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

During an inspection from June 10-14, 2024, XGen Pharmaceuticals DJB, Inc. received an FDA Form 483 detailing four observations concerning its post-marketing adverse drug experience (ADE) reporting system. The primary issues included the absence of written procedures for accurately establishing the initial receipt date ("Day 0") for ADEs and for updating this date as complete information becomes available. Additionally, the inspection revealed deficiencies in Individual Case Safety Reports (ICSRs), specifically case ADV2020-014, which lacked crucial patient demographic information like age, gender, and weight. The company also failed to submit several non-serious safety reports electronically, instead providing them as physical attachments to periodic reports. Lastly, ICSRs derived from scientific literature incorrectly identified the contracted medical reviewer as the reporter, rather than the original author of the published article. These observations highlight a need for XGen Pharmaceuticals to enhance its pharmacovigilance procedures and ensure full compliance with adverse event reporting requirements under the Federal Food, Drug and Cosmetic Act.