Issued to Pharmathen International S.A.. Serious post-market compliance violation.
Issued
May 27, 2026Product
CGMP/Active Pharmaceutical Ingredient (API)/Adulterated
Company
Pharmathen International S.A.
Review center
CDERStage
Final Decision
Assyro regulatory brief
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FDA issued a warning letter to Pharmathen International S.A. concerning CGMP/Active Pharmaceutical Ingredient (API)/Adulterated. Deterministic full-text screening identifies discussion of Quality systems and CAPA, Manufacturing and CGMP controls, Laboratory controls and testing, Data integrity and records. 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 May 27, 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.