Consumer Products Import Detention

SITUATION

A company’s imported FDA-regulated products without first confirming that their labels complied with FDA regulations.

PROBLEM

The shipment was detained by the FDA because the labels failed to meet FDA label regulations, causing the products to be deemed misbranded and adulterated under federal law, and the company was issued a FDA Notice of Action.

SOLUTION

We worked with the FDA on behalf of the company to relabel the products in a way that is compliant with FDA label regulations and secured release of the detained entry.

BENEFITS

The company was able to stay off of a FDA import alert and the shipment was able to be sold in the United States, rather than being subject to refusal. By addressing the root causes of the detention, we were able to avoid the issuance of a refusal and saved the shipment from being re-exported or destroyed.

For more information, contact Katherine Giannamore at 305-780-1544 or [email protected].