FDA 483 - Lonza Tampa LLC - August 22, 2025

Lonza Tampa LLC, a contract drug manufacturer, was inspected by the FDA from August 18-22, 2025. The inspection revealed significant deficiencies across multiple areas, including inadequate microbial control procedures, insufficient laboratory controls, poor equipment cleaning and maintenance, and issues with HVAC system documentation. These findings indicate a concerning lack of adherence to cGMP standards, potentially impacting drug product quality and safety.