FDA 483 - Lonza Biologics, Inc. - July 21, 2023

An FDA inspection of Lonza Biologics, Inc. in Portsmouth, NH, revealed a significant issue regarding the qualification of critical manufacturing equipment. The firm failed to adequately qualify a Grade A bottle filler, specifically in demonstrating unidirectional airflow during both static and dynamic operations. This deficiency raises concerns about the control of the aseptic processing environment for drug substance manufacturing.