FDA EIR - Dendreon Pharmaceuticals LLC - January 19, 2018

An FDA inspection of Dendreon Pharmaceuticals LLC's Seal Beach, CA facility occurred from January 9-19, 2018, focusing on Good Manufacturing Practices (GMP) for its CBER-licensed product, Provenge (sipuleucel-T). This visit followed a previous 2016 inspection that yielded four observations. The current inspection, however, concluded with a Form FDA 483 listing ten significant observations, indicating widespread deficiencies. Key issues identified included critical failures in aseptic processing and sterility assurance, such as inadequate procedures to prevent microbiological contamination, lack of post-use vent filter integrity testing, and insufficient sanitization practices for materials entering controlled environments. The sterilization process validation was also found lacking, evidenced by media simulation failures. Further concerns spanned the company's quality system and investigation practices, noting failures to thoroughly review unexplained discrepancies and an absence of established procedures for post-marketing adverse drug experience surveillance and reporting, particularly problematic following a recent acquisition. Laboratory controls were criticized for scientifically unsound specifications and deficient record-keeping, including discarded essential data. Additionally, facility construction was deemed unsuitable, allowing potential contaminant ingress into controlled manufacturing areas. Lastly, the inspection revealed the release of packaging and labeling materials that did not meet current specifications. These ten observations necessitate a robust and comprehensive response from Dendreon Pharmaceuticals LLC, outlining detailed corrective and preventive actions to ensure compliance with regulatory standards and safeguard product quality and patient safety.