FDA 483 - Emcure Pharmaceuticals Limited - February 20, 2019

Emcure Pharmaceuticals Limited in Hinjwadi, India, was cited with six observations during an FDA inspection for manufacturing sterile and non-sterile drug products. The inspection revealed significant deficiencies in quality control, aseptic processing, environmental monitoring, laboratory procedures, and record-keeping, indicating a lack of thoroughness in investigations and adherence to established protocols. These issues collectively suggest a compromised state of control over sterile manufacturing operations and data integrity.