FDA 483 - P. Damodara Kumaran, M.D. - January 24, 2025

During an FDA inspection conducted from January 20-24, 2025, Clinical Investigator P. Damodara Kumaran, M.D., located in Pondicherry, Puducherry, India, received a Form FDA 483 outlining significant observations related to the conduct of a clinical investigation. The inspection revealed that the investigation was not carried out in accordance with the signed investigator statement and investigational plan. Specifically, subjects missed crucial weekly hematology safety laboratory tests, and post-study electrocardiograms were not performed as required by the protocol. Additionally, the FORM FDA 1572 lacked the necessary identification of study laboratories. A major concern was the failure to maintain adequate and accurate case histories. The firm did not retain complete laboratory results for two enrolled subjects, and the submitted laboratory data for four subjects contained inaccuracies. Furthermore, some lab results for one subject were reported twice with differing values, lacking clarity on the final accepted result. The method of submitting laboratory data via an Excel spreadsheet also raised issues, as it lacked documentation of who recorded the data, when it was recorded, and proper audit trails for any modifications. These observations indicate deficiencies in adhering to regulatory expectations for clinical study conduct and data integrity under the Federal Food, Drug, and Cosmetic Act. The firm is expected to respond to these observations with corrective actions.