Shanhe Pharmaceutical Passes FDA Inspection

Shanhe Pharmaceutical announced that it underwent an on-site inspection by the U.S. Food and Drug Administration (FDA) from December 4 to December 5, 2025. According to Jin10, the inspection covered six major systems: quality management, production management, facilities and equipment management, laboratory quality control, and materials and packaging label management. The company received an Establishment Inspection Report (EIR) from the FDA, confirming the successful completion of the inspection.