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思創公司順利通過FDA第二次現場審核

作者:武漢思創來源:www.lywsdd.com 瀏覽次數: 日期:2017年11月23日 16:22
繼2014年7月思創順利通過美國FDA首次現場審核后,2017年8月21日至24日,美國FDA特派檢查官James Michael Simpson  Jr對思創公司進行第二次現場審核。檢查官依據《美國聯邦法規法典》對公司的研發、生產、檢驗、供應鏈、市場及售后服務等各個環節進行了細致、嚴格的審核,經過為期4天的審核,武漢思創電子有限公司再次順利通過美國FDA現場審核。
美國FDA審核是美國食品藥品監督管理局代表美國聯邦政府,不定期派遣審核官員依據《美國聯邦法規法典》第21冊第820部分法規要求,對供應美國市場的所有醫療企業的質量管理體系進行全面審查。嚴格要求各醫療企業切實遵守法規要求,確保制造出的產品的有效性和安全性。美國FDA審核以審查嚴苛聞名于世界。
 

圖為公司總經理王平正在向FDA檢察官介紹公司情況

所屬類別: 思創新聞

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