FDA 483 - Dendreon Corporation

An FDA inspection of Dendreon Corporation's cell therapy manufacturing facility in Morris Plains, NJ, identified nine observations during a pre-license inspection for Sipuleucel-T. The observations primarily concern deficiencies in process validation, quality control laboratory procedures, adherence to validated hold times, and inadequate standard operating procedures (SOPs) for exception reporting, investigations, change control, and supplier audits. Additionally, issues with documentation for spreadsheet formulas and cGMP training were noted.