FDA 483 - Zydus Lifesciences Limited - May 05, 2026

An FDA inspection of Zydus Lifesciences Limited in Ahmedabad, India, a sterile drug manufacturer, revealed significant deficiencies across its operations. The firm failed to adequately investigate discrepancies, maintain aseptic processing areas, and ensure proper environmental controls. These issues, including insufficient validation of sterilization processes and lack of electronic data review, indicate a serious risk to the sterility and quality of drug products intended for the U.S. market.