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# Bioresearch Monitoring Issue at ISOThrive
- URL: https://www.fdaweb.com/bioresearch-monitoring-issue-at-isothrive/
- Published: 2025-02-12T12:00:00.000Z
- Updated: 2026-09-14T14:53:01.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5158648

A 6/26-6/30/2023 FDA Bioresearch Monitoring Program inspection at ISOThrive, Inc., in Healdsburg, CA, found objectionable conditions in its role as sponsor of two trials of an investigational drug. A 2/4 [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/isothrive-inc-688547-02042025?ref=fdaweb.com) says the specific issue was ISOThrive’s failure to submit an IND application for the conduct of clinical investigations with an investigational new drug.

FDA says the firm’s response to the form FDA-483 did not provide sufficient details of its corrective action plan for developing and implementing procedures to comply with IND regulations moving forward and thus FDA is unable to determine whether ISOThrive will comply with IND regulations in the future.