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FDA Detention Assistance

Resolve FDA Import Holds Quickly & Avoid Costly Delays

If your shipment has been detained, refused, or placed on FDA Import Alert, immediate action is required to prevent product loss, fines, or re-exportation. Our FDA Detention Assistance service helps importers quickly identify and resolve compliance issues to get products released from U.S. Customs and Border Protection (CBP) and the FDA.

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Why Do Shipments Get Detained by the FDA?

When importing food, beverages, dietary supplements, medical devices, cosmetics, or pharmaceuticals, the FDA carefully inspects products for compliance. If your shipment does not meet U.S. requirements, it may be detained or refused entry.

Common reasons for FDA detentions include:

  • Incomplete or incorrect documentation – Missing prior notice, FDA registration errors, or misclassified products
  • Labeling violations – Non-compliant ingredient lists, missing allergen declarations, or misleading health claims
  • Unapproved ingredients – Use of additives, colorants, or restricted substances not permitted in the U.S.
  • Microbial contamination or adulteration – Evidence of bacteria, foreign matter, or unsafe food additives
  • Failure to comply with FSVP requirements – No U.S.-based Foreign Supplier Verification Program (FSVP) agent
  • Products subject to FDA Import Alerts – Suppliers flagged for repeated violations or public safety concerns

Without the right corrective action, detained shipments may be refused entry, re-exported, or even destroyed, causing significant financial loss. Our FDA Detention Assistance service helps resolve issues efficiently, ensuring a faster release of your goods.

FDA Detention Resolution

Our FDA Detention Assistance Services

We can get your product released from FDA detention through our comprehensive services below

FDA Detention Cause Investigation

The first step to resolving a detention is understanding the cause. We conduct a detailed review of your FDA Detention Notice and identify the necessary actions to get your shipment released.

  • Reviewing FDA Detention Notices and identifying compliance issues
  • Contacting FDA officials for clarification of the detention
  • Assessing your supplier compliance history to determine potential risks

Communication with FDA & Customs Officials

FDA detentions require direct communication. Our team acts as your liaison with the FDA and U.S. Customs and Border Protection (CBP), ensuring your case is handled professionally.

  • Acting as your representative to FDA and CBP officials
  • Preparing formal responses to FDA detention inquiries
  • Managing communications and negotiations to expedite product release

Documentation Preparation & Submission

Incorrect or missing documentation is a leading cause of FDA detentions. We review, correct, and submit all necessary compliance documents to avoid further delays.

  • FDA Prior Notice correction for food and beverage imports
  • Assistance with FSVP compliance documentation
  • Submission of Certificates of Analysis & laboratory reports for verification

Laboratory Testing & Product Compliance Support

If your shipment is detained due to contamination, mislabeling, or unapproved ingredients, laboratory testing may be required to prove compliance. We coordinate with FDA-approved labs to expedite the process.

  • Microbial, allergen, and chemical analysis for detained product
  • Ingredient verification testing for dietary supplements and cosmetics
  • FDA-compliant laboratory submission to support product release

FDA Import Alert & Warning Letter Resolution

If your shipment is flagged under an FDA Import Alert, additional steps must be taken to remove your supplier from the alert list and prevent future detentions. We can reomve import alerts and potentially resolve import bans

  • Assistance with removal from FDA Import Alerts
  • Development of Corrective Action Plans (CAPs) to address compliance violations
  • Ongoing monitoring and supplier verification to prevent future issues

Reconditioning, Re-Exportation, or Product Destruction

In the worst case scenario, if your product cannot be released as is, we provide solutions and providers to either recondition, re-export, or properly dispose of detained goods per FDA compliance guidelines

  • Guidance on FDA reconditioning requests to modify the product
  • Assistance with re-exportation or alternative market entry
  • Coordination of safe and compliant product disposal if required

Benefits of Our FDA Detention Resolution Services

Expert Regulatory Support

Our team specializes in FDA import regulations and has a proven track record of resolving detentions.

Fast & Efficient Resolution

We work quickly to reduce delays and prevent unnecessary storage fees or financial losses.

Full-Service Compliance Assistance

From investigation to resolution, we handle every step of the process.

Preventative Compliance Strategies

We help identify and correct compliance issues before future shipments arrive in the U.S.

