FDA 483 - Jon B. Cole, MD - April 26, 2019

This FDA Form 483 document outlines several significant violations observed during an inspection related to a clinical investigation involving an investigational new drug. The sponsor failed to submit an Investigational New Drug (IND) application to the FDA before initiating the clinical investigation, a fundamental regulatory requirement.

Furthermore, the inspection revealed that legally effective informed consent was not obtained from a subject or their legally authorized representative, and the situation did not meet the criteria for exception as outlined in 21 CFR 50.23 - 50.24. The investigation was also not conducted in accordance with the approved investigational plan.

Deficiencies were noted in the monitoring of the study, indicating a failure to ensure proper oversight. Investigational drug disposition records were found to be inadequate, specifically lacking sufficient detail regarding dates, quantity, and use by subjects. Finally, not all changes in research activity were approved by an Institutional Review Board (IRB) prior to their implementation, highlighting a lapse in adherence to ethical and regulatory protocols for study modifications. These findings indicate critical deficiencies in regulatory compliance, ethical conduct, and quality system management within the clinical investigation.