Issued to Asanuma Corporation - Sagamihara Factory. Serious post-market compliance violation.
Issued
June 2, 2026Product
CGMP/OTC Finished Pharmaceuticals/Adulterated
Company
Asanuma Corporation - Sagamihara Factory
Review center
CDERStage
Final Decision
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FDA issued a warning letter to Asanuma Corporation - Sagamihara Factory concerning CGMP/OTC Finished Pharmaceuticals/Adulterated. Deterministic source-metadata screening identifies discussion of Manufacturing and CGMP controls. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.
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Serious post-market compliance violation. Public notice requiring prompt remediation. FDA issued this letter on June 2, 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.