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U.S. Department of Health and Human Services

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Reasoning: Action 16

FDA will allow interested members of the public to receive email notifications when an Import Alert is posted on the FDA Web site, or an existing Import Alert is updated.

Reasoning:

Industry requested a means to get up-to-date information about Import Alerts from FDA.  Placement of a product on an Import Alert for DWPE means that FDA has sufficient information to detain that product when it is offered for import into the United States.

Placement on an Import Alert for DWPE has significant implications for manufacturers and distributors of those products.  Based on the information in the Import Alert, FDA may refuse admission of the product unless the importer demonstrates that the product is in compliance with applicable laws before FDA will admit the product into the country or FDA allows the importer to recondition the product.

Companies whose products are on a FDA Import Alert have an incentive to remedy the issue quickly so that they are removed from the list as soon as possible.  The Task Force concluded that real-time notification can assist with this process and that FDA should permit interested members of industry to sign up to receive email notifications when an Import Alert is posted on the FDA Web site, or an existing Import Alert is updated. 

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