FDA 483 - Celltrion Inc. - October 22, 2019

An FDA inspection of Celltrion Inc., a sterile pharmaceutical manufacturer in Incheon, Korea, revealed a significant deficiency in aseptic processing areas. The firm's dynamic airflow visualization studies for its restricted access barrier system were found to be inadequate, failing to properly visualize airflow at critical areas during simulated interventions. This indicates a potential risk to the sterility of parenteral drug products.