FDA 483 - Lonza AG - April 04, 2025

Lonza AG, a drug product manufacturer in Visp, Switzerland, was cited for failing to establish and follow procedures designed to prevent microbiological contamination of sterile drug products. Inspectors observed deficiencies during dynamic smoke study videos, including operators covering sterile openings and blocking first air during critical aseptic operations. These issues indicate a lack of adherence to aseptic processing principles.