FDA 483 - Zydus Lifesciences Limited - January 19, 2026

An FDA inspection of Zydus Lifesciences Limited in Ankleshwar, India, revealed significant deficiencies in their manufacturing of active pharmaceutical ingredients. Observations included inadequate corrective and preventive actions for out-of-specification results, poor equipment maintenance and labeling, and incomplete laboratory records. These issues indicate a failure to ensure product quality and data integrity.