FDA 483 - Eric Hollander MD - October 20, 2020

An FDA inspection of Eric Hollander MD in Bronx, NY, revealed a significant issue regarding the conduct of an investigational plan. The firm failed to document phone call interviews and questionnaires used to evaluate patients for signs and symptoms of infection, affecting all six subjects in a study's Open Label Extension phase. This indicates a lack of adherence to study protocols and proper record-keeping.