FDA WARNING_LETTER - Velmahos, George C. M.D., Ph.D - July 25, 2013

The FDA conducted an inspection of Dr. George C. Velmahos's clinical study, "(b)(4)," concluding on July 25, 2013, under the Bioresearch Monitoring Program. The inspection revealed multiple violations of regulations governing investigational new drugs (21 CFR Part 312 and Part 50). Key deficiencies included the failure to ensure the investigation was conducted according to the signed investigator statement and investigational plan, specifically citing incorrect dose administration to subjects and ordering (b)(4) prior to randomization without explanation. Informed consent was obtained by unauthorized physicians and, in one instance, was entirely missing, while in others, outdated consent forms were used. The letter also cited a failure to administer the investigational drug solely under the investigator's or a responsible subinvestigator's supervision, as personnel not on the Form FDA 1572 issued drug orders. Furthermore, Dr. Velmahos failed to maintain adequate and accurate case histories, with supporting data missing or not matching CRFs, inadequate source documentation (e.g., unattributable loose-leaf data, insufficient follow-up records), and missing subject weights. While some corrective actions proposed in Dr. Velmahos's August 2, 2013, response were deemed acceptable (e.g., personnel review, improved source documentation, weight recording, consent procedures), additional written responses and explanations were requested for several critical issues. Dr. Velmahos is required to provide documentation of corrective actions and prevent recurrence within fifteen business days, with a warning of potential regulatory action, including disqualification proceedings, if unaddressed.