FDA 483 - Marc A. Bjurlin, D.O. - July 22, 2024

During an inspection conducted from July 15 to July 22, 2024, the Food and Drug Administration (FDA) issued a Form 483 to Clinical Investigator Marc A. Bjurlin, D.O., operating at UNC Hospitals Urology Clinic in Chapel Hill, NC. The inspection identified a significant deviation from regulatory expectations concerning the conduct of a specific clinical study, Protocol Study (b)(4). The primary observation noted was that the investigation was not carried out in accordance with the agreed-upon study protocol and the investigator's commitments. Specifically, the FDA found that essential, protocol-required imaging assessments for enrolled subjects were not performed. These missed assessments included two distinct imaging procedures, as outlined in Section 9.1.4.1. of the study protocol. This represents a failure to adhere to the established investigational plan. The FDA 483 document serves as a record of these inspectional observations, highlighting areas where the clinical trial conduct did not meet federal regulations. While not a final determination of compliance, it requires the investigator to consider corrective actions or provide a response addressing these deficiencies to ensure the ethical and scientific rigor of ongoing and future clinical research.