FDA 483 - Aurobindo Pharma Ltd - July 21, 2023

An FDA inspection of Aurobindo Pharma Ltd in Medchal, Telangana, revealed three significant observations. These included a lack of validated equipment cleaning procedures, poor facility maintenance with a leaking ceiling in the quality control laboratory, and a failure to follow established laboratory control mechanisms, evidenced by contaminated test media. These issues indicate deficiencies in the firm's manufacturing and quality control processes.