FDA EIR - Sreedhar Samudrala - March 28, 2013

An FDA inspection of Sreedhar Samudrala, a clinical investigator in Franklin, TN, was conducted from March 12 to March 28, 2013. This for-cause inspection, performed under Compliance Program 7348.811, Bioresearch Monitoring, uncovered significant regulatory violations across two clinical studies.

The primary issues included failures to adhere to legal and procedural requirements. Five subjects were assigned study numbers before obtaining legally effective informed consent, a direct violation of 21 CFR 50.20. Additionally, the investigation did not follow the established investigational plan as required by 21 CFR 312.60. This was evident as nineteen subjects were enrolled without meeting critical inclusion/exclusion criteria, and eleven subjects were randomized before completing all mandatory baseline procedures.

The inspection also identified pervasive record-keeping deficiencies, such as using photocopied signatures, improperly altering dates, incomplete logging of concomitant medications, and inconsistencies between electronic and paper records. Drug accountability documentation was also problematic. Furthermore, the Institutional Review Board (IRB) was not adequately notified of all participating sub-investigators and study locations, impacting oversight.

Following the issuance of an FDA 483 form outlining these observations, Dr. Samudrala and management were advised to submit a formal written response within 15 days. They committed to implementing corrective actions, including retraining staff on proper informed consent, record-keeping practices, and ensuring comprehensive communication with the IRB regarding all study modifications.