Issued to Prime Sciences. Serious post-market compliance violation.
Issued
March 31, 2026Product
Unapproved New Drugs Sold Over the Internet
Company
Prime Sciences
Review center
CDERStage
Final Decision
Assyro regulatory brief
FreeSource facts and Assyro context are separated so you can scan the action quickly without treating analysis as an FDA conclusion.
FDA issued a warning letter to Prime Sciences concerning Unapproved New Drugs Sold Over the Internet. No controlled compliance theme met the deterministic text-matching threshold; review the exact FDA web letter and any later response or closeout.
Review the exact FDA warning letter, cited violations, requested corrections, and any later response or closeout before assessing current status.
Open the document workspaceFDA source document
FDA publishes this warning letter as a web document.
Open the exact FDA source to read the complete letter and verify its current response or closeout status.
Serious post-market compliance violation. Public notice requiring prompt remediation. FDA issued this letter on March 31, 2026.
The firm is expected to respond in writing, normally within 15 working days, describing corrective actions and timelines. FDA verifies remediation — often through reinspection — and issues a closeout letter when violations are corrected. Unresolved warning letters can escalate to import alerts, seizure, or injunction.