FDA record · warning letter

FDA warning letter: Chengdu Brilliant Biopharmaceutical Co., Ltd. (Sep 11, 2025)

On Sep 11, 2025, FDA issued a warning letter to Chengdu Brilliant Biopharmaceutical Co., Ltd. under the subject "CGMP/Finished Pharmaceuticals/Adulterated". It names semaglutide. 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 Chengdu Brilliant Biopharmaceutical Co., Ltd.
Field	What FDA’s record states	Source
Recipient	Chengdu Brilliant Biopharmaceutical Co., Ltd.	FDA letter
Location	Not published by FDA	n/a
Letter date	Sep 11, 2025	FDA letter
Posted by FDA	Sep 23, 2025	FDA index
Issuing office	Center for Drug Evaluation and Research (CDER)	FDA letter
Subject	CGMP/Finished Pharmaceuticals/Adulterated	FDA letter
MARCS-CMS number	711330	FDA letter
GLP-1 drugs named	Semaglutide	FDA letter
Response letter	Not published by FDA	FDA letter
Closeout letter	Not published by FDA	FDA letter

“Based on the records and information you provided, your firm has not conducted process validation for the Glucagon-Like Peptide-1 Receptor Agonist (GLP-1) API Semaglutide manufactured at your site. Process validation evaluates the soundness of design and state of control of a process throughout its lifecycle.”FDA warning letter to Chengdu Brilliant Biopharmaceutical Co., Ltd., Sep 11, 2025 · 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.

Other GLP-1 letters FDA issued that week

And 48 more in the full list.

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