按照美國(guó)FDA的要求，產(chǎn)品召回企業(yè)需要及時(shí)將召回事項(xiàng)通知相關(guān)的FDA轄區(qū)辦公室。企業(yè)需提供召回原因、風(fēng)險(xiǎn)評(píng)估、生產(chǎn)數(shù)量、銷售信息、產(chǎn)品召回策略、聯(lián)系方式等詳細(xì)信息，還需要將召回事項(xiàng)通知直接客戶，并提供給客戶一套報(bào)告方案。

 

　　美國(guó)FDA還要求企業(yè)提供周期性狀態(tài)報(bào)告，以便及時(shí)掌握召回進(jìn)展情況。

 

　　部分原文報(bào)道如下：

 

　　The Food and Drug Administration （FDA or Agency） is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 （PRA）， Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on FDA recalls for human drugs, biological products, devices, animal drugs, food, cosmetics, and tobacco.

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