Core Viewpoint - Huaxi Biological Technology Co., Ltd. has received a "zero defect" result from the FDA, indicating the highest level of compliance in its quality management system, which will enhance its global market competitiveness and facilitate overseas business expansion [1][2]. Group 1: FDA Audit and Certification - The FDA audit lasted five days and was conducted according to ICH Q7 guidelines, covering six major systems including quality systems and laboratory systems, confirming the company's meticulous management and commitment to quality [2]. - This is not the first time Huaxi Biological has received a "zero defect" recognition; it previously passed a similar audit by the Korean MFDS in February 2025 [2]. - The company has successfully passed five FDA audits, one PMDA audit in Japan, and two MFDS audits in Korea for its sodium hyaluronate raw materials [2]. Group 2: Global Market Position - Huaxi Biological has established a significant presence in the global market, holding 34 registration qualifications across various countries, including the EU, the US, Japan, and Korea, making it one of the suppliers with the most comprehensive registrations for pharmaceutical-grade sodium hyaluronate [2][4]. - The company has a marketing and supply chain network spanning over 70 countries and regions, with overseas subsidiaries in key markets such as the US, France, Japan, and South Korea [4]. Group 3: Product Development and Recognition - In addition to raw materials, Huaxi Biological has received global recognition in skin science innovation and medical devices, recently obtaining a medical device registration certificate from Brazil's ANVISA, known for its stringent regulatory standards [4]. - The company has accumulated over 70 medical device and skincare product registrations across more than 15 countries or regions [4]. Group 4: Long-term Strategy and Investment - Huaxi Biological emphasizes long-term research and development investment, maintaining high standards and a stable supply chain to build a strong foundation for quality products and brand development [5]. - The company follows a "technology breakthrough—quality control—global compliance—standard leadership" model, focusing on international standards and resource allocation to enhance its industrial capabilities and product standards [5].