Issued to Diasol, Inc.. Serious post-market compliance violation.
Issued
January 29, 2026Product
Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA)
Company
Diasol, Inc.
Review center
CDRHStage
Final Decision
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FDA issued a warning letter to Diasol, Inc. concerning Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA). Deterministic full-text screening identifies discussion of Quality systems and CAPA, Medical device quality and reporting, Labeling, claims, and misbranding, Laboratory controls and testing. 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 January 29, 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.