Guide to U.S. FDA Food Facility Registration and Compliance

Introduction

U.S. FDA Registration of Food Facilities is the pillar of compliance for manufacturers, processors, packagers, and storers of food products under U.S. regulations. This guide dives directly into the registration requirements and process and introduces expert services, ensuring that your operations meet the standards set by the U.S. FDA.

What Is FDA Food Facility Registration?

The U.S. Food and Drug Administration (FDA) regulates food facilities under the Federal Food, Drug, and Cosmetic Act (FD&C Act). All facilities involved in the production, processing, packaging, or storage of food (including food additives, ingredients, and dietary supplements) must:

• Register with the FDA
• Renew registration every even-numbered year
• Allow FDA inspections as required by law

Who Must Register?

FDA Food Facility Registration is mandatory for:

• Food manufacturing/processing businesses (food additives, food raw materials, dietary supplements, etc.)
• Facilities (such as warehouses) for packaging and storing food.
• Foreign companies exporting food to the United States (must designate a U.S. agent)

FDA Food Facility Registration Requirements

To complete FDA registration, your facility must provide:

• DUNS number
• Facility information (name, address, and key personnel)
• Business details (parent company, trade names, and U.S. agents)
• Product information (categories and descriptions)

Food Facility Registration Process

• Verify Registration obligations: Confirm that your facility falls within the FDA’s definition of a food facility.
• Obtain a DUNS Number: The DUNS number is a 9-digit unique facility identifier.
• Prepare registration information: Collect all required factory/facility information.
• Complete the Online Registration: Use the FDA’s food facility registration portal to submit your application.
• Receive FDA Registration Number: After successful registration, obtain an FDA registration number.
• Regular Updates: To remain compliant, update your registration every two years.

Our Services for Your FDA Food Facility Registration

We provide end-to-end support to ensure your facility complies with FDA requirements:

FDA Food Facility Registration & Renewal

• Complete and submit your FDA registration application.
• Handle renewals every even-numbered year to maintain compliance.

U.S. Agent Services

• Our U.S. subsidiary can act as your official U.S. agent, serving as the emergency contact between your facility and the FDA.

DUNS Number Assistance

• Help your facility obtain a DUNS number, a mandatory requirement for FDA registration.

Compliance Support

• Provide guidance on FDA inspections and ongoing compliance requirements.

Why Choose Us?

• Expert Team: Our team of regulatory specialists and food scientists brings deep expertise in U.S. food regulations, ensuring accurate and efficient solutions.
• Proven Client Satisfaction: We have earned high praise from global clients, including Fortune 500 companies, for successfully guiding them into the Chinese market.
• Global Network: With offices worldwide and strong ties to regulatory authorities and industry organizations, we deliver localized support with a global perspective.
• End-to-End Solutions: From initial assessment to post-approval support, we offer one-stop services to ensure your product remains compliant.

Contact us today to learn how we can support your facility’s FDA registration and ongoing compliance needs.

Frequently Asked Questions (FAQs)

1. Do foreign food facilities need a U.S. agent for FDA registration?
Yes, all foreign facilities must appoint a U.S. agent to act as the emergency contact between the facility and the FDA.

2. Can traders apply for FDA registration, or is it only for manufacturers?
FDA registration is only required for food facilities (manufacturers, processors, packagers). Traders do not need to register.

3. How long is an FDA registration valid?
FDA registration does not expire but must be renewed every even-numbered year.

4. Does the FDA issue a registration certificate?
No, the FDA does not provide registration certificates. Registration confirmation is available through the FDA’s online system.