Steps to take when you’re detained

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Step 1:

Gather the facts.

Do not argue with FDA or the inspector who detained your product. Do not respond to the detention charges until you have all the information and are aware of FDA’s concerns. FDA issues a Notice of Action (NOA) to the importer of record for every action taken related to a shipment. Gather every Notice of Action so that you have a complete understanding of the state of your shipment.

Failing to understand the charges and the nuances of the regulations you might have violated can inadvertently make matters worse.

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Step 2:

Contact us immediately.

Do not try to handle your detention alone. Even if Registrar Corp is not designated as the U.S. Agent for your facility, we can assist with your detention. Having a professional consultant knowledgeable in FDA procedures on your side can save you time, money, and hassle.

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Step 3:

Respond to the Notice of Action.

When a shipment is detained, FDA issues an NOA with the exact charges being levied against the products. The NOA will include a “respond by” date, a deadline for you to communicate your intentions to FDA (e.g. extension request, 766 request to recondition, etc.). This deadline must be taken seriously, because if it passes without a response, FDA can refuse even admissible goods.

If you have sufficient proof that the goods are in compliance, a testimony of admissibility may be submitted to request that FDA release them.

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Submitting a Reconditioning Request or Testimony of Admissibility

In cases where reconditioning is necessary to resolve the charges, Registrar Corp can guide you through the 766 reconditioning request process to request permission from FDA. We can also help you navigate the procedures for additional submission documentation such as color batch certificates or laboratory analysis results. If the detained products are in compliance, our team will assist you with a testimony of admissibility to get your shipment released.

We’re committed to resolving your detention swiftly and effectively so your shipments can move quickly to their final destination.

Registrar Corp assists with detentions quickly and efficiently.

Time is of the essence when your products are detained. Get the answers you need to reduce as much risk to your supply chain as possible.

Frequently Asked Questions

A detention occurs when FDA inspects a shipment upon entry to a U.S. port and determines that the products are not in compliance with U.S. law. FDA will then detain the products, charge them with specific violations, and not allow them to enter the U.S. market. If not addressed, FDA will refuse entry of the shipment, which may require the goods to be re-exported or destroyed.

An import refusal can result in the manufacturer being placed on an import alert for that product, which will cause future shipments of that product to be detained without any physical examination by FDA.

There are many reasons your product shipment might be detained. Some examples include:

  • Adulteration (illegal colors or pesticides, undeclared allergens, etc.)
  • Misbranding (failure to register, labeling errors, etc.)
  • FDA Import Alerts

A detained shipment must not be moved, sold, or otherwise distributed without permission from FDA. An importer should communicate clearly with their customs broker and FDA about moving any goods while the detention is being resolved.

If an importer is pursuing a course of action that should result in a successful testimony of admissibility or reconditioning request, FDA may grant an extension upon request. The request must be made before the “respond by” date has passed.

FDA will communicate with a third party (e.g., consultant) who has been given written authorization by the importer of record or consignee. Registrar Corp assists as an authorized representative multiple times each year to secure the release of our clients’ detained shipments.

An importer may voluntarily request refusal of a shipment which can expedite the destruction or re-exportation process. However, be aware that this shipment would still be classified as an import refusal, which will impact the manufacturer’s PREDICT score and could still get them placed on an import alert.

FDA will only accept testimony or a Form 766 from an importer, consignee, or authorized representative. It’s critical for manufacturers to communicate clearly with their importers so that they assist more effectively if a shipment is detained. In most cases, if a shipment is refused and the FDA officer decides that the situation warrants inclusion on an import alert, it’s the manufacturer not the importer who will be placed on the import alert.

For minor violations of U.S. law, FDA may “release with comment” under the condition that violations are fixed by the next shipment of goods. Companies need to address them promptly as FDA will likely stop the next shipment to inspect and verify that the violations are no longer present.

A Notice of Action is a written document sent by FDA to the importer of the detained shipment and the customs broker who filed the entry. It presents the formal reasons for detention and identifies which FDA regulations may have been violated.

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