科濟藥業-B(02171.HK):就FDA發現項提交整改報吿
格隆匯4月29日丨科濟藥業-B(02171.HK)發佈公吿,有關糾正和預防措施(CAPAs)計劃的整改報吿已提交給美國食品藥品管理局(FDA)。此次提交與2023年12月FDA對位於北卡羅來納州特勒姆的臨牀生產基地進行檢查後發佈的483表中的發現項有關。相關工作正按照此前遞交的時間線順利進行。公司承諾將與FDA密切合作,以質量為優先,確保臨牀試驗產品生產。
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