Global Import Agent have successfully worked with me to land product in the U.S and remain compliant for FDA regulations. I'm really happy with their response times, and easy to use tech platform that facilitates the process.
Jane Mckay
Jane MckayAstute Beverages
I had hit a brick wall trying to get my FDA number for export of my rum to the USA. Ryan and James knew all the right contacts to sort this out for me. I could not have done it without Global Import Agent. They even sorted out my prior notification paperwork for me. I can highly recommend them.
James Singlehurst
James SinglehurstRevival Rum
Ryan, Chris and their team were exceptional in getting our food supplement product FSVP compliant. Pretty good experience with Global Import Agent overall.
Kelvin Yeo
Kelvin YeoAdvagen
Great level of service in the 3 months we have been working with Global Import Agent to date. From the first call with Fabrizzio to the comms with Ryan, James & Carlos, all has been good and the progress we are making is fantastic!
Jeff Webster
Jeff WebsterHunter & Gather
I recently had the pleasure of working with Ryan and his team for a label review of a dietary supplement, which was intended for commercialization in the United States. My experience was overwhelmingly positive, as they provided exceptional and professional support throughout the process.
Renato Di Lorenzi
Renato Di LorenziLoli Pharma
We use Global Import Agent as our FSVP agent for importing dietary supplements into the US from the EU. They've provided us with professional high-quality service thus far. Recommend!
Keiu Kadarik
Keiu KadarikEcosh Life
We were a start up working on our first import, and Global Import Agent was superb in taking care of our documentation and import process. Highly recommend.
Hee Joong Kim
Hee Joong KimMuom Life
Ryan is very helpful from the beginning to end. He responds super fast and he is on point to the issue / objectives.
Wonsik Woo
Wonsik WooLifeLab
James, Ryan and Carlos have been really helpful all along our FSVP. Great service.
Anahi Cabrera Herrera
Anahi Cabrera HerreraScience In Sport
Flexible and helpful FSVP agent. After comparing a couple of agents, this one is the one we picked. No regrets!
Andreas Edström
Andreas EdströmSwedish Signature AB
they are fast, efficient, and always open to help. They have been a great support for me and my company
Alba Rodríguez
Alba RodríguezGricha
Great to deal with, cost efficient and professional, highly recommended
Stephen Goument
Stephen GoumentGolden Turmeric
​What our clients say

Client Feedback

Read what our clients have to say about our services and how we have helped them export product.

Q. What should I do if my shipment is detained by the FDA?

  • Do not attempt to move or distribute the goods.
  • Review the FDA Detention Notice to determine the issue.
  • Contact us immediately for expert assistance in resolving the detention.

Q. How long does it take to resolve an FDA detention?

  • Minor documentation issues can be resolved within a few days.
  • More complex detentions (e.g., laboratory testing or reconditioning) may take several weeks.
  • Our team works quickly to shorten the detention period and avoid extra costs.

Q. Can I appeal an FDA detention or refusal?

  • Yes, you can challenge a detention by submitting evidence, explanations, and corrective actions.
  • We assist in preparing legal responses and negotiating with FDA officials to overturn unjustified detentions.

Q. What happens if my product is refused entry into the U.S.?

  • If your product cannot be released, you may:
    • Recondition the product to meet FDA standards.
    • Re-export it to another market.
    • Dispose of the product under FDA supervision.
  • We help determine the best cost-effective solution for your business.

Q. How can I prevent future FDA detentions?

  • Work with a FSVP Agent to ensure supplier compliance.
  • Pre-screen products and documentation before shipping.
  • Conduct pre-import compliance reviews for labeling, ingredients, and safety standards.
  • Ensure your foreign suppliers are FDA-registered and meet U.S. regulatory requirements.

Q. Can you help with FDA labeling compliance?

What should I do if my shipment is detained by the FDA?Yes, we offer comprehensive labeling compliance services, including reviewing your product labels to ensure they meet FDA requirements for nutrition facts, allergen statements, claims (e.g., "organic"), and more.

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Our team is friendly, responsive and we love to talk to people interested in what we do. Feel free to get in touch and one of our team will always get back to you. Guaranteed!

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FDA detentions can disrupt your supply chain, increase costs, and damage your business reputation. With our specialized expertise and fast resolution strategies, we help you release your shipments quickly and prevent future compliance issues. .

Our friendly team is always happy to help and will reach out as soon as possible.


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