US FDA Agent

A US FDA Agent serves as the official communication link between a foreign facility and the U.S. Food and Drug Administration (FDA), especially for emergency situations and regulatory correspondence related to registration, inspection, or compliance.

At RAPS, we are one of the most trusted and experienced US FDA Agents, supporting global manufacturers and exporters in the following industries:

Food and Beverages
Pharmaceuticals and APIs
Medical Devices
Cosmetics and Personal Care
Nutraceuticals and Dietary Supplements
Sterilization and Testing Laboratories

If you're a foreign facility exporting to the U.S., appointing a US FDA Agent is mandatory.

Industries Requiring a US FDA Agent

The appointment of a US FDA Agent is required for:

Drug manufacturers
Medical device manufacturers & exporters
Food manufacturers, packers & re-packers
Nutraceutical producers
API (Active Pharmaceutical Ingredient) manufacturers
Cosmetic manufacturers
Testing laboratories
Sterilization facilities

Key Responsibilities of a US FDA Agent

Your US FDA Agent is responsible for:

Receiving regulatory updates and notifications from the FDA
Facility registration and maintenance of account credentials
Coordinating all official communications with the FDA
Assisting with FDA inspections and compliance inquiries
Performing annual registration renewals
Verifying DUNS and FEI numbers
Updating importer and product listing information
Protecting facility login information and credentials
Issuing the Certificate of FDA Registration

Additional Services Available (on request):

Product label reviews
GMP guidance and consulting

Choosing the Right US FDA Agent

When selecting a US FDA Agent, it’s critical to choose a qualified, experienced, and legitimate partner. Keep the following in mind:

Must be a lawfully registered company in the United States
Should have proven expertise in FDA regulations across multiple industries
Must operate from a professional, commercial office space (not an individual’s home or shared desk)
Should be independent, without ties to US importers or buyers
Must actively communicate FDA regulatory updates to clients
Should be dedicated full-time to regulatory compliance, not part-time or freelance

Final Slide / Closing Statement

RAPS — Your Trusted US FDA Agent

With a global presence and a U.S.-based regulatory team, RAPS offers dependable, transparent, and expert support as your official US FDA Agent.

Expert Regulatory Guidance
Fast & Accurate Registrations
Responsive Global Support
100% Confidentiality Guaranteed

Partner with RAPS and ensure your FDA compliance journey is seamless, secure, and professionally managed.

Contact us today to get started with your registration and receive your Certificate of FDA Registration.

Ready to Appoint a Reliable US FDA Agent?

Navigating FDA regulations doesn’t have to be complicated. With RAPS as your trusted partner, you gain access to expert support, fast documentation, and ongoing compliance guidance—all backed by a global team with local presence in the USA.

We’re not just your agent—we’re your long-term regulatory partner.