Issued to Curia New York, Inc.. Serious post-market compliance violation.
Issued
September 18, 2026Product
CGMP/Active Pharmaceutical Ingredient (API)/Adulterated
Company
Curia New York, Inc.
Review center
CDERStage
Final Decision
Assyro regulatory brief
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FDA issued a warning letter to Curia New York, Inc. concerning CGMP/Active Pharmaceutical Ingredient (API)/Adulterated. Deterministic full-text screening identifies discussion of Manufacturing and CGMP controls, Quality systems and CAPA, Data integrity and records, 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 September 18, 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.