FDA 483 - Zydus Lifesciences Limited - January 19, 2026

Zydus Lifesciences Limited in Ankleshwar, India, was cited for three observations during an FDA inspection. The firm failed to implement adequate corrective and preventive actions for out-of-specification investigations, maintained unsanitary and unlabeled manufacturing equipment, and did not maintain complete and accurate laboratory records. These issues indicate significant deficiencies in quality control and data integrity.