FDA WARNING_LETTER - Buettner, Craig M., MD - May 06, 2009

An FDA inspection conducted between May 4 and 6, 2009, by Ms. Patricia Smith reviewed Dr. Craig M. Buettner's conduct of a clinical investigation for an investigational drug, protocol (b)(4). The inspection, part of the Bioresearch Monitoring Program, concluded that Dr. Buettner did not adhere to applicable statutory requirements and FDA regulations governing clinical investigations. A primary violation identified was the failure to ensure the investigation was conducted according to the investigational plan, specifically randomizing subjects postoperatively instead of preoperatively, in violation of 21 CFR 312.60. Despite receiving clarification from the monitor, this practice continued for several months. Additionally, Dr. Buettner failed to notify the Institutional Review Board (IRB) of this protocol deviation as soon as possible, as required by section 5.2 of the protocol, delaying notification by almost two years after the issue was identified. The FDA found the submitted corrective action plan inadequate, lacking specific details to prevent recurrence. Dr. Buettner is required to notify the FDA in writing within fifteen working days of the actions taken to prevent similar violations in the future, with failure to do so potentially resulting in regulatory action.