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賽升藥業(300485.SZ)控股子公司收到行政處罰
格隆匯 12-01 18:09

格隆匯12月1日丨 賽升藥業(300485.SZ)公佈,公司近日收到控股子公司北京賽而生物藥業有限公司(以下簡稱"子公司"或"賽而生物")的報告,該公司收到北京市市場監督管理局出具的《行政處罰決定書》(京市監食罰字[2019]24號)。

行政處罰主要內容:

(一)因賽而生物生產的賽而牌天葡片(批號:20190601;生產日期2019-06-11)鉛項目不符合產品包裝標示執行的企業標準,故違反了《中華人民共和國食品安全法》第七十八條規定,屬於生產標籤、説明書不符食品安全法規定。

(二)賽而生物違反了《中國人民共和國食品安全法》第五十條第一款的規定,屬於進貨時未查驗許可證規定。依據《中華人民共和國食品安全法》第一百二十五條第一款第(二)項,第一百二十六條第一款第(三)項的規定,賽而生物生產的不合格產品貨值金額在一萬元以下,決定給與行政處罰:1.警告;2.沒收違法所得七千一百二十元;3.沒收違法生產經營的食品賽而牌天葡片(批號:20190601;生產日期2019-06-11)418盒;4.處罰五萬元;罰款合計五萬七千一百二十元。

採取的措施:

賽而生物在獲悉相關事件後,立即展開調查,將該批產品生產所用原料送第三方進行鉛外檢,檢驗結果發現刺五加提取物(批號190405)鉛超標,初步判定該批產品鉛超標原因為刺五加提取物鉛超標所致。賽而生物已對該批次問題原料進行了無害化處理。

調查20190601賽而牌天葡片的生產過程符合要求。按照註冊和備案的工藝和配方組織生產,產品的生產工藝與技術要求或申報的配方工藝一致,該批產品的批生產記錄能客觀真實體現生產全過程,並與生產工藝規程要求一致。出廠檢驗符合產品的企業標準。因出廠檢驗項目中不含鉛檢驗項目,所以該批次成品鉛超標未及時發現。但賽而牌天葡片成品每年型式檢驗為全項檢驗,包含鉛檢驗項目,之前賽而生物每年均委託第三方進行型式檢驗,結果均未出現不合格情況。

查閲賽而生物賽而牌天葡片近三年北京市和國家監督抽檢情況,均未出現不合格。本批生產使用刺五加提取物,有隨貨的檢驗合格報告單(含有重金屬檢驗項目,合格),賽而生物對該批物料的入廠檢驗合格,由於入廠檢驗不含鉛檢驗項目,所以導致鉛含量超標未及時發現,影響該批產品質量。

為防止類似情況再次發生,制定整改措施如下:

1.停止從該供應商處購進原料,加強對其他供應商的審計考察;

2.加強原料入廠檢驗;

3.再次生產該產品時,委託第三方的型式檢驗由每年1次改成每批1次。檢及型式檢驗均符合要求,才予以放行發貨。

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