FDA 483 - Dendreon Pharmaceuticals LLC - November 08, 2019

An FDA inspection of Dendreon Pharmaceuticals, LLC in Seal Beach, CA, a biologic drug manufacturer, revealed significant deficiencies across multiple areas. The firm was cited for issues including inadequate batch production records, untimely investigations into sterility failures, and a lack of proper procedures for aseptic processing and environmental monitoring. Additional concerns involved insufficient data verification, improper material handling and storage, and inadequate temperature control and equipment maintenance.