Zydus Lifesciences Limited – FDA 483, Jan 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.