FDA 483 - Emcure Pharmaceuticals Limited - February 16, 2023

Emcure Pharmaceuticals Limited, a sterile drug manufacturer in Ahmedabad, India, was cited with five observations during an FDA inspection. The observations highlight significant deficiencies in environmental monitoring, aseptic process validation, quality unit oversight, computer system controls, and the scope of investigations for discrepancies and out-of-specification results. These issues indicate a lack of robust quality systems and controls for sterile drug manufacturing.