FDA WARNING_LETTER - Agnes E. Ubani, MD - June 06, 2013

The FDA issued a Warning Letter to Dr. Agnes Ubani of Windsor Medical Clinic following an inspection conducted from May 29 to June 6, 2013. The inspection, part of the Bioresearch Monitoring Program, reviewed Dr. Ubani's conduct of two clinical investigations: Protocol 1245.25 for Boehringer Ingelheim Pharmaceuticals, Inc. and Protocol H9X-MC-GBDN for Eli Lilly and Company. The FDA concluded that Dr. Ubani failed to adhere to applicable statutory requirements and FDA regulations governing clinical investigations. Two primary violations were identified. First, Dr. Ubani failed to ensure the investigation was conducted according to the investigational plan [21 CFR 312.60], specifically by enrolling subjects who did not meet inclusion/exclusion criteria for Protocol 1245.25, including those with a history of cancer, lacking high cardiovascular risk, or having uncontrolled hyperglycemia. This affected 50% of enrolled subjects in that protocol, jeopardizing subject safety and data validity. The corrective action plan for eligibility screening was deemed inadequate due to lack of detail. Second, Dr. Ubani failed to maintain adequate and accurate case histories [21 CFR 312.62(b)], evidenced by discrepancies in signature dates on laboratory reports, raising concerns about data validity and integrity. The proposed corrective action for case histories was also deemed inadequate. Dr. Ubani must address these deficiencies and establish procedures for future compliance. A written response detailing corrective actions is required within fifteen working days to prevent further regulatory action.