FDA 483 - Emcure Pharmaceuticals Limited - May 15, 2026

An FDA inspection of Emcure Pharmaceuticals Limited in Ahmedabad, India, revealed significant deficiencies in their drug manufacturing operations. The firm failed to adequately qualify equipment, thoroughly investigate product complaints, and maintain proper laboratory controls for raw materials. Critical issues were also identified in aseptic processing validation and contamination prevention for sterile drug products, alongside inadequate controls over computer systems and data integrity.