Issued to BlephEx, LLC. Serious post-market compliance violation.
Issued
June 3, 2026Product
Medical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k)
Company
BlephEx, LLC
Review center
CDRHStage
Final Decision
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FDA issued a warning letter to BlephEx, LLC concerning Medical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k). Deterministic full-text screening identifies discussion of Quality systems and CAPA, Labeling, claims, and misbranding, Medical device quality and reporting, 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 3, 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.