FDA record · warning letter

FDA warning letter: Harbin Jixianglong Biotech Co., Ltd. (May 1, 2026)

On May 1, 2026, FDA issued a warning letter to Harbin Jixianglong Biotech Co., Ltd. under the subject "CGMP/API/Adulterated and Misbranded Drugs". It names semaglutide, tirzepatide. Open: no closeout letter published as of Oct 3, 2026.

Julian CaraulaniFounder, PriceTracker GLP-1FDA record read Oct 3

Status: Open: no closeout letter published as of Oct 3, 2026.

What FDA’s record states

FDA record for the warning letter to Harbin Jixianglong Biotech Co., Ltd.
Field	What FDA’s record states	Source
Recipient	Harbin Jixianglong Biotech Co., Ltd.	FDA letter
Location	Not published by FDA	n/a
Letter date	May 1, 2026	FDA letter
Posted by FDA	May 19, 2026	FDA index
Issuing office	Center for Drug Evaluation and Research (CDER)	FDA letter
Subject	CGMP/API/Adulterated and Misbranded Drugs	FDA letter
MARCS-CMS number	723330	FDA letter
GLP-1 drugs named	Semaglutide, Tirzepatide	FDA letter
Response letter	Not published by FDA	FDA letter
Closeout letter	Not published by FDA	FDA letter

“In addition, we reviewed your firm’s drug listing submissions in FDA’s electronic Drug Registration and Listing System (eDRLS) and found that you failed to provide drug listing information for your relabeled semaglutide as required under section 510(j) of the FD&C Act, 21 U.S.C. 360(j), and 21 CFR Part 207.”FDA warning letter to Harbin Jixianglong Biotech Co., Ltd., May 1, 2026 · read the full letter on fda.gov ↗

What this is and is not.A warning letter is FDA’s statement of what it considers significant violations. It is an allegation, not a court finding, and the firm can respond. A closeout letter is posted when FDA confirms the violations were corrected.

Source

Every field above is copied from FDA’s page for this letter, read Oct 3, 2026. The letter on fda.gov ↗ · All 161 GLP-1 warning letters