Global Import Agent

FDA Detention Assistance

Support for importers whose shipments are detained, refused or placed on FDA Import Alert.

· By the Global Import Agent team
Overview

Service overview

We identify why your shipment was detained, prepare the evidence and corrective actions the FDA needs, and manage communication with the FDA and CBP.

Cargo containers moving through an international port

Why this service matters

  • A detained, refused or Import Alert shipment needs prompt action to limit product loss and fines.
  • Common causes: documentation errors, labelling violations, unapproved ingredients, missing FSVP agents.
  • Without corrective action, detained goods may be refused entry, re-exported or destroyed.

FDA Detention Cause Investigation

Resolving a detention starts with understanding the cause, so we review your FDA Detention Notice and identify the actions needed for release.

  • 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
Product documentation being reviewed for compliance
Food & Beverage

FDA Detention Assistance

Communication with FDA & Customs Officials

Our team acts as your liaison with the FDA and US Customs and Border Protection (CBP) throughout the detention.

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

Documentation Preparation & Submission

Incorrect or missing documentation is a common cause of FDA detentions, so we review, correct and submit the compliance documents required.

  • 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 a shipment is detained for contamination, mislabelling or unapproved ingredients, laboratory testing may be needed to show compliance.

  • 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, further steps are needed to remove your supplier from the alert list and prevent future detentions.

  • 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

If a product cannot be released as it is, we arrange options to recondition, re-export or properly dispose of the detained goods in line with FDA 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

Ongoing compliance support

  • Time-Saving

    We handle FDA correspondence and documentation, so you can focus on the rest of your supply chain.

  • Regulatory Assurance

    Corrective actions address the root cause of the detention, not just the current shipment.

  • Peace of Mind

    A clear plan for release reduces the risk of re-exportation, destruction or financial loss.

What you'll need

Move quickly: share the detention paperwork and your supporting evidence.

  • The FDA Detention NoticeSo we can identify the compliance issue raised.
  • Supplier compliance historyPast records that show your supplier's track record.
  • Prior Notice and FSVP documentsThe filings and records linked to the shipment.
  • Certificates of AnalysisLaboratory reports that support the product's release.

Official sources

Related services: FDA enforcement in 2026: US food import compliance

Client feedback

Trusted support, in our clients’ own words.

“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 MckayAstute Beverages
Frequently asked questions

FDA Detention Assistance

Requirements vary by product and destination. These answers outline the starting point for the questions we receive most often.

Ask our team

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.

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.

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.

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.

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.

Can you help with FDA labeling compliance?

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.

Discuss your requirements

Talk through your product and target market with our team.

Consultation

Tell us what you need to import.

Share your product, target market and compliance question. A member of our team will respond promptly.

Scope your product and target market
Identify the applicable regulatory route
Receive a clear proposal and next steps