FDA 483 - Hovione LLC - November 17, 2022

An FDA inspection of Hovione LLC in East Windsor, NJ, from November 14-17, 2022, identified a significant issue with the calibration of mechanical equipment used in the manufacture of Trikafta Drug Product. The firm failed to perform routine calibration according to a written program, resulting in equipment being used outside its calibrated range or not on a routine schedule. This indicates a lapse in quality control over critical manufacturing processes.