FDA 483 - XGen Pharmaceuticals DJB, Inc. - June 14, 2024

An FDA inspection of XGen Pharmaceuticals DJB, Inc. in Horseheads, NY, revealed significant deficiencies in their handling and reporting of post-marketing adverse drug experiences. Observations included a lack of written procedures for initial receipt dates, incomplete patient information in Individual Case Safety Reports (ICSRs), and failures to submit safety reports electronically. Additionally, the firm incorrectly identified reporters in expedited ICSRs from scientific literature.