was inspected from August 2-10, 2023, and received a Form FDA 483 with two observations. The inspection revealed failures in quality control, specifically regarding the rejection of components that did not meet specifications due to sealing issues, and inadequate investigations into particulate matter found in drug products. These issues indicate significant deficiencies in the firm's quality system and its ability to identify root causes and implement effective corrective actions.