FDA 483 - Zydus Lifesciences Limited - April 05, 2025

An FDA inspection conducted from April 21-25, 2025, at Zydus Lifesciences Limited in Dabhasa, Gujarat, India, identified significant concerns regarding the manufacture of Active Pharmaceutical Ingredients (APIs). The inspection revealed multiple deviations from Current Good Manufacturing Practices (CGMP) designed to ensure pharmaceutical product quality.

Key observations included a critical failure of the quality unit to adequately investigate a customer complaint involving foreign material (a chewing product pouch) found in an API container, with the investigation's scope being too narrow. Equipment cleaning and maintenance were found deficient, with rust-like materials and foreign particles present on "cleaned" manufacturing equipment used for multiple US-market APIs. The firm’s GMP training program was also critically lacking, showing numerous pending employee trainings and incomplete assessments, including untrained personnel handling customer complaints.

Furthermore, production operations failed to prevent API contamination due to out-of-limit differential pressures in manufacturing rooms during critical processes, with inadequate monitoring. The company also neglected to document and investigate deviations in product appearance observed during annual sample verifications. Finally, the inspection noted a failure to appropriately monitor water used in non-sterile API manufacturing steps for sterile drug products, specifically lacking endotoxin testing. Zydus Lifesciences Limited is required to address these serious deficiencies with comprehensive corrective and preventive actions to ensure product quality and regulatory compliance.