Issued to Hubei Gedian Humanwell Pharmaceutical Co., Ltd.. Serious post-market compliance violation.
Issued
June 3, 2026Product
CGMP/Active Pharmaceutical Ingredient (API)/Adulterated
Company
Hubei Gedian Humanwell Pharmaceutical Co., Ltd.
Review center
CDERStage
Final Decision
Assyro regulatory brief
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FDA issued a warning letter to Hubei Gedian Humanwell Pharmaceutical Co., Ltd. concerning CGMP/Active Pharmaceutical Ingredient (API)/Adulterated. Deterministic full-text screening identifies discussion of Manufacturing and CGMP controls, Quality systems and CAPA, 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.
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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.