採納股份(301122.SZ):美國FDA對子公司發出進口警示,稱其不符合器械質量體系要求
格隆匯4月7日丨採納股份(301122.SZ)公佈,近日關注到U.S.Food&DrugAdministration(美國食品藥品監督管理局,簡稱“FDA”)官網發佈的關於醫療器械的安全通訊,該通訊涉及對公司全資子公司江蘇採納醫療科技有限公司(簡稱“採納醫療”)出具的進口警示,FDA宣佈對江蘇採納醫療科技有限公司發出進口警示,稱其不符合器械質量體系要求,以防止塑料注射器產品進入美國”。該進口警示將導致採納醫療部分的醫療器械產品可以被美國海關執行不經檢查即扣留,致使部分醫用注射器產品暫時無法進入美國市場。
公司目前正通過律師與FDA方面保持積極溝通解決上述問題,但目前尚無法精準預計能否移出警示名錄以及移出的具體時間,在採納醫療未被移出上述名錄之前,採納醫療部分醫用注射器產品將暫時無法進入美國市場,預計對公司後續的主營業務收入和利潤產生重大影響。
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