Zydus Lifesciences Limited – FDA 483, Apr 25, 2025

Zydus Lifesciences Limited in Dabhasa, India, received a Form FDA 483 with six observations related to significant quality control and manufacturing deficiencies. Issues included inadequate complaint investigations, insanitary equipment, deficient GMP training, contamination risks from poor differential pressure control, failure to investigate product deviations, and insufficient water quality monitoring for API production. These findings indicate a serious lack of adherence to good manufacturing practices.