FDA 483 - Laura Mulloy, D.O. - September 11, 2019

An FDA inspection of Dr. Laura L. Mulloy, D.O., a clinical investigator in Augusta, GA, revealed two significant issues. The firm's investigational drug disposition records were inadequate, leading to discrepancies in drug accountability and an inability to verify administered dosages. Additionally, the inspection found multiple instances where informed consent was not obtained from human subjects prior to performing study-related tests.