What happened
Original notice title
ISOThrive, Inc. MARCS-CMS 688547, February 04, 2025
From the archived source record
ISOThrive’s failure to submit, and to have in effect, an IND before initiating clinical investigations with an investigational drug raises significant concerns regarding the safety and welfare of enrolled subjects, and raises concerns about the validity and integrity of data collected during the conduct of these clinical investigations. Within 15 business days of your receipt of this letter, you should notify this office in writing of the actions you have taken to prevent similar violations in the future. Failure to address this matter adequately may lead to regulatory action. Should you have any questions or concerns regarding this letter or the inspection, please email FDA at CDER-OSI-Communications@fda.hhs.gov.
What the official notice says to do
Check the original notice for the instructions that apply to the named product, company, and affected lots.
Read the official notice →Status and source details
- Status recorded in the archive
- No closeout listed in FDA table
- Source checked
- Jul 16, 2026
- Record revision
- feffc51e854a
This is a dated record. Its current status may have changed since the source was captured. A record applies to its stated scope; it is not a safety rating for every product from a company.
Sources, dates, and coverage →