Wire flash
Sinno Bio's unit Sinno Pharma placed on FDA import ban list
Editorial responsibility
- No named human review is recorded for this page.
- Source reporting is collected, normalized, translated or condensed automatically when needed.
- Automatically published source-backed update
Shengnuo Biotech (688117.SH) announced that its wholly-owned subsidiary, Chengdu Shengnuo Biopharmaceutical Co., Ltd. (Shengnuo Pharma), underwent an on-site inspection by the U.S. Food and Drug Administration (FDA) from August 20-22, August 24, and August 27, 2026. On August 27, the FDA issued a Form FDA 483 observation report citing 8 observations related to critical quality attribute identification, contamination control, detection and result reliability, and quality system governance for the same product group and production/packaging process. The company submitted an initial response and corrective measures via email to the FDA's CDER Office of Manufacturing Quality on September 17, 2026. As of now, Shengnuo Pharma has been listed on the FDA's Import Alert 66-40 as of September 19, 2026. However, the company has not yet received an Official Action Indicated (OAI) conclusion or a Warning Letter from the FDA beyond the Form FDA 483.
Source report
Sinoso Bio (688117.SH) announced that its wholly-owned subsidiary, Chengdu Sinoso Biopharmaceutical Co., Ltd. ("Sinoso Pharmaceutical"), underwent an on-site inspection by the U.S. Food and Drug Administration (FDA) from August 20 to August 22, August 24, and August 27, 2026.
On August 27, 2026, the FDA inspection team issued a Form FDA 483 (the "483") to the company, citing 8 observations under Section 704(b) of the U.S. Federal Food, Drug, and Cosmetic Act. The observations primarily relate to the same group of products and the same production and packaging processes, covering the following areas:
- Identification of critical quality attributes
- Contamination control capabilities
- Detection and result acceptance capabilities
- Quality system governance
On September 17, 2026, the company submitted an Initial Response and related corrective actions via email to the FDA's Center for Drug Evaluation and Research (CDER), Office of Manufacturing Quality (OMQ).
As of the latest inquiry on the FDA's official website, Sinoso Pharmaceutical was placed on Import Alert No. 66-40 on September 19, 2026. However, the company has not yet received an Official Action Indicated (OAI) conclusion or a Warning Letter from the FDA, aside from the Form FDA 483 already received.
Source
智通财经网Neutral / independent
Part of this Story
FDA import alert halts Shengnuo Biotech's US peptide API shipments, stock plunges 18.61%