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US FDA Agent Service

All foreign establishments that manufacture food, drug, medical device, or cosmetic products for the U.S. market must designate a U.S. FDA Agent. LMG provides FDA Agent services for establishments in 150+ countries.

All Product Categories150+ CountriesImmediate Designation

U.S. FDA Agent Services — What LMG Provides

LMG serves as your official U.S. FDA Agent — the legally required point of contact between your foreign facility and the FDA.

U.S. Agent Designation

LMG is designated as your official U.S. FDA Agent — fulfilling the mandatory regulatory requirement for all foreign food, drug, device, and cosmetic establishments.

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FDA Communication Relay

We receive and relay all FDA communications, inquiries, and inspection notices to your facility promptly — ensuring you never miss a critical FDA message.

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Prior Notice Assistance

For food importers, we assist with FDA Prior Notice submission — required before any food shipment arrives at a U.S. port of entry.

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Regulatory Support

We provide ongoing regulatory guidance as your FDA Agent — helping you understand and respond to FDA requests, import alerts, and compliance communications.

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Registration Certificate

LMG issues an FDA Registration Certificate to all our clients — verifiable by importers and customs brokers on our website. which confirms your facility's active FDA registration status and compliance.

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All Product Categories

We serve as U.S. FDA Agent for food, drug, API, medical device, and cosmetic establishments — a single point of contact for all your FDA regulatory needs.

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How the U.S. FDA Agent Designation Works

We manage the entire process from start to finish — so you can focus on your business.
1

Registration Form

You complete our simple registration form identifying your facility and product category.
2

Agent Update

We review your information and update your FDA registration with LMG as your official U.S. Agent.
3

Immediate Activation

Your U.S. Agent designation is active immediately — LMG becomes your official FDA contact.
4

Ongoing Service

We monitor FDA communications and relay all messages to your facility throughout the year.

Frequently Asked Questions

Common questions about this FDA regulatory service.

Yes. All foreign food, drug, medical device, and cosmetic establishments must designate a U.S. FDA Agent as a mandatory part of their FDA registration.

The U.S. Agent receives all FDA communications on behalf of the foreign establishment — including inspection notices, import alerts, and regulatory inquiries — and relays them to the facility.

The U.S. Agent must be physically located in the United States and available during U.S. business hours. LMG is headquartered in Aurora, Illinois and fully meets this requirement.

LMG can be designated as your U.S. Agent immediately upon completion of our agreement and registration form — the same day in most cases.

Need a U.S. FDA Agent?

LMG provides U.S. FDA Agent services for foreign establishments in 150+ countries across all FDA product categories.

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