FDA 483 - Lonza AG - October 28, 2025

Lonza AG, a drug substance manufacturer in Visp, Switzerland, received a Form 483 with four observations during an FDA inspection. The findings indicate significant issues with data integrity, including discrepancies in drug substance shelf life and inadequate integrity test procedures. Additionally, the firm was cited for insufficient control of process parameters leading to out-of-specification results and a lack of proper tracking, maintenance, and calibration for critical manufacturing materials and equipment.