Sewell, Michele M.D. – FDA Warning Letter, Aug 19, 2013

This Warning Letter details objectionable conditions observed during an FDA inspection of Michele A. Sewell, M.D.'s clinical site from June 17 to August 19, 2013, regarding two GlaxoSmithKline investigational drug protocols (GLP112754 and GLP112757) for albiglutide in Type 2 Diabetes Mellitus. The inspection, part of the Bioresearch Monitoring Program, found Dr. Sewell failed to adhere to statutory requirements and FDA regulations.

Key violations include: 1. **Failure to conduct the investigation according to the investigational plan [21 CFR 312.60]:** This involved enrolling ineligible subjects (e.g., incorrect sulfonylurea dose, presence of hemoglobinopathy affecting HbA1c), failing to report Serious Adverse Events (SAEs) promptly (e.g., 15-month delay for unstable angina), not adhering to dose increase criteria, missing protocol-required assessments (e.g., physical exams, ECGs, lab tests), and conducting study visits outside specified timeframes without justification. 2. **Failure to maintain adequate and accurate case histories [21 CFR 312.62(b)]:** Issues included changing the clinical significance of lab results (e.g., anemia) and the relationship of adverse events to the investigational product years later without documented rationale. 3. **