FDA 483 - Emcure Pharmaceuticals Limited - April 05, 2024

Emcure Pharmaceuticals Limited in Charal, Gujarat, India, was inspected from March 28 to April 5, 2024. The inspection revealed one observation concerning the firm's failure to establish and follow procedures for instrument calibration and preventive maintenance for microbiological testing equipment. This issue impacts the reliability and accuracy of microbiological test results, as the firm relies solely on vendor qualification.