FDA 483 - Steven J. Glass, MD - November 01, 2013

CRI LifeTree LLC, located in Marlton, NJ, underwent an FDA establishment inspection from September 25, 2013, to November 1, 2013. This inspection, conducted under Compliance Program Guidance Manual 7348.811 for Clinical Investigators, focused on a Phase 1 clinical study of an investigational drug for schizophrenic patients. The inspection identified several significant issues, resulting in the issuance of an FDA Form 483. Key observations included inadequate supervision by the Principal Investigator, Dr. Steven J. Glass, who did not routinely review study records and was unaware that sponsor employees were entering data into electronic case report forms (eCRFs). The firm also showed deficiencies in investigational drug accountability, with missing dispensing documentation and inaccurate logs that prevented a complete reconciliation. Additionally, a study subject was not discontinued despite a clinically significant laboratory finding, contrary to protocol requirements. Crucially, CRI LifeTree LLC failed to archive all study data, specifically the eCRFs, following the study's conclusion. At the inspection's close, Dr. Glass was informed that a written response addressing these observations was required within 15 working days for the USFDA to consider it for any follow-up actions.