FDA 483 - Patel, Vikas V. - December 17, 2019

An FDA inspection of Vikas V. Patel, MD, Principal Investigator, in Aurora, CO, revealed significant deficiencies in the conduct of a clinical investigation. The firm failed to adhere to the investigational plan and FDA regulations, including issues with subject screening, incomplete pre-operative assessments, unperformed study procedures, and delayed adverse event reporting. Additionally, problems were noted with informed consent processes, premature promotion of an investigational device, and widespread inaccuracies and incompleteness in subject records and study correspondence.