FDA 483 - ISOThrive, Inc. - June 30, 2023

An FDA inspection of Isothrive Llc in Healdsburg, CA, identified a significant issue regarding the firm's role as a sponsor. The primary observation noted the failure to submit an Investigational New Drug (IND) application to the FDA prior to conducting clinical investigations with an investigational new drug. This indicates a serious lapse in regulatory compliance for drug development.