FDA 483 - Zydus Lifesciences Limited - April 25, 2025

Zydus Lifesciences Limited in Dabhasa, India, received a Form 483 following an inspection of its API manufacturing facility, revealing significant deficiencies. Issues included inadequate complaint investigations, insanitary equipment, widespread GMP training failures, and insufficient contamination control measures. The firm also failed to document deviations and properly monitor water quality for sterile drug product APIs.