FDA EIR - Chakinala, Dr Murali M - April 29, 2013

The FDA conducted a Bioresearch Monitoring inspection of Clinical Investigator Murali M. Chakinala, M.D., located in Saint Louis, MO, from April 25 to April 29, 2013. This inspection was a high-priority, pre-approval data validation for New Drug Application (NDA) #204410, sponsored by Acetelion Pharmaceuticals, Ltd. The focus was on Protocol AC-055-302/SERAPHIN, a Phase III study investigating ACT-064992 for pulmonary arterial hypertension, conducted under the Bioresearch Monitoring Program, specifically CP 7348.811. The inspection meticulously reviewed various aspects of the study conduct, including administrative data, individual responsibilities, protocol adherence, Institutional Review Board (IRB) approvals, subject screening and enrollment, informed consent processes, and study drug handling. Records related to five screened and four enrolled subjects were examined, alongside source documents, case report forms, and adverse event reporting. The study drug accountability and temperature monitoring logs were also reviewed. The sponsor's monitoring activities were confirmed through visit logs and close-out letters. Significantly, the inspection concluded without identifying any deviations from regulatory requirements or the study protocol. Consequently, no FDA-483, Inspectional Observations, was issued to Dr. Chakinala. This indicates that the clinical investigator's site maintained compliance with applicable guidelines and good clinical practices during the conduct of this critical study. No specific corrective actions were required from the clinical investigator as a result of this inspection.