FDA 483 - Jed C. Kaminetsky, M.D. - December 07, 2022

Jed C. Kaminetsky, M.D., a clinical investigator in New York, NY, was inspected by the FDA. The inspection revealed a significant failure to conduct an investigation in accordance with the signed statement of investigator and investigational plan. Specifically, the investigator did not follow protocol requirements for urine cytology procedures for multiple enrolled subjects.