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Chengdu Brilliant Biopharmaceutical Co., Ltd., a Chinese manufacturer of active pharmaceutical ingredients (APIs), failed to demonstrate that its manufacturing process for Semaglutide (a Glucagon-Like Peptide-1 Receptor Agonist) could reproducibly produce APIs meeting predetermined quality attributes. The company had not conducted required process validation for this drug product, representing a significant deviation from Current Good Manufacturing Practice (CGMP) standards. These compliance failures meant the firm's APIs were considered adulterated under the Federal Food, Drug, and Cosmetic Act, prompting the warning letter issued by FDA's Center for Drug Evaluation and Research.