FDA 483 - Jed C. Kaminetsky, M.D. - June 25, 2021

Jed C. Kaminetsky, M.D., a clinical investigator in New York, NY, was cited for failing to conduct an investigation in accordance with the signed statement of investigator and investigational plan. The inspection revealed significant issues including inadequate documentation of pharmacokinetic sample handling and processing, as well as numerous protocol deviations related to subject screening periods and study visit windows. These findings indicate a lack of adherence to established clinical trial procedures.