What Is a US Agent?
A US Agent is a person or organization residing in the US that provides official communication between the FDA and a foreign facility. Under FDA regulations, every FDA-registered facility located outside the US must designate a US Agent.
Duties of the US Agent
- Receive all communications from the FDA and relay them to the facility
- Be reachable 24/7 in food safety emergencies
- Communicate on behalf of the facility during FDA inspections and inquiries
- Help keep the registration information up to date
- Submit documents to the FDA when required
How to Choose a US Agent
Key criteria to consider when selecting a US Agent:
- Must reside in the US: The agent must have a physical address in the US
- Availability: Must be reachable during normal business hours and in emergencies
- Experience: Choose an experienced firm that knows FDA procedures
- Language support: An agent who can communicate in your own language is an advantage
What Happens Without a US Agent?
FDA registration cannot be completed without designating a US Agent. If your current US Agent withdraws and no replacement is designated, your FDA registration becomes invalid and your products may be detained at customs.
Conclusion
The US Agent is a critical component for every company exporting to the US. Working with a reliable and experienced US Agent keeps your FDA compliance process running smoothly.
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