FDA 483 - Lonza Biologics, Inc. - June 06, 2025

An FDA inspection of Lonza Portsmouth, Inc. in Portsmouth, NH, revealed significant deficiencies in the manufacturing of CASGEVY drug product. Observations included inadequate aseptic processing, cleaning procedures, documentation practices, and HVAC controls. The firm also demonstrated weaknesses in deviation management, environmental monitoring, sterility testing, and pest control programs.