Steven J. Glass, MD – FDA EIR, Nov 1, 2013

An FDA inspection of CRI LifeTree LLC in Marlton, NJ, was conducted from September 25 to November 1, 2013, focusing on a clinical investigation involving an investigational drug for schizophrenia. The inspection was carried out under the Compliance Program Guidance Manual 7348.811 for Clinical Investigators. The inspection resulted in the issuance of a Form FDA 483, detailing significant observations. Key violations included the investigator's failure to adequately supervise the study, specifically by not routinely reviewing study records like case report forms, and being unaware of data entries made by sponsor employees. Furthermore, the investigator did not ensure adherence to standard operating procedures regarding the handling of investigational drugs by authorized personnel. CRI LifeTree LLC also failed to properly archive all study data, notably the case report forms, after the study's conclusion, violating protocol requirements. A critical finding was the investigator's failure to discontinue a study subject despite a clinically significant laboratory finding (elevated glucose). Management, represented by Dr. Glass, indicated a written response to the Form FDA 483 would be submitted within 15 working days to address these deficiencies and inform potential follow-up actions by the FDA.