Adam J. Wolff, M.D. – FDA 483, Dec 5, 2023

An FDA inspection of Adam Wolff, M.D. in Denver, CO, revealed significant deficiencies in the conduct of a clinical study. The firm failed to maintain adequate investigational drug disposition records, exhibiting numerous date and time discrepancies for investigational product preparation and administration. Additionally, the principal investigator did not adhere to the investigational plan, failed to maintain accurate source documents, and neglected to report a serious adverse event to the sponsor.