FDA 483 - Max Health, Subsero Health - March 04, 2022

Max Health, Subsero Health in Sarasota, FL, was cited for failing to submit an Investigational New Drug (IND) application to the FDA. The firm conducted a randomized, double-blinded, placebo-controlled outpatient clinical trial for COVID-19 without the required IND. This represents a significant regulatory non-compliance in the conduct of clinical investigations.