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US Importer of Record (IOR) Services

US Importer of Record (IOR) Services for Food, Beverage & Medical Device Imports

Importing food, beverages, and medical devices into the U.S. requires a designated Importer of Record (IOR) to handle customs clearance, regulatory compliance, and FDA requirements

  • Ensures compliance with FDA, USDA, and CBP import regulations
  • Manages customs duties, import taxes, and required documentation
  • Prevents shipment delays and FDA import refusals
  • Acts as the legal point of contact with U.S. regulatory authorities

 

Our IOR Services provide end-to-end import compliance for food and beverage companies, as well as medical device manufacturers, ensuring hassle-free entry into the U.S. market

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Why Importer of Record (IOR) Services are Essential

The Importer of Record is legally responsible for ensuring that imported food, beverages, and medical devices comply with U.S. regulatory requirements. Without an IOR, shipments can face:

  • Delays in customs clearance and import holds
  • FDA and USDA detentions for non-compliance
  • Fines, penalties, and potential shipment rejections
  • Regulatory scrutiny and loss of import privileges

For foreign food and beverage manufacturers, an IOR ensures that all imports meet safety, labeling, and documentation requirements, reducing the risk of costly disruptions

Our Core Importer of Record (IOR) Services

What's Included In Our Importer of Record Services

Acting as Your Official Importer of Record

We serve as your designated Importer of Record, ensuring your food, beverage, and medical device imports comply with FDA, USDA, and CBP regulations

  • Legally acting as the IOR for food, beverages, and medical devices
  • Ensuring accuracy in facility details to avoid delays or errors
  • Providing a U.S.-based IOR for foreign businesses without a U.S. entity

FDA & USDA Compliance for Imported Products

All imported food and beverage products must meet strict FDA and USDA safety standards, including FSVP and labeling compliance

  • FSVP compliance verification for foreign food suppliers
  • FDA Prior Notice filing for imported food shipments
  • Food safety documentation review and risk assessments

U.S. Customs Clearance & Import Documentation Management

We handle all required customs paperwork, tariff classifications, and import duties to ensure fast and efficient entry into the U.S.

  • Customs entry filing and HS code classification
  • Calculation and payment of import duties and taxes
  • Support for FDA and USDA inspections at ports of entry

Labeling & Ingredient Compliance for Imported Products

Proper labeling is critical for FDA and USDA compliance, preventing misbranding violations and import refusals.

  • Ingredient and allergen declaration verification
  • Medical device labeling compliance under 21 CFR Part 801
  • Country of origin labeling and nutritional facts validation

Record-Keeping & Post-Import Compliance Management

IORs must maintain detailed records of import transactions for regulatory audits and inspections. We offer support for FDA recalls and regulatory investigations

  • Post-market compliance monitoring for food and beverage safety
  • Digital storage of import declarations and safety records
  • Audit-ready documentation for FDA, USDA, and CBP reviews

Resolution of FDA & USDA Import Detentions

If your food, beverage, or medical device imports are detained or rejected, we provide corrective actions and regulatory solutions

  • Assistance with FDA and USDA import refusals
  • Root cause analysis and corrective action planning
  • Re-submission of documentation to resolve compliance issues

Why Choose Our Importer of Record (IOR) Services?

Industry-Specific Expertise

Specialists in FDA and USDA regulations for imported products

End-to-End Customs Support

Handling all import documentation, duties, and customs clearance

Comprehensive Compliance Solutions

Covering FSVP, labeling, and post-market compliance

Dedicated Support for Foreign Businesses

Providing a legal U.S. presence for companies without a domestic entity

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 is an Importer of Record (IOR) for food and beverage imports?

An Importer of Record (IOR) is the legally responsible party for ensuring that imported food and beverages comply with FDA, USDA, and CBP regulations and managing all customs clearance requirements

Q. Who needs an Importer of Record for food and medical device imports?

Any foreign manufacturer, distributor, or exporter that does not have a U.S. entity needs an IOR to legally import food, beverages, and medical devices into the U.S.

Q. What does an Importer of Record do for food and beverage imports?

  • Ensures regulatory compliance with FDA and USDA
  • Manages customs clearance, duties, and tax payments
  • Submits required import documentation and Prior Notices
  • Maintains post-import records for regulatory audits

Q. Can a foreign company act as its own Importer of Record?

No, a foreign company without a U.S. entity cannot act as its own IOR. A third-party Importer of Record must be appointed to handle regulatory compliance and customs clearance

Q. What happens if food or beverage imports do not comply with U.S. regulations?

  • FDA or USDA may refuse entry of non-compliant shipments
  • Importers may face fines and legal penalties
  • Products could be recalled or destroyed at the importer’s expense
  • Additional inspections and compliance checks may be required

Q. How do I appoint an Importer of Record for my business?

You can appoint an IOR by working with a qualified regulatory compliance provider that specializes in food, beverage, and medical device imports, ensuring full FDA and USDA compliance

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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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