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Removing Your Client’s Import Alert

Posted by Lisa Capote | Jul 06, 2011 | 0 Comments

As you may already know Import Alerts, or FDA's automatic detention lists, can cause serious issues for your clients.  Import Alerts are also known as detention without physical examination.  An importer that finds itself or its products listed on FDA's Import Alert lists faces the difficult task of proving to FDA's officers that its products are in compliance.  Proof can come in a variety of methods, but the common approach is through a private laboratory test. These tests can become quite costly when the importer must conduct them every importation.

What is the best course of action for these importers? How can your client get off this list in hopes of smoother, quicker importation of their products? There are a number of steps that need to be taken by these importers.  This is a guideline to help them move in the right directions so that the product and/or company can be removed from the list.

The first step is to determine what was wrong with the product that resulted in the original Import Alert being issued.  The type of issue will dictate the best manner and means of resolving the issue.  The issue must be resolved, whether it is a labeling concern or an ingredient issue. The necessary steps to resolve the issue and ensure that it does not happen again must be documented, preferably in newly enacted company protocols that must be followed by employees.

Once the issue has been addressed and new procedures have been implemented and documented to ensure that the issue does not occur again then the importer must make entry.  The product will be detained automatically by FDA and a hold designation will be issued. At this point it is up to you, as their customs broker, or an attorney retained by your client, to communicate with FDA and request that the product be allowed to be sent out for private laboratory testing.  The testing facility must be approved by FDA and the manner and means of collecting samples must be in accordance with FDA standards.  It is imperative that the correct laboratory be chosen. If the sampling method is done incorrectly, or the method of testing is not industry standard, then the product will not be released and another sample will have to be sent for testing.

After the first successful testing and release the importer must bring the product in four more times, for a total of five shipments.  Each shipment must be tested and released.  Finally, after five successful releases a petition may be submitted to FDA's Division of Import Operations & Policy for consideration of removal.  Once the petition is granted your client will be removed from Import Alert and detentions without physical examination will be a thing of the past.

About the Author

Lisa Capote

Ms. Capote is the founder and Managing Partner of Capote Law Firm. She founded the minority, woman owned law firm in 2006 with the goal to provide quality service to FDA regulated companies. Since that time her practice has grown to include other US federal agencies as well as an international trade component.

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