FDA WARNING_LETTER - Devalingam Mahalingam, M.D., Ph.D. - October 18, 2024

This FDA Warning Letter, dated December 11, 2025, was issued to Devalingam Mahalingam, M.D., Ph.D., following an inspection conducted from October 7 to October 18, 2024. The inspection identified serious objectionable conditions during clinical investigations. The primary violation cited was a failure to ensure the investigation adhered to the investigational plan, specifically in a protocol for an investigational drug. A critical error occurred where a subject received approximately 100 times the intended dose of the investigational drug due to incorrect dilution during preparation. This severe dosing error led to the subject experiencing multiple serious adverse events, including cardiac arrest and subsequent death. The regulatory framework violated includes the Federal Food, Drug, and Cosmetic Act and regulations in 21 CFR Part 312, which mandate proper conduct of clinical investigations and protection of human subjects. Although Dr. Mahalingam submitted a response with corrective actions such as staff training and updated procedures, the FDA deemed it inadequate. The response lacked sufficient detail on how Dr. Mahalingam, as the clinical investigator, would ensure comprehensive oversight to prevent similar future violations. Dr. Mahalingam is required to provide a written response within 15 business days, outlining specific and adequate actions to prevent recurrence of these violations, or face potential further regulatory action.