FDA 483 - Vijay Swarup MD - May 30, 2025

During an inspection conducted from May 20 to May 30, 2025, the U.S. Food and Drug Administration (FDA) issued a Form 483 to Vijendra Swarup, MD, identifying two significant observations regarding the conduct of a clinical investigation. The first observation cited a failure to promptly report serious adverse events (SAEs) to the study sponsor. Specifically, documented instances showed substantial delays in reporting, with one SAE of diarrhea reported nearly a year after awareness, and another injury SAE reported several months late. Regulatory guidelines mandate timely reporting of such events to ensure subject safety and data integrity. The second observation concerned the non-adherence to the investigational plan. The protocol required all screening laboratory abnormalities to be judged for non-clinical significance before patient randomization. However, the FDA observed multiple instances where subjects were randomized into the study before their screening lab results received the necessary sign-off by the investigator or staff. This constitutes a deviation from the established study procedures. These observations, issued under the Federal Food, Drug and Cosmetic Act, highlight potential deficiencies in the firm's clinical trial oversight and regulatory compliance. Vijendra Swarup, MD, is expected to address these findings by developing and implementing corrective and preventive actions to ensure compliance with federal regulations and the study protocol, thereby safeguarding human subjects and the integrity of clinical data.