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

Source: https://www.keypedia.com/records/483/isothrive-inc/16de3efd-38b2-4f48-895d-7bc8fa28dd8a

> FDA 483 for ISOThrive, Inc. on June 30, 2023. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: ISOThrive, Inc.
- Inspection Date: 2023-06-30
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - West V
- Summary: 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.

## Related Officers

- [investigator](https://www.keypedia.com/people/rebecca-t-davis/a821f7ef-0c73-4be1-9a9b-3fc2c07f88c1)

Company: https://www.keypedia.com/companies/isothrive-inc/0dc4f3dc-0608-4edd-9a51-7d283fa42e06

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-west-v/0f4dd01e-8e8a-4336-9abe-ce8b3d309e8b