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FDA
Detention
AVOID FDA DETENTION

Detention occurs when products are refused entry, either by the U.S. Food & Drug Administration (FDA) or the U.S. Customs and Border Patrol (CBP), acting on the FDA’s behalf.

ITB HOLDINGS LLC assists domestic and foreign companies that are manufacturers, exporters, importers, warehouses or distributors, when the FDA has reason to believe that their products do not conform to U.S. laws and regulations.

FDA DETENTION EXPLAINED

■ FDA may consider the failure to provide adequate Prior Notice as a factor in determining whether and where to examine an article of food.

■ Some detentions are the result of the FDA’s Import Alert List of imported products manufactured by or exported by companies with detected patterns of noncompliance.

■ FDA places the responsibility back on the buyer or ultimate consignee, to ensure that the products being imported into the United States are in compliance.

DETENTION WITHOUT PHYSICAL EXAMINATION (DWPE)

Products subject to DWPE will be detained by the FDA until it can be shown that they are safe and meet pre-approved standards.

Companies exporting or importing products are strongly encouraged to familiarize themselves with the FDA Import Alert List.

FDA’s Import Alerts

Click here, for most recently published, by date.

Reviewing this list allows you to make an informed decision, and to determine what types of product testing or evaluations to require from the seller prior to shipment. This can prevent the headache associated with a detained shipment, saving you time and money.

If you receive an FDA notice, read it immediately and carefully!

Then, contact ITB HOLDINGS LLC by email.

Chat is available 24 hours a day, seven days a week, for faster response to your questions.

 

Why was your product detained?

A product may be detained because it appears to be:

  • adulterated, meaning the product is contaminated, is not safe, or does not otherwise meet applicable standards
  • misbranded, meaning the labels contain false or misleading information
  • an unapproved new drug
  • manufactured, processed, or packed under insanitary conditions
  • forbidden or restricted for sale in the country in which it was produced or from which it was exported

If you are unable to overcome the appearance of a violation, your product will be refused admission and you can work with U.S. Customs and Border Protection (CBP) and FDA to destroy the product or export it from the U.S within 90 days of the refusal.

CONTACT ITB HOLDINGS LLC