FDA WARNING_LETTER - Gregory J.Tracey, M.D. - April 15, 2015

An FDA inspection conducted between March 25 and April 15, 2015, at Dr. Gregory J. Tracey's clinical site, as part of the Bioresearch Monitoring Program, revealed objectionable conditions. The inspection reviewed clinical investigations for Protocols (b)(4) and (b)(4). The FDA concluded that Dr. Tracey did not adhere to applicable statutory requirements and FDA regulations governing clinical investigations. Specifically, Dr. Tracey failed to ensure the investigation was conducted according to the investigational plan, as required by 21 CFR 312.60. This was evidenced by the enrollment of Subject 1214, a 22-year-old female, into Protocol (b)(4) despite multiple positive serum pregnancy tests at screening, rescreening, and check-in, which was contrary to the protocol's eligibility criteria. The subject subsequently received the investigational drug. Dr. Tracey's April 29, 2015, written response to the Form FDA 483 was deemed inadequate because the corrective action plan lacked sufficient detail regarding new laboratory procedures and steps to ensure appropriate review of reports and eligible subject enrollment. The FDA emphasized concerns about the protection of study subjects and the integrity of collected data. Dr. Tracey is required to notify the FDA within fifteen working days of actions taken to prevent similar violations, with failure to adequately address deficiencies potentially leading to further regulatory action.