FDA 483 - Ajanta Pharma Ltd. - April 21, 2026

An FDA inspection of Ajanta Pharma Ltd. in Paithan, India, revealed five significant observations concerning deficiencies in their quality control and manufacturing operations. The firm failed to adequately support drug product shelf-life with stability data, conduct thorough investigations into out-of-specification results, and maintain equipment properly. Additionally, the inspection found that written production procedures were not followed, and manufacturing equipment was not adequately qualified, indicating a lack of robust quality systems.