What happened
Original notice title
Prodrome Sciences USA, LLC MARCS-CMS 717959, January 08, 2026
From the archived source record
While we acknowledge the corrective and preventive actions you have taken and plan to take, your written response is inadequate because your corrective action plan did not include sufficient information to address how Prodrome Sciences, as a sponsor, will prevent similar violations in the future. Prodrome Sciences’ failure to submit, and to have in effect, an IND before initiating Protocol Pro-040-Plasm-01 with an investigational drug raises significant concerns about the safety and welfare of enrolled subjects, and raises concerns about the validity and integrity of the data collected during the conduct of this clinical investigation. 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 about 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
- 53f1e8d8ad00
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 →