FDA 483 - James A. Simon, MD - May 05, 2023

During an FDA inspection conducted from May 2-5, 2023, James A. Simon, MD, a clinical investigator, received an FDA Form 483 detailing two significant observations. The first observation indicated that an investigation for a specific clinical study was not conducted in accordance with the signed agreement and investigational plan. This included instances where subject eligibility was not properly documented or assessed prior to randomization, such as a subject randomized without any documented inclusion/exclusion criteria assessment, another assessed criteria 22 days after randomization, and a third lacking a required baseline laboratory test before receiving investigational treatment. The second observation highlighted a lack of proper control over investigational devices, noting that a quantity of investigational products and specific treatment tips were not accurately accounted for in the disposition and return records. These observations, issued under the Federal Food, Drug and Cosmetic Act, suggest potential deviations from established protocols and regulatory expectations for clinical trial conduct and investigational product management. While the Form 483 itself is a list of observations, James A. Simon, MD, is expected to review these findings and implement appropriate corrective actions to ensure compliance with study protocols and regulatory requirements.