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華熙生物(688363.SH):公司通過美國FDA現場檢查

格隆匯7月9日丨華熙生物(688363.SH)公佈,公司於2025年3月24日至2025年3月28日接受了美國食品藥品監督管理局(U.S.FoodandDrugAdministration,簡稱“FDA”)的cGMP(現行藥品生產質量管理規範)現場檢查,涵蓋質量體系、設施與設備、物料系統、生產系統、實驗室系統、包裝與標籤六大系統,檢查產品範圍爲玻璃酸鈉原料藥。近日,公司收到FDA出具的檢查報告(EstablishmentInspectionReport,簡稱“EIR”),公司以零缺陷(“0-483”)通過本次現場檢查。

此次是公司繼2012年首次參與美國FDA現場檢查以來,第五次通過FDA現場檢查,表明公司高質量生產製造規範持續獲得國際權威機構的認可。本次“零缺陷通過”爲FDA對藥品生產質量體系合規性的最高認可,標誌着公司質量管理體系達到國際高標準。該質量體系爲公司產品滿足國際法規要求提供可靠支持,有助於增強全球合作夥伴對公司產品合規性與質量的信心,爲拓展國際市場創造有利條件,進一步提升公司國際競爭力,對公司未來發展產生積極影響。

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