i.aspCDMO Platform Successfully Passes FDA Quality System Audit
From March 29 to April 3, 2025, the CDMO platform of Sichuan Innovation, under Lujian Technology, underwent an FDA quality system audit conducted by the Israeli Ministry of Health in collaboration with international partners. This audit marks a significant step in Lujian Technology’s internationalization strategy, aimed at ensuring that its medical device research, development, production, and service processes comply with the stringent standards set by the FDA.
During the one-week audit, the audit team from the Israeli Ministry of Health and international partners conducted a comprehensive and detailed review of key processes, including production workflows, quality control, and documentation. The team visited production workshops, laboratories, and warehouses, thoroughly assessing the company’s quality management system.
Following a rigorous audit process, Lujian Technology successfully passed the FDA quality system audit, demonstrating its well-established quality management system and standardized operational procedures. This achievement signifies that the CDMO platform's quality management in medical device R&D, manufacturing, and services has reached internationally advanced standards, laying a solid foundation for its products to enter international markets.
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