Issued to Tianjin Kilo Pharmaceutical Sci-tech Co., Ltd.. Serious post-market compliance violation.
Issued
August 6, 2026Product
CGMP/Active Pharmaceutical Ingredient (API)/Adulterated/Misbranded
Company
Tianjin Kilo Pharmaceutical Sci-tech Co., Ltd.
Review center
CDERStage
Final Decision
Assyro regulatory brief
FreeSource facts and Assyro context are separated so you can scan the action quickly without treating analysis as an FDA conclusion.
FDA issued a warning letter to Tianjin Kilo Pharmaceutical Sci-tech Co., Ltd. concerning CGMP/Active Pharmaceutical Ingredient (API)/Adulterated/Misbranded. Deterministic full-text screening identifies discussion of Manufacturing and CGMP controls, Labeling, claims, and misbranding, Laboratory controls and testing, Quality systems and CAPA. 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.
Open the document workspaceFDA source document
FDA publishes this warning letter as a web document.
Open the exact FDA source to read the complete letter and verify its current response or closeout status.
Serious post-market compliance violation. Public notice requiring prompt remediation. FDA issued this letter on August 6, 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.