390 North Orange Avenue, Suite 2300 | Orlando, FL 32801 | United States
FDA DETENTION
FDA DETENTION

The FDA may detain without physical examination certain products from specific manufacturers.

Some companies became clients when their DHL, UPS or FedEx international shipments were detained because they did not file Prior Notices (PN). Fortunately, ITB HOLDINGS LLC offers same day PN filing upon request for only $40.00.

Also, we can help create a food or OTC drug label as soon as possible, when needed.

When products in your shipment violate or appear to violate FDA laws and regulations, FDA may detain your product and issue a Notice of FDA Action with the designation of “Detained.”
WHY YOUR CARGO COULD BE DETAINED

Your products may be detained because they appears to be:

  • adulterated
    the product is contaminated, is not safe, or does not otherwise meet applicable standards
  • misbranded
    the labels contain false or misleading information
  • 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.

The refusal to permit inspection of a foreign facility or reasonable access to FDA’s inspectors, combined with other evidence, provides an appearance that the firm’s products are manufactured, processed, or packed under insanitary conditions. Therefore, the products manufactured or exported by that facility, will be subject to refusal of admission into the United States.

FDA detains your shipment, then what?

Notice of Detention and Hearing is issued by the FDA.

Your options include submitting:

■ evidence (testimony) to overcome the appearance of a violation.

■ a request to recondition the products to correct the violation.

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

FDA DETENTION
COMPLIANCE SERVICE
$350.00 | SERVICE FEE