智通财经APP讯，康龙化成(300759.SZ)公告，公司全资子公司康龙化成(绍兴)药业有限公司(简称“康龙绍兴”)于2025年5月29日至2025年6月4日接受了来自美国食品药品监督管理局(简称“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)，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。近日，康龙绍兴收到美国FDA出具的现场检查报告。该检查报告确认，康龙绍兴的生产设施顺利通过美国FDA的现场质量检查。根据该检查报告，康龙绍兴符合美国药品cGMP质量标准，通过了美国FDA认证。
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