From March 29 to April 3, 2025, Lujian CDMO platform—Sichuan Innovation Technology Co., Ltd.—underwent an FDA quality system audit conducted by the Israeli Ministry of Health in collaboration with the project partner Gordian. This audit represents a key step in Lujian’s international strategy, aiming to ensure that its medical device R&D, manufacturing, and service processes meet FDA’s stringent standards.
During the week-long audit, the Israeli Ministry of Health and Gordian audit team conducted a comprehensive and detailed inspection of Sichuan Innovation Technology’s key processes, including production workflows, quality control, and document management. The team visited production workshops, laboratories, and warehouses to perform a full evaluation of the company’s quality management system.
Sichuan Innovation Technology Co., Ltd. is an independent third-party CDMO innovation platform specializing in medical device R&D, manufacturing, and services, with laboratories located in Chengdu Economic and Technological Development Zone, Sichuan Province. The company is equipped with professional R&D and production facilities, including nearly 1,000 m² of ISO 7 (Class 10,000) production area and microbiological testing zones, capable of supporting various medical device R&D and production needs. The company has obtained ISO 13485 and ISO 11135 certifications and complies with GMP and FDA quality standards.
Passing the FDA quality system audit is not only a strong recognition of the quality management systems of Lujian and Sichuan Innovation Technology but also a solid step forward on the path to internationalization. We will continue to uphold the service philosophy of “from concept to compliant industrialized product launch,” providing domestic and international clients with higher-quality and more reliable medical device R&D and manufacturing services, promoting innovation in the medical device industry.
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