Max Health, Subsero HealthMarch 4, 2022

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

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Record Details

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.

Company: Max Health, Subsero Health
Inspection Date: March 4, 2022
Product Type: Drugs
Office: Office of Medical Device and Radiological Health Division II
Person: Ladislav Kermet (issuing_officer)

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ID · 3b17b944-9d93-4525-b97f-819229496fb4