Willow Glen Proudly Offers:

$279 USD FDA Food Facility & Medical Facility Registration & FDA US Agent

FSVP Agent service

USDA VS 16-3 Import Permit Application Service

$400 USD FDA Cosmetics Registration - Modernization of Cosmetics Regulation Act of 2022 (MoCRA)

FDA Certificate of Registration

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Useful link:

Initial Importer Service for Medical device.
FSVP Plan for Food Industry.
FSVP Importer and FSVP Agent for foreign supplier.
Step-by-Step Guide to Submit a Prior Notice
What Types of Companies Offer Importer of Record (IOR) Services?
FDA Cosmetic Registration & Product Listing

Willow Glen FDA registration & certification!

Thank you for visiting our website.

Located in the beautiful San Diego County, Willow Glen Consultancy LLC is focused in FDA regulation services. We have 100% commitment — the guiding principles we value and follow each and every day as we work with you toward a successful future.

Our top priority is providing outstanding customer service. We pride ourselves on responding promptly to clients’ needs and providing exceptional individual and business advice and services.

We offer you a level of service that exceeds your expectations, whether you're looking for a facility registration or a complete review of label design.

We thank you for taking time to browse through our site. We hope you find useful information for you here: a list of the services we offer, contact information, specially-selected articles and much more.

Please contact us without hesitation if you have questions. Give us a call or drop us an email for more information about your need, or to make suggestions for what you'd like to see on our website. We look forward to working with you soon!

What Is a U.S. FDA Agent?

If your company is located outside the United States and plans to import food, dietary supplements, cosmetics, or medical devices into the U.S., the FDA (U.S. Food and Drug Administration) requires that you appoint a U.S. FDA Agent. But what does that mean — and why is it important?

Definition of a U.S. FDA Agent

A U.S. FDA Agent is a U.S.-based representative designated by a foreign establishment to act as the communication link with the U.S. Food and Drug Administration. The agent must either reside in the United States or maintain a physical place of business in the U.S.

This requirement applies to companies engaged in manufacturing, processing, packing, or holding FDA-regulated products intended for import into the United States.

Role and Responsibilities

The FDA Agent does not take legal responsibility for the products, but they serve a critical role in facilitating communication and ensuring compliance. Their key duties include:

Responding to FDA inquiries on behalf of the foreign company
Receiving inspection notices or emergency notifications
Assisting in Prior Notice submissions (for food products)
Being available for FDA contact during U.S. business hours

Who Needs a U.S. FDA Agent?

If your company is not located in the United States but you export any of the following to the U.S., you are required to designate a U.S. FDA Agent during registration:

Food and beverages
Dietary supplements
Medical devices
Cosmetics
Drugs (human or animal)

Why the U.S. FDA Agent Matters

Choosing the right FDA agent is more than a checkbox. A knowledgeable agent can:

Help reduce customs delays
Ensure timely responses to FDA compliance requests
Guide you through label reviews and facility registration
Act as your liaison in the case of FDA inspection

Appointing an FDA Agent

The U.S. FDA Agent is designated during the FDA registration process. This agent must confirm their appointment before the registration is considered valid.

If the agent does not respond to FDA confirmation requests, your registration may be delayed or invalidated — putting your imports at risk.

Need a Reliable U.S. FDA Agent?

Willow Glen Consultancy LLC provides trusted U.S. FDA Agent services to foreign food, cosmetic, and device manufacturers. Our team ensures smooth communication with the FDA, helps you stay compliant, and supports your U.S. market entry.

Willow Glen Proudly Offers:

​

$279 USD FDA Food Facility & Medical Facility Registration & FDA US Agent

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FDA Certificate of Registration

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Useful link:

How to search FDA Registration Number?

Initial Importer Service for Medical device.

FSVP Plan for Food Industry.

FDA Cosmetic Registration & Product Listing

Willow Glen FDA registration & certification!

What Is a U.S. FDA Agent?

If your company is located outside the United States and plans to import food, dietary supplements, cosmetics, or medical devices into the U.S., the FDA (U.S. Food and Drug Administration) requires that you appoint a U.S. FDA Agent. But what does that mean — and why is it important?

Definition of a U.S. FDA Agent

A U.S. FDA Agent is a U.S.-based representative designated by a foreign establishment to act as the communication link with the U.S. Food and Drug Administration. The agent must either reside in the United States or maintain a physical place of business in the U.S.

This requirement applies to companies engaged in manufacturing, processing, packing, or holding FDA-regulated products intended for import into the United States.

Role and Responsibilities

The FDA Agent does not take legal responsibility for the products, but they serve a critical role in facilitating communication and ensuring compliance. Their key duties include:

Responding to FDA inquiries on behalf of the foreign company

Receiving inspection notices or emergency notifications

Assisting in Prior Notice submissions (for food products)

Being available for FDA contact during U.S. business hours

​

Who Needs a U.S. FDA Agent?

If your company is not located in the United States but you export any of the following to the U.S., you are required to designate a U.S. FDA Agent during registration:

Food and beverages

Dietary supplements

Medical devices

Cosmetics

Drugs (human or animal)

Why the U.S. FDA Agent Matters

Choosing the right FDA agent is more than a checkbox. A knowledgeable agent can:

Help reduce customs delays

Ensure timely responses to FDA compliance requests

Guide you through label reviews and facility registration

Act as your liaison in the case of FDA inspection

Appointing an FDA Agent

The U.S. FDA Agent is designated during the FDA registration process. This agent must confirm their appointment before the registration is considered valid.

If the agent does not respond to FDA confirmation requests, your registration may be delayed or invalidated — putting your imports at risk.

Need a Reliable U.S. FDA Agent?

Willow Glen Consultancy LLC provides trusted U.S. FDA Agent services to foreign food, cosmetic, and device manufacturers. Our team ensures smooth communication with the FDA, helps you stay compliant, and supports your U.S. market entry.

Contact us today to appoint a responsive, experienced FDA agent for your business.

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📍 8880 Rio San Diego Drive, #800, San Diego, CA 92108 📞 +1-619-869-0249 📧 Info@WillowGlenFDA.com 🌐 www.WillowGlenFDA.com

📍 8880 Rio San Diego Drive, #800, San Diego, CA 92108
📞 +1-619-869-0249
📧 Info@WillowGlenFDA.com
🌐 www.WillowGlenFDA.com