FDA WARNING_LETTER - Chengdu Brilliant Biopharmaceutical Co., Ltd.

On September 11, 2025, the FDA issued a Warning Letter to Chengdu Brilliant Biopharmaceutical Co., Ltd., an active pharmaceutical ingredient (API) manufacturer in China. This action followed a review of company records submitted in response to a March 12, 2025, request under the Federal Food, Drug, and Cosmetic Act.

The FDA identified significant deviations from Current Good Manufacturing Practice (CGMP) for APIs, leading to the classification of the company"s drugs, including Semaglutide, as adulterated. The primary violations included a failure to adequately validate manufacturing processes, meaning the company could not consistently demonstrate its ability to produce APIs meeting quality attributes. Additionally, the company failed to conduct identity testing for each batch of incoming production materials, lacking scientific evidence that raw materials met specifications before use.

To rectify these issues, Chengdu Brilliant Biopharmaceutical Co., Ltd. must submit a detailed summary of its validation program, including timelines for process performance qualification and procedures for equipment and facility qualification. The FDA also requires a comprehensive, independent review of the material system to ensure supplier qualification, proper material dating, and robust incoming material controls. A commitment to performing specific identity tests for all incoming component lots is also mandated. The company’s drugs are currently under Import Alert 66-40, and a written response detailing corrective actions is required within 15 working days.