FDA 483 - Zydus Lifesciences Limited - November 13, 2025

Zydus Lifesciences Limited in Matoda, Gujarat, India, a finished drug product manufacturer, was cited for significant deficiencies during an FDA inspection. The observations primarily concern inadequate validation of sterilization processes for sterile drug products and a failure to conduct adequate investigations into microbiological data deviations in aseptic processing areas. These issues indicate a lack of control over critical aspects of sterile manufacturing and quality system oversight.