FDA 483 - Lonza Biologics, Inc. - March 07, 2024

An FDA inspection of Lonza Biologics, Inc. in Portsmouth, NH, a biological drug substance manufacturer, revealed two significant observations. The firm failed to adequately investigate unexplained discrepancies related to calibration data and incorrectly assessed failing data as passing. Additionally, the company did not follow its own established procedures for process descriptions, continuing manufacturing even after critical test failures were identified for bulk drug substances.