Reveragen Biopharma Inc. – FDA 483, Mar 6, 2023

An FDA inspection of Reveragen Biopharma Inc. in Rockville, MD, identified significant issues as a sponsor of a clinical study. Observations included the failure to address an investigator's non-compliance with investigational product retention protocols, leading to lost study medication without documented corrective actions. Additionally, the firm shipped investigational new drugs to an unauthorized individual not listed on the site's delegation log.