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What to know FDA Import Alerts & Import Refusals?

January 27 2023

Import Alerts notifies that a product is subject to detention without physical examination (DWPE) because it violates or does not comply with FDA regulations and laws. Before importing into the United States, importers must monitor whether their products are for DWPE.

What is the purpose of an import alert?

  • Prevent potentially violative products from being distributed in the United States;

  • Free-up agency resources to examine other shipments;

  • Provide uniform coverage across the country;

  • Place the responsibility back on the importer to ensure that the products being imported into the United States are in compliance with the FDA's laws and regulations.

What can you do if your product is detained without physical examination (DWPE)?

If your product is detained without physical examination, you have the right to provide evidence to the FDA in an attempt to overcome the appearance of the violation. If you do not provide evidence to the FDA, or if the information you provide is not sufficient to overcome the appearance of the violation, your product is subject to refusal into the United States.

What are some common reasons a petition for removal from DWPE is denied?

  • Failure to submit steps the firm has taken to correct the violations

  • Failure to present information that would give the FDA confidence that future shipments would be in compliance

  • Failure to submit entry documentation for five (5) consecutive, compliant shipments

  • Failure to submit other information as required by the import alert

  • Reoccurrence of the violation

  • Staging shipments:

o Breaking up large shipments into smaller ones to count as more than one

o Shipping small quantities of product as opposed to historical size

Import Refusals are cases in which the FDA refuses certain products' importation into the United States due to the failure to comply with FDA regulations upon inspection of the shipment at the custom. Import Refusals become irrevocable, so you must carefully monitor those products and suppliers.

How will I be notified of a refusal?

FDA will always issue a Notice of Refusal of Admission to the importer of record (who is the same person or firm who was issued the Notice of Detention). Local FDA practices may also include sending copies to the broker (entry filer) and consignee. FDA will also notify CBP of the refusal.

Can I appeal the refusal decision?

A refusal is a final decision. Unless the refusal was issued by FDA in error, consideration is not given to a request to rescind the refusal.

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