FDA 483 - Beth E. Safirstein, M.D. - June 05, 2023

Beth E. Safirstein, M.D., a clinical investigator in Hallandale Beach, FL, was cited for failing to conduct an investigation in accordance with the signed statement of investigator and investigational plan. This involved multiple temperature excursions for investigational products and serum samples. Consequently, 92 subjects received improperly stored investigational product and 9 subjects received improperly stored investigational product during a booster visit, without proper quarantine of the affected materials.