康龙化成子公司康龙绍兴通过美国FDA现场检查

Core Viewpoint - 康龙化成's subsidiary, 康龙化成(绍兴)药业有限公司, successfully passed the FDA's cGMP pre-approval inspection, confirming compliance with U.S. drug quality standards [1] Group 1: Company Overview - 康龙化成's subsidiary, 康龙化成(绍兴), underwent a cGMP pre-approval inspection by the FDA from May 29 to June 4, 2025 [1] - The inspection covered various GMP systems including quality management, material management, production management, equipment facilities, packaging and labeling, and laboratory control [1] - 康龙绍兴 received a positive on-site inspection report from the FDA, confirming that its production facilities met the required quality standards [1]