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Dealing with FDA Enforcement Issues

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Is your company listed on FDA’s Import Alert Website?

The website is: http://www.fda.gov/ForIndustry/ImportProgram/ImportAlerts/
A sample Import Alert is 66-38, for example, which is for “skin care products labeled as anti-aging creams”. FDA’s Import Alert 66-38 is listed below. You can search by company name, product type and country. If you are listed here, you are officially on FDA’s Import Alert List.

Import Alert

What Does This Notice Mean?

If your company is on an Import Alert you are subject Detention Without Physical Examination (DWPE), these actions can cause timely and costly delays to your importations, and Diaz Trade Law can assist you.

If your company is on an Import Alert, your goods will not be released for distribution by the U.S. FDA until you can prove your goods are in compliance with applicable FDA regulations, and FDA must review and approve your compliance. This will occur for EACH importation until you successfully Petition to be removed from the Import Alert list.

Companies are placed on the Import Alert list when the company’s products are subject to detention without physical examination. This typically occurs when there is a history of violations; the U.S. FDA’s determines that there are health risks imposed by your company’s products; or potentially because of a history of violations in the country or region of manufacturer.

How Can Diaz Trade Law Help?

Diaz Trade Law assists in understanding what is required to have your company removed from the Import Alert List. Diaz Trade Law explains the process, reviews and analyses your documentation and sends the FDA Petitions for the removal of your company from an Import Alert list.

Want more Information?

See our Blog on How To Get Off The FDA ‘Black List’ here:


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Note: If you have documents you would like us to review, please email docs@DiazTradeLaw.com