FDA 483 - Manish Jain, M.D. - January 24, 2022

An FDA inspection of Manish Jain, M.D. revealed significant deficiencies in the conduct of a clinical investigation for a COVID-19 study. The firm failed to adhere to the investigational plan, resulting in incorrect investigational product dosing and improper informed consent procedures. Additionally, issues were noted with inadequate investigational drug disposition records and a failure to maintain accurate and complete case histories.