Issued to Ketamine Troche Store / www.ketaminetrochestore.com. Serious post-market compliance violation.
Issued
June 23, 2026Product
Unapproved New Drugs/Misbranded
Company
Ketamine Troche Store / www.ketaminetrochestore.com
Review center
CDERStage
Final Decision
Assyro regulatory brief
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FDA issued a warning letter to Ketamine Troche Store / www.ketaminetrochestore.com concerning Unapproved New Drugs/Misbranded. Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding, Manufacturing and CGMP controls, Unapproved products and premarket authorization. Topic matches are navigation aids, not a legal conclusion; 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.
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Serious post-market compliance violation. Public notice requiring prompt remediation. FDA issued this letter on June 23, 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.