FDA 483 - Zydus Lifesciences Limited - August 13, 2025

During an inspection conducted from August 4-13, 2025, Zydus Lifesciences Limited, a drug products manufacturer, received an FDA Form 483 citing significant observations regarding its adherence to current Good Manufacturing Practices (cGMP). The inspection revealed deficiencies across several critical areas. The quality control unit failed to effectively manage product non-conformances, specifically concerning drug substance related impurities in a US product. This included a lack of Out-of-Specification (OOS) investigations, failure to analyze all impacted batches as committed, and the inappropriate adoption and communication of an unvalidated interim impurity limit to the FDA. The company also demonstrated inadequate procedures for handling complaints, notably failing to thoroughly investigate an adverse drug event involving a patient death due to insufficient data collection. Furthermore, a product mix-up complaint was not adequately investigated or linked to other related issues. Finally, the firm"s reserve sample program was found deficient, with visual examinations based on Acceptable Quality Levels (AQL) being insufficient to detect physical defects or count variabilities, leading to numerous customer complaints. These observations collectively indicate a systemic failure to maintain robust quality systems and highlight the necessity for Zydus Lifesciences Limited to implement comprehensive corrective and preventive actions to ensure patient safety and regulatory compliance.