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Import Alert Removal Assistance

Get Your Products Off FDA Import Alert & Resume Uninterrupted Trade

Being placed on an FDA Import Alert can halt your shipments, disrupt your business, and lead to long-term supply chain issues. If your products or suppliers are flagged for detention without physical examination (DWPE), immediate action is required to restore compliance and remove your business from the Import Alert list. Our expert team guides you through the FDA Import Alert removal process, helping you implement corrective actions and regain approval for U.S. imports.

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What is an FDA Import Alert?

The FDA places products, manufacturers, and suppliers on Import Alert when they pose a potential risk to public health or fail to meet regulatory requirements. Products flagged under an Import Alert are subject to automatic detention at U.S. ports, often without physical inspection, meaning they cannot enter the country unless the importer provides sufficient evidence of compliance.

Common reasons for being placed on an FDA Import Alert include:

  • Repeated non-compliance with FDA regulations – Safety violations, mislabeling, and lack of documentation
  • Microbial contamination or adulteration – Including Salmonella, Listeria, E. coli, or heavy metal contamination
  • Unapproved ingredients or food additives – Including restricted chemicals, pharmaceuticals and preservatives
  • Failure to comply with Foreign Supplier Verification Program (FSVP) requirements
  • Misleading or unauthorized labeling and marketing claims
  • Refusal to cooperate with FDA inspections or provide required documentation

If your shipments are being automatically detained, you may already be subject to an Import Alert. Our FDA Import Alert Removal Assistance helps businesses regain compliance and get their products back into the U.S. market.

Import Alert Removals

Our FDA Import Alert Removal Services

Import Alert Investigation & Risk Assessment

We conduct a detailed review of the Import Alert listing, identify the root cause, and develop a corrective and preventive action strategy.

  • Verification of Import Alert status and reason for placement
  • Review of past FDA detentions, warning letters, and inspection findings
  • Customized strategy to address FDA concerns and initiate removal

Corrective Action Plan (CAP) Development

A well-structured Corrective Action Plan (CAP) is required to demonstrate compliance and convince the FDA to lift the Import Alert.

  • Identification of compliance violations and action steps for resolution
  • Development of a formal Corrective Action Plan (CAP) for FDA submission
  • Supplier compliance verification and risk management strategies

Third-Party Laboratory Testing & Compliance Audits

The FDA  requires proof that your products meet safety standards. We arrange third-party lab testing and compliance audits to support Import Alert removals.

  • FDA-compliant microbiological, chemical, and toxicology testing
  • Supplier facility audits to assess GMP compliance
  • Submission of test results and compliance reports to FDA

Petition & Evidence Submission to the FDA

Once corrective actions have been implemented, we prepare and submit a formal petition to request removal from the Import Alert list.

  • Preparation of an official FDA Import Alert removal request
  • Submission of compliance documentation, lab test results, and audit reports
  • Tracking and monitoring the status of removal proceedings

Ongoing Monitoring & Compliance Maintenance

Even after removal, maintaining compliance is critical to preventing future Import Alerts. We provide ongoing monitoring and support to ensure regulatory compliance.

  • Regular FDA compliance audits and risk assessments
  • Supplier monitoring to ensure continued adherence to U.S. regulations
  • Quick-response support for potential regulatory issues

Facility Registration Verification & DUNS Correction

We handle the entire facility registration process for food, beverage, dietary supplements and cosmetics, ensuring your business complies with FDA registration regulations.

  • Preparing and submitting your FDA facility registration
  • Ensuring accuracy in facility details to avoid delays or errors
  • Managing renewals during the biennial renewal period

Why Choose Us for FDA Import Alert Removal?

Proven Success

We have helped numerous companies remove Import Alerts and restore trade operations.

Expert Compliance Knowledge

Our team specializes in FDA import regulations, supplier verification, and compliance audits.

Fast & Effective Strategies

We focus on quick and efficient resolution, minimizing financial and operational disruptions.

Full-Service Support

From CAP development to final petition submission, we handle the entire Import Alert removal process.

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. How do I know if my product or supplier is on an FDA Import Alert?

You can check the FDA’s Import Alert Database, or we can conduct a compliance assessment to determine if your shipments are subject to automatic detention.

Q. Can a company be removed from the FDA Import Alert list?

Yes, but removal requires demonstrating full compliance with FDA regulations. This includes:

  • Corrective actions
  • Laboratory testing
  • Compliance audits
  • Proper petition submission

We help manage the entire Import Alert removal process.

Q. How long does it take to remove an Import Alert?

  • The timeline depends on the complexity of the case and corrective actions required.
  • Some removals can be completed in 3–6 months, while others may take longer if extensive testing and facility audits are needed.
  • We work to expedite the process and communicate with the FDA on your behalf.

Q. What happens if I continue to import while on Import Alert?

  • Your shipments will be automatically detained at the port.
  • You will face higher compliance scrutiny and potential penalties.
  • Your products may be refused entry or subject to destruction.

We strongly recommend taking action to remove the Import Alert as soon as possible.

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

If your shipment is detained you should contact us immediately, we can assist you with:

  • Determining the cause of detention
  • Communicating with the FDA or CBP
  • Preparing and submitting the required documents for release
  • Implementing corrective actions to prevent future detentions

Q.How can I prevent future FDA Import Alerts?

  • Ensure supplier and product compliance before shipping.
  • Work with an FSVP Agent to meet Foreign Supplier Verification Program (FSVP) requirements.
  • Conduct regular audits, lab testing, and compliance checks.
  • Maintain accurate labeling, documentation, and food safety protocols.

Want To Ask Something?

We are always ready to answer your questions

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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Get Expert FDA Import Alert Removal Assistance Now

If your business is facing automatic detentions, import refusals, or regulatory scrutiny, immediate action is required. Our Import Alert Removal specialists provide the expertise, strategy, and compliance solutions needed to get your products off the Import Alert list and back into the U.S. market.

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


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