As golden September unfolds, Xieli Group is celebrating two momentous joys: with the National Day and Mid-Autumn Festival approaching, the Group’s core product lines have passed the U.S. FDA on-site inspection with "zero deficiencies" from September 22 to 26. This milestone achievement not only places Xieli Group among the global elite in quality management and international compliance but also stands as a heartfelt tribute to the upcoming festivals—epitomizing the striving spirit of "Unite as one".
The U.S. FDA is one of the world’s most rigorous pharmaceutical regulatory authorities. During the inspection, FDA inspector conducted in-depth review of six key systems – quality system, facilities and equipment, material system, production system, quality control system, and packaging& labeling. The inspector also carried out comprehensive checks on critical aspects such as the compliance of production facilities, data integrity, and the completeness of the quality system. The smooth clearance of this certification inspection signifies that every link of product lifecycle, from raw material procurement to finished product delivery, meets the world-class quality control standards. It also demonstrates that the company has obtained FDA recognition for its pharmaceutical production process control, quality management system, and compliance, fully validating the enterprise’s outstanding capabilities in the refined control of quality management. Throughout the inspection, Xieli employees demonstrated a high level of professionalism and a rigorous work attitude, earning high praise from the FDA inspector.
Behind this certification glory lies Xieli Group’s dedicated practice in the pharmaceutical field since its establishment, with "Unite as one" as the soul of its development. To meet international high standards, the Group has pooled the strengths of all teams, including R&D, production, quality assurance, compliance, and logistics. It has invested heavily in building FDA-standard GMP workshops, established a collaborative management system covering raw material traceability to finished product tracking, and set up multiple key quality control points. Every link reflects the collaborative spirit of "sound leadership and effective implementation".
From preparation to on-site inspection, all departments worked in unison as a cohesive force. Professional teams and frontline employees worked day and night to successfully complete the on-site inspection process. At the celebration, the Group’s Chairman emotionally stated, "This achievement belongs to every Xieli employee; it is the best interpretation of our corporate vision of ‘co-creating glory’."
The successful FDA certification not only opens the door for Xieli’s products to enter the U.S. market but also serves as a "passport" for accessing major global pharmaceutical markets such as the European Union and Japan, laying a solid foundation for the company to further expand its international market presence. It is expected that in the next three years, the proportion of XL Pharmaceutical’s overseas sales will rise to over 70%.
Amid the double joy of the successful FDA on-site inspection and the dual festivals, Xxieli Group not only organized an employee celebration but also recognized and rewarded outstanding individuals for their contributions.
Taking this opportunity, the company will always prioritize product quality. It will introduce advanced production equipment and technologies, establish a more robust quality management system, cultivate a high-quality and professional production and management team, and continuously improve production efficiency and product quality to provide strong support for the company’s development. In the future, the company will continue to uphold the development philosophy of "Quality First, Innovation-Driven", actively expand the international market, strengthen cooperation and exchanges with international pharmaceutical enterprises, continuously enhance its brand influence and market competitiveness, and contribute to the development of the global pharmaceutical industry.
"FDA certification is a new starting point, and the dual festival celebration is a new driving force," emphasized the Group’s Chairman in his speech. "In the future, we will continue to gather development momentum with ‘unity for synergy’ and write a new chapter of the era with ‘co-creating glory’. We will keep moving forward on the path of ‘XL Jointly Building a Healthy Cause’. At the same time, we wish our motherland prosperity and strength, and every employee a happy festival and a harmonious family!"
