FDA 483 - Jeffrey Mitchell Weinberg, MD - April 23, 2018

An FDA inspection of Jeffrey Mitchell Weinberg, MD, a clinical investigator in Forest Hills, NY, revealed significant non-compliance with investigational plans and data management. The firm failed to follow protocol-required procedures, such as conducting a serum pregnancy test and ensuring stable concomitant medication doses. Additionally, the site did not maintain adequate and accurate electronic case report forms, leading to missing data and incorrect subject stratification.