Junye Pharmaceutical passed the FDA on-site audit with "zero defects" and its quality strength was once again internationally recognized.

2025-09-18 14:30:29

In July 2025, the U.S. Food and Drug Administration (FDA) conducted a five-day on-site audit of Junye Pharmaceutical, and the company successfully passed the audit with "zero defects".

This FDA audit is strictly based on compliance plan 7356.002F, namely the "Active Pharmaceutical Ingredient Manufacturing Inspection Guide" and "ICH-Q7 Guide", comprehensively covering the four systems of quality, production, facilities and equipment, and raw and auxiliary materials. During the audit process, the company team relied on its solid professionalism and efficient collaboration capabilities to conduct a comprehensive display and in-depth exchange of views on the company's quality management system, product production process, quality control and other aspects in strict accordance with FDA audit requirements. At the final audit summary meeting, the FDA inspector highly affirmed Junye Pharmaceutical's GMP quality management system. It is worth mentioning that this is the third time that Junye Pharmaceutical has passed the US FDA audit, and has achieved "zero defect" twice in a row.

Passing the FDA audit with "zero defects" is not only a phased achievement, but also the starting point of a new journey. Junye Pharmaceutical will continue to uphold international advanced quality standards, implement quality management covering the entire product life cycle, continuously consolidate "Junye quality" with high standards and strict execution, and continue to provide customers with high-quality products. The successful passing of this FDA audit will further consolidate the company's business foundation in the international market and inject strong impetus into expanding global cooperation.