FDA 483 - Parag Kalyani, M.D. - July 01, 2024

An FDA inspection of Parag Kalyani, MBBS, MD, Clinical Investigator in Pune, India, identified significant failures in conducting a bioequivalence/bioavailability clinical study according to Good Clinical Practices. The inspection revealed widespread issues including inadequate case histories, numerous data discrepancies, missing and manipulated study documentation, and insufficient adverse event reporting. These findings raise serious concerns about the integrity and reliability of the clinical trial data.