FDA 483 - SEAGEN INC. - June 10, 2022

Seagen Inc. North Creek, a drug substance intermediate manufacturer, was cited for significant deficiencies across multiple GMP areas during an FDA inspection. Observations included inadequate microbial control procedures, insufficient risk assessments for cross-contamination, and failures in manufacturing process adherence. Additionally, the firm was found to have untimely deviation investigations, incomplete documentation of GMP operations and deviations, and inadequately maintained manufacturing equipment.