Chengdu Brilliant Biopharmaceutical Co., Ltd.

you failed to conduct an identity test on the raw materials used for manufacturing of your API during (b)(4), e.g., (b)(4).

your firm has not conducted process validation for the Glucagon-Like Peptide-1 Receptor Agonist (GLP-1) API Semaglutide manufactured at your site.

FDA placed all drugs and drug products offered for import into the United States from your firm on Import Alert 66-40 on July 9, 2025.

After you receive this letter, respond to this office in writing within 15 working days. Specify what you have done to address any deviations and to prevent their recurrence.

FDA may withhold approval of new applications or supplements listing your firm as a drug manufacturer until any deviations are completely addressed and we confirm your compliance with CGMP. We may inspect to verify that you have completed corrective actions to any deviations.

Failure to address any deviations may also result in the FDA continuing to refuse admission of articles manufactured at Chengdu Brilliant Biopharmaceutical Co., Ltd., FEI 3015530591, at #33, Tengfei 12th Road, Southwest Airport Economic Dev Zn, Shuangliu District Chengdu into the United States under section 801(a)(3) of the FD&C Act, 21 U.S.C. 381(a)(3).