FDA 483 - Vijay M. Patel, M.D. - February 04, 2022

An FDA inspection of Vijay M. Patel, M.D., a clinical investigator, revealed significant deficiencies in the conduct of an investigational product study. The firm failed to maintain adequate records for dose preparation, did not conduct the investigation according to the signed plan, and exhibited a severe lack of oversight, leading to dosing errors and enrollment of ineligible subjects across multiple sites. Additionally, the firm failed to promptly report unanticipated problems and protocol deviations to the IRB.