Zydus Lifesciences Limited – FDA 483, Sep 5, 2025

Zydus Lifesciences Limited, a sterile drug product manufacturer in Vadodara, India, was cited for significant deficiencies during an FDA inspection. Observations included inadequate investigations into microbial contamination and out-of-specification/out-of-trend results, deficient cleaning and disinfection procedures in aseptic processing areas, and a lack of controls to prevent environmental monitoring data manipulation. The firm also failed to adequately monitor environmental conditions in aseptic processing areas.