Chengdu Sheng Nuo Biotec Co., Ltd. (688117.SH) announced that its wholly-owned subsidiary, Chengdu Sheng Nuo Pharmaceutical Co., Ltd., underwent on-site inspections by the U.S. Food and Drug Administration (FDA) on August 20-22, August 24, and August 27, 2026. During the final inspection day, the FDA issued a Form FDA 483 observation report citing eight specific observations under Section 704(b) of the U.S. Federal Food, Drug, and Cosmetic Act.

The observations focused on the same product group and the same production and packaging process, highlighting issues in critical quality attribute identification, contamination control capabilities, detection and result acceptance capabilities, and quality system governance. The company submitted its initial response and related corrective actions via email to the FDA's Center for Drug Evaluation and Research (CDER) Office of Manufacturing Quality (OMQ) on September 17, 2026.

As of now, the FDA's official website confirms that the subsidiary was added to the Import Alert 66-40 list on September 19, 2026. However, aside from the received Form FDA 483, the company has not yet received an Official Action Indicated (OAI) conclusion from the FDA, nor has it received a Warning Letter from the agency.