FDA 483 - Berman, Gary D., MD, Clinical Investigator - March 29, 2021

An FDA inspection of Berman, Gary D., MD, Clinical Investigator in Minneapolis, MN, revealed a significant issue regarding the conduct of investigations. The firm failed to adhere to the signed statement of investigator and investigational plan, specifically lacking an internal procedure for identifying, documenting, and resolving protocol deviations. This deficiency impacted the site's ability to manage eDiary entries and investigational product dose assignments.