FDA 483 - Vemulkonda Koneti Rao, M.D. - October 29, 2025

An FDA Form 483 was issued to Vemulkonda K. Rao, M.D., a Clinical Investigator, following an inspection conducted from October 20 to October 29, 2025, at the National Institutes of Health Clinical Center in Bethesda, MD. The inspection revealed that a clinical investigation was not conducted in accordance with the signed statement of investigator and investigational plan, as required by regulatory frameworks governing clinical trials. The primary observations detailed significant lapses in patient safety and data integrity.

Specifically, Dr. Rao failed to report numerous adverse events, including various infections (e.g., respiratory, COVID-19, C. difficile), halitosis, tooth extractions, headaches, and stomach pain, to the study sponsor for all five subjects reviewed. Furthermore, assessments of the seriousness, causality, and severity of these adverse events were not performed. The inspection also identified a failure to accurately report all concomitant medications, including antibiotics, for two out of the five subjects. These findings indicate a critical non-compliance with established clinical research protocols. As is customary with an FDA 483, the firm is expected to provide a comprehensive response outlining a plan for corrective actions to address these serious deficiencies and ensure future compliance.