Daniel C. Tarquinio, DO – FDA 483, Nov 5, 2021

Daniel Tarquinio, DO, a clinical investigator in Norcross, GA, received an FDA Form 483 citing significant deficiencies during an inspection. The observations included failures to conduct investigations according to the investigational plan, specifically regarding the enrollment of pediatric subjects in concurrent studies and incomplete safety analyses. Additionally, the firm's records for investigational drug disposition were found to be inadequate, lacking proper accountability for dispensed and returned product.