FDA 483 - Lonza AG - October 28, 2025

From October 20 to October 28, 2025, the U.S. Food and Drug Administration (FDA) conducted an inspection of the Lonza AG drug substance manufacturing facility in Visp, Switzerland. This inspection resulted in the issuance of a Form 483, which identifies several significant quality and process control concerns. Primary violations included inconsistencies in drug substance shelf-life data, where the shelf life applied to specific production batches did not match the documentation provided to the agency. Additionally, the facility failed to follow vendor recommendations and internal standard operating procedures for equipment integrity testing, particularly regarding test setup and observation times. The FDA also noted that manufacturing process parameters were not adequately controlled, resulting in critical deviations and drug substance batches that failed to meet release specifications or produced borderline results. Finally, the site lacked a proactive maintenance and tracking system for critical equipment, such as integrity testers and bag sealers, often relying on a failure-based replacement model rather than preventative care. These observations fall under the regulatory framework of the Federal Food, Drug, and Cosmetic Act. Lonza AG is required to submit a formal response to the FDA detailing its corrective action plan, any objections to the findings, and a schedule for implementing improvements to ensure the facility meets the required manufacturing standards.