FDA 483 - Lonza AG - March 28, 2023

An FDA inspection of Lonza AG in Visp, Switzerland, from March 20-28, 2023, identified a critical deficiency in the firm's laboratory record-keeping practices. The company failed to record exact microbial count values for both Total Aerobic Microbial Count in water and environmental monitoring action limit excursions. This omission of precise data, instead documenting only 'greater than' values, indicates a lack of complete data necessary to ensure compliance with established specifications for drug substance manufacturing.