Stelli (603520.SH) issued an announcement. The company will run from September 2, 2024 to September 6, 2024...
Zhitong Finance App News, Sitaili (603520.SH) issued an announcement. The company underwent cGMP (Current Pharmaceutical Production Quality Management Specification) on-site inspection by the US Food and Drug Administration (hereinafter referred to as “FDA”) from September 2, 2024 to September 6, 2024. The scope of inspection covered six major systems: quality systems, materials, production, packaging and labeling, equipment and facilities, and laboratory control. Recently, the company received an on-site inspection report (EIR) issued by the US FDA. The report indicates that the company (factory area 1, Stary Avenue) has passed this cGMP on-site inspection.
This time, through an on-site inspection by the US FDA, it was shown that the company's No. 1 factory on Stelli Avenue complies with US FDA requirements in terms of drug cGMP quality management systems and production environment facilities, which provides a solid guarantee for the company to continue to expand the international market and has had a positive impact on expanding the global standardized market. At the same time, the company has established a hierarchical cGMP quality management system for R&D, production, quality control and project management in line with the world's leading industry standards, which has a positive effect on enhancing the company's overall competitiveness and future development.
