Zhejiang Starry Pharmaceutical (603520.SH) passed the on-site inspection by the US FDA.

Zhejiang Starry Pharmaceutical (603520.SH) announced that the company underwent an on-site inspection by the U.S. Food and Drug Administration (FDA) for cGMP (current Good Manufacturing Practice) from September 2, 2024 to September 6, 2024. The inspection covered six major systems including quality system, materials, production, packaging and labeling, equipment facilities, and laboratory controls. Recently, the company received the Establishment Inspection Report (EIR) issued by the U.S. FDA, indicating that the company (Zhejiang Starry Pharmaceutical, No. 1 Grand Avenue) has passed the cGMP on-site inspection. The successful U.S. FDA inspection demonstrates that Zhejiang Starry Pharmaceutical, No. 1 Grand Avenue meets the requirements of the U.S. FDA for drug cGMP quality management system and production environment facilities, providing a solid guarantee for the company to expand in the international market and positively impacting the expansion of globally standardized markets. At the same time, the company has established a hierarchical cGMP quality management system that meets global high industry standards in research and development, production, quality control, and project management, playing a positive role in enhancing the company's overall competitiveness and future development.