FDA 483 - Dendreon Pharmaceuticals LLC - April 21, 2022

Dendreon Pharmaceuticals LLC in Union City, GA, a drug manufacturer, was cited for three observations during an FDA inspection. The firm failed to ensure calibration equipment met accuracy limits, leading to out-of-tolerance pipettes used for PROVENGE® product testing. Additionally, investigations into batch failures lacked complete conclusions and follow-up, and product complaints were not closed within established timeframes, with extensions requested and missed.