Lonza Biologics, Inc. – FDA 483, Feb 6, 2026

An FDA inspection of Lonza Biologics, Inc. in Portsmouth, NH, a drug substance manufacturer, revealed four significant observations. These included inadequate laboratory control mechanisms for impurity estimation, deficiencies in the equipment cleaning program, failure to adhere to aseptic behaviors and techniques, and a lack of qualification for non-compendial reference standards. The findings indicate several areas where the firm's quality systems and manufacturing practices require improvement to ensure product quality and safety.