Issued to Harbin Jixianglong Biotech Co., Ltd.. Serious post-market compliance violation.
Issued
May 1, 2026Product
CGMP/API/Adulterated and Misbranded Drugs
Company
Harbin Jixianglong Biotech Co., Ltd.
Review center
CDERStage
Final Decision
Assyro regulatory brief
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FDA issued a warning letter to Harbin Jixianglong Biotech Co., Ltd. concerning CGMP/API/Adulterated and Misbranded Drugs. Deterministic source-metadata screening identifies discussion of Manufacturing and CGMP controls, Labeling, claims, and misbranding. 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 1, 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.