FDA 483 - Vinay Sikand, M.D. - September 14, 2023

An FDA inspection of Vinay Sikand, M.D., a clinical investigator in Toms River, NJ, revealed significant deficiencies in the conduct of investigational drug studies. The firm was cited for inadequate record-keeping regarding investigational drug disposition and for failing to conduct investigations in accordance with approved plans. These issues indicate a lack of control over study materials and adherence to protocol requirements.