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FDA U.S. Agent and FSVP Agent Services for Global Importers

If you are based outside the United States and want to sell into the U.S. market, the FDA expects you to have the right representation in place. That usually means appointing an FDA U.S. Agent, an FSVP Agent, or in many cases both. We help you understand which roles apply to your business and provide full support so your communication with the FDA is clear, organized, and compliant. 

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Why These Roles Matter

For many foreign brands, the first contact with the FDA happens through a U.S. Agent or FSVP Agent. If that role is missing, unclear, or handled by someone unfamiliar with FDA rules, you risk shipment delays, missed notices, or avoidable compliance issues. With the right support in place: 

  • The FDA has a reliable contact for inspections and questions. 
  • Your registrations, supplier programs, and records stay organized. 
  • You understand when FSVP applies and when a U.S. Agent is required for other categories such as devices, drugs, and cosmetics. 

Our Solutions

We help you take the right steps to meet FDA requirements. Our services focus on making the process clear, organized, and manageable, giving you practical support as you decide which type of representation fits your situation. 

FDA U.S. Agent Solutions

We act as your official point of contact when registering your food facility, medical device establishment, OTC manufacturer, or cosmetic facility with the FDA.

We receive, document, and respond to FDA inquiries on your behalf, ensuring timely, accurate, and compliant communication. 

We support you during FDA inspections, notification requests, and documentation reviews to help you reduce risks.

We provide a valid U.S.-based contact for your FDA records, as required for foreign manufacturers entering the U.S. market.

We maintain, update, and renew your FDA registrations each year so your operations remain uninterrupted.

We help collect, review, and manage the documents required for regulatory correspondence, including product details, labeling, and safety data. 

We advise on additional compliance needs such as labeling rules, claims, import requirements, and product pathway considerations.

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FSVP Agent Services

We help determine whether you are subject to full or modified FSVP requirements and guide you through the steps to qualify your business.

We assess the food safety performance and compliance history of your foreign suppliers, including preventive controls, allergen controls, and GMP.

We support you and your foreign suppliers in developing complete and compliant FSVP plans, including required verification activities.

We conduct or review hazard analyses to identify potential food safety risks and determine their likelihood and severity.

We verify foreign supplier practices to ensure they meet FDA expectations for human and animal foods.

We organize, maintain, and update your FSVP documentation, safety plans, and verification records for FDA review.

We review your supplier’s food safety certifications and help manage renewals as part of your ongoing FSVP responsibilities.

We can act as your FSVP Importer if you have no U.S. owner or consignee listed at the time of import.

We help you prepare for FDA inspections and assist in responding to any follow-up questions or requests.

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U.S. Agent vs FSVP Agent: Which One Do You Need?

Choosing the right type of FDA representation depends on what you import and how your products enter the U.S. market. We can help you understand where your business fits. 

When a U.S. Agent is the right fit

  • You operate a foreign facility that must register with the FDA. 
  • Your products fall under categories such as medical devices, OTC drugs, cosmetics, dietary supplements, or food. 
  • You need a U.S. contact for inspection scheduling and FDA communication. 

When an FSVP Agent is the right fit

  • You import food, beverages, ingredients, dietary supplements, or pet foods. 
  • There is no U.S. owner or consignee listed on your shipment. 
  • You need to meet FSMA requirements related to supplier verification and importer responsibilities. 

When you may need both

Some businesses require both roles. For example, a foreign dietary supplement manufacturer shipping directly to the U.S. may need a U.S. Agent for FDA registration and an FSVP Agent to meet importer obligations. 

Industries We Support

We support a wide range of regulated industries through our U.S. Agent and FSVP Agent solutions, including: 

Food and beverages

Dietary supplements

Cosmetics

Medical devices

OTC drugs

Ingredients

Pet foods

Why Work With Quality Smart Solutions

Experience acting as both FDA U.S. Agent and FSVP Agent for global brands.
Support from former FDA professionals and certified specialists.
Knowledge across labeling, registrations, supply chain documentation, and FSVP.
Support for both first-time U.S. market entry and ongoing importers.

Explore More Resources

FSMA Assurance

How FSMA Strengthens Food Safety Compliance
USA Import Services

From customs clearance to delivery: How USA Import Services can benefit your supply chain
fsvp certificate

Building trust & credibility in your food business with a FSVP Certificate

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