What You Need To Know

FDA Detentions occur because the FDA is exercising its jurisdiction to review documentation for a product that is trying to enter the United States. The process can take time and cause missed deadlines, so finding an advocate to help you identify the appropriate actions and responses can get your violations resolved quickly and efficiently. 

FDA Detentions & Notice Of Action

If you have a product detained by the FDA, you will receive a Notice of Detention.  You will be given a date for providing a testimony to overcome the violation. Typically, you’ll have 10-20 days to deliver a response, otherwise, you can be issued a refusal of admission.

Often when people receive an FDA Detention, they assume the FDA is correct. We never take the FDA’s decision for granted and utilize our years of experience to help you get your goods released.

Terms to Familiarize Yourself With
Learning these terms will help you understand the process for resolving your FDA Detention.

Testimony – This is any information that we can provide to overcome the violation. We’ll work with you to understand, gather, and submit all evidence.

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!

How an FDA Lawyer Can Help

We’ll first evaluate why the FDA has detained your shipment, and determine whether or not we agree with their findings. The most common reasons for product detainment by the FDA include:

  • The product has been determined to be unsafe or contaminated.
  • Labels on the product appear to be false or misleading.
  • The product is not approved for sale in the United States.
  • Packaging or processing looks to have been conducted under unsanitary conditions.
Notice of Detention
The laws and regulations that appear to have been violated will be outlined in your Notice of Detention.

While this process can be frustrating and confusing, the best thing you can do is to consult with a Customs law attorney to help you create a plan to:

  • Gather all documentation and facts about why your shipment has been detained.
  • Review the Notice of Detention with a Customs law attorney so we can help you understand the violation and answer any questions that you may have.
  • Pay very close attention to the Respond By date. If you miss this date, the FDA will refuse admission and you’ll have 90 days to move or destroy your shipment.
  • Provide a detailed explanation showing why your product has not violated FDA requirements or how you have resolved all issues.

It’s important not to respond until you fully understand the charges and have gathered all of your evidence. It is our job to help you objectively view the situation and navigate the FDA’s requirements. Not responding properly can lead to making matters worse, further delaying your shipment and costing more money in the long run.

Solve Your FDA Problems
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Take the first step to freedom and schedule a call with us today.

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