FDA 483 - Dendreon Pharmaceuticals LLC - March 25, 2026

Dendreon Pharmaceuticals LLC in Seal Beach, CA, a biological drug manufacturer, was cited for numerous significant deficiencies during an FDA inspection. The observations highlight critical failures in quality control, including inadequate investigations into product discrepancies, insufficient aseptic processing controls, lack of proper validation for manufacturing changes, and poor record-keeping practices for sterile drug product manufacturing. These issues indicate a systemic breakdown in ensuring the safety, quality, and purity of their Sipuleucel-T drug product.