FDA 483 - Amneal Pharmaceuticals Private Limited - March 19, 2025

Amneal Pharmaceuticals Private Limited, a sterile drug manufacturer in Palli, Gujarat, India, was cited for significant deficiencies during an FDA inspection. The firm failed to thoroughly investigate product discrepancies, lacked adequate production and process control procedures, and exhibited poor laboratory control practices, including issues with Bacterial Endotoxin Testing. Additionally, the quality control unit failed to maintain proper oversight of document destruction.