FDA 483 - Dendreon Corporation

A pre-license inspection of Dendreon Corporation's cell therapy manufacturing facility in Morris Plains, NJ, revealed significant deficiencies. Observations included a lack of data to support concurrent manufacturing, insufficient personnel for aseptic process validation, and inadequate quality control for product identity. The inspection also cited issues with standard operating procedures, including missing timeframes for report closures, lack of regulatory review for change controls, and undefined auditor qualifications, alongside insufficient documentation for formulas and cGMP training.