FDA can hold and inspect any imported food, drug, cosmetic, device, or supplement. If FDA finds any apparent violations during its inspection, FDA can detain and possibly refuse the goods and force the importer to export or destroy the goods. However, FDA is not always right. We can help you manage the process and often get products released. Once you’ve heard from the FDA, don’t waste valuable time. Get expert help fast!

We can help you quickly and effectively navigate FDA inspections, ensuring that any apparent violations are addressed and your products are released in a timely manner. We have the expertise to help you manage the process and get your products released. Don’t waste valuable time once you’ve heard from the FDA – let us provide the expert help you need to protect your business and get back on track.

Import Detention – A detention is when FDA finds what appears to be a violation with imported goods and issues an FDA Notice to the importer. In the Notice FDA gives the importer notice of the alleged violations and the duration of the hearing period (i.e., the “Respond By Date”). During the hearing period, the importer can present evidence to overcome the apparent violation or they can request to recondition the goods to remove the violations. If the importer convinces FDA that there is no violation or they have reconditioned the goods to take away the violation, then FDA will release the goods. If the importer cannot do either of these, then FDA will refuse the goods.

Customs Bond – when filing an entry with US Customs and Border Protection, the importer’s Customs Broker will also purchase a bond for the importer allowing the goods to go to destination, subject to the terms of the bond and pending FDA inspection. The importer can store the goods at a nearby private warehouse or their own facilities during the bond period. If FDA releases the goods, then the bond is released. If FDA refuses the goods, then the importer must arrange to export or destroy the goods. If FDA refuses the goods, but the importer distributes and thus cannot export the goods, then the importer will be subject to US Customs and Border Protection “liquidated damages” in the amount of three times the commercial value of the goods.

Import Hold – Sometimes goods will be on “hold” pending FDA’s determination. This does not mean that the goods are detained or violative, it only means that FDA has not yet determined whether the goods are admissible yet. This should not be confused with a “detention” – where FDA has issued charges.

Hearing – A hearing is typically a series of emails or phone calls where we submit our testimony to demonstrate that your product is in compliance with the FDA.

Charges – These are the violations or reasons your product has been detained.

Respond by Date – This is how much time we have to respond so we’ll need to act quickly!