FDA EIR - Lonza AG - March 28, 2023

An FDA surveillance inspection of Lonza AG, a non-sterile human and animal drug substance manufacturer based in Visp, Switzerland, was conducted from March 20-28, 2023. This inspection evaluated the facility's adherence to Current Good Manufacturing Practice (cGMP) standards for manufacturing operations, encompassing quality, facilities, equipment, production, materials, laboratory, and packaging/labeling systems. The regulatory framework for this assessment included CPGM Drug Manufacturing Inspections, Active Pharmaceutical Ingredient Process Inspections, and ICH Q7 Guidance.

The inspection identified one observation, documented on Form FDA-483. The main issue was Lonza AG's failure to report exact values for Total Aerobic Microbial Count (TAMC) and Environmental Monitoring action limit results. This indicates a deficiency in precise data recording for environmental control.

Lonza AG's management acknowledged the observation and committed to providing a written response detailing their corrective actions within fifteen business days. The inspection was classified as Voluntary Action Indicated (VAI), signifying that while an issue was noted, the company is expected to resolve it through its own actions. No other issues like refusals or sample collections occurred.