FDA 483 - Zydus Lifesciences Limited - January 23, 2026

During an inspection conducted from January 19-23, 2026, the U.S. Food and Drug Administration (FDA) issued a Form 483 to Zydus Lifesciences Limited, an active pharmaceutical ingredient (API) manufacturer located in Ankleshwar, Gujarat, India. The inspection revealed significant observations regarding the firm's quality management systems and operational controls. A primary concern was the failure to implement adequate corrective and preventive actions (CAPAs) following out-of-specification (OOS) investigations. Specifically, OOS results for impurities detected during stability studies were not effectively addressed. One proposed CAPA involved shortening product shelf life rather than resolving the root cause of impurity formation, effectively masking the quality issue. Another CAPA aimed to remove a process step identified as a cause, but lacked a validated alternative, failing to ensure compliant product manufacturing. Additional observations included deficiencies in equipment maintenance and identification. Equipment used in API manufacturing, such as a reactor, was found with apparent staining and lacked proper cleaning status designation. Rust was noted on other processing equipment, and product contact transfer hoses lacked essential identification labels. Furthermore, the firm failed to maintain complete and accurate laboratory records, specifically by using a digital scale without audit capabilities or printing capacity for subsample weights, with critical raw data subsequently discarded. These observations highlight deviations from expected quality standards for human and animal API manufacturing. Zydus Lifesciences Limited is required to respond to the FDA 483, detailing comprehensive corrective actions to address each identified deficiency and ensure future compliance.