FDA 483 - XGen Pharmaceuticals DJB, Inc. - August 22, 2019

An FDA inspection of X-Gen Pharmaceuticals Inc.'s corporate office in Horseheads, NY, revealed significant deficiencies in their postmarketing adverse drug experience (PADE) reporting system. The firm lacked adequate written procedures for the surveillance, receipt, and evaluation of adverse drug experiences, and failed to submit required adverse drug experience reports and annual reports in a timely manner. These issues indicate a systemic failure to comply with PADE regulations.