FDA 483 - SEAGEN INC. - May 13, 2025

An FDA inspection of SEAGEN INC. in Bothell, WA, a drug intermediate manufacturer, identified deficiencies in the training and qualification process for operators performing aseptic filling of PADCEV mAb intermediate. The firm's qualification procedures were found to be inadequate in both initial training and evaluating continued proficiency, including the use of commercial lots for final qualification and a lack of periodic re-qualification requirements. These issues indicate a potential risk to product quality and patient safety.