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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.

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.”

Your product may be detained because it 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.

FDA detains your product, 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 product to correct the violation.

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.