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

 

　　美國FDA還要求企業(yè)提供周期性狀態(tài)報告，以便及時掌握召回進展情況。

 

　　部分原文報道如下：

 

　　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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