FDA EIR - Sasidhar P. Kilaru, M.D. - November 23, 2021

The FDA conducted a surveillance inspection of Clinical Investigator Sasidhar P. Kilaru, M.D., at the Linder Research Center in Cincinnati, OH, from October 25 to November 23, 2021. This initial inspection, performed under the regulatory framework of Compliance Program 7348.811 for Clinical Investigators and governing medical devices under sections 520(g) of the Federal Food, Drug, and Cosmetic Act, focused on Dr. Kilaru's conduct of a specific clinical study. The inspection revealed several main violations, documented in a Form FDA-483, List of Inspectional Observations. These included the failure to conduct the investigation according to the signed agreement and investigational plan. Specific issues identified were the enrollment and treatment of a subject who met exclusion criteria, the use of incorrectly sized devices for two subjects due to a lack of pre-randomization confirmation, delayed reporting of two serious adverse events outside protocol requirements, treating one subject with an unassigned device, and using devices for four subjects that did not meet protocol-specified length requirements. Dr. Kilaru acknowledged the observations and is required to submit a written response addressing these deficiencies within 15 business days.