FDA 483 - Dendreon Pharmaceuticals LLC - October 29, 2025

An FDA inspection of Dendreon Pharmaceuticals LLC in Union City, GA, revealed significant deficiencies in laboratory record-keeping and manufacturing process controls. The firm failed to maintain complete data for invalid test results for its PROVENGE® drug product and continued to use disinfectants despite failed efficacy studies without proper investigation. These issues indicate a lack of robust quality control and data integrity.