FDA 483 - Lonza Biologics, Inc. - October 22, 2021

An FDA inspection of Lonza Biologics, Inc. in Portsmouth, NH, a vaccine drug substance manufacturer, revealed significant deficiencies. Observations included untimely investigations into deviations, improper handling of human errors during validation, and poor facility maintenance with issues like wall damage, gaps in doors, pest presence, and growth-like material. Additionally, the facility failed to timely repair numerous leaking pipes and equipment, indicating a lack of control over its infrastructure.