ISOThrive, Inc.June 30, 2023

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

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Record Details

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.

Company: ISOThrive, Inc.
Inspection Date: June 30, 2023
Product Type: Drugs
Office: Division of Human and Animal Food Operations - West V
Person: Rebecca T. Davis (investigator)

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ID · 16de3efd-38b2-4f48-895d-7bc8fa28dd8a