FDA 483 - David L. Scott, MD - November 18, 2022

David L. Scott, MD, a clinical investigator in Laurelton, NY, was cited for significant deficiencies in conducting a clinical investigation and maintaining adequate records. The inspection revealed failures to properly implement corrective actions, report to the IRB promptly, adhere to data entry timelines, and accurately document adverse events and subject medications. These issues indicate a lack of adherence to the investigational plan and proper recordkeeping practices.