FDA EIR - Arifulla Khan MD - June 11, 2014

An FDA inspection of Arifulla Khan, M.D., operating as Northwest Clinical Research Center in Bellevue, WA, was conducted from May 19 to June 11, 2014. This high-priority inspection, part of the CDER User Fee NDA Pre-Approval program, focused on clinical investigator data validation under Compliance Program 7348.811 for studies involving Duloxetine (NDA 021-427 S-043 and S-044), specifically protocols F1J-MC-HMGI and a related geriatric study. The previous inspection in 2013 was classified as Voluntary Action Indicated (VAI). The current inspection resulted in a Form FDA 483 detailing three main observations. Firstly, the investigation was not conducted in adherence to the signed statement of investigator and investigational plan, including issues with subject enrollment criteria and failure to discontinue a noncompliant subject. Secondly, there was a failure to obtain informed consent prior to drug administration and study-related procedures, specifically with one pediatric subject not using the most current IRB approved form. Thirdly, the site failed to prepare and maintain adequate and accurate case histories, evidenced by inaccurate Pediatric Anxiety Rating Scale (PARS) and other evaluations for a significant percentage of subjects. Additional issues discussed included contradictory diagnostic interviews, incomplete assessment checklists, a systemic failure to request medical history records, and delayed financial disclosure for a sub-investigator. Many of these issues echoed findings from prior inspections. In response, Dr. Khan committed to provide a written response to the observations within 15 business days and submitted letters explaining specific documentation discrepancies.