FDA 483 - ModernaTX, Inc. - September 21, 2023

ModernaTX, Inc. in Norwood, MA, a licensed biological drug substance manufacturer, was cited for five observations during an FDA inspection. The firm failed to ensure proper cleaning of manufacturing equipment and validate cleaning processes, leading to potential contamination risks. Additionally, deficiencies were noted in inventory management with expired materials, adherence to written procedures for alarm responses and change control, and maintaining adequate cleanroom environmental controls.