【康龙化成(03759.HK):康龙绍兴顺利通过美国FDA现场质量检查】智通财经APP讯,康龙化成(03759.HK)发布公告,公司全资附属公司康龙化成(绍兴)药业有限公司(康龙绍兴)于2025年5月29日至2025年6月4日接受了美国食品药品监督管理局(美国
FDA)的cGMP(现行药品生产质量管理规范)上市批准前检查(PAI)。本次检查范围涵盖质量体系、物料管理体系、生产管理体系、设备设施体系、包装和标签体系、实验室控制体系等各GMP系统。
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