FDA 483 - Zydus Lifesciences Limited - June 18, 2025

Zydus Lifesciences Limited in Matoda, Gujarat, India, a sterile drug product manufacturer, was cited with two observations during an FDA inspection. The inspection revealed significant deficiencies in the Quality Unit's procedures for investigating invalid laboratory results and a lack of adequate validation for aseptic process simulation studies, raising concerns about product sterility assurance.