FDA 483 - Dendreon Corporation - November 02, 2018

Dendreon Pharmaceuticals, LLC in Seattle, WA, was cited for significant deficiencies in their analytical testing laboratory during an FDA inspection. The firm failed to maintain consistency between their internal documents and the Biologics License Application, exhibited poor control over computer systems leading to data integrity concerns, and inadequately investigated out-of-specification results. Additionally, the inspection revealed a lack of proper training re-qualification for analysts.