Question 1

How can I get my food facility registered with the FDA — and what steps should I follow?

Accepted Answer

Let’s get started with your FDA Registration
The first thing you’ll need is a DUNS number — it’s a unique identifier for your facility and required by the FDA.

Already have one? Great! You’re ready for the next steps.

Still need a DUNS number? No problem — click here to learn how to get one and we’ll guide you through it. 
https://www.grf-chb.com//s/f/what-documents-do-i (https://www.grf-chb.com//s/f/what-documents-do-i)

How do I begin my FDA registration?
To get started, simply complete your payment in full. As soon as it’s processed, we’ll send you a secure password so you can access the FDA registration form without delay.
If you have any questions or need help with the payment process, we’re here for you — just reach out and we’ll guide you every step of the way.

How do I complete the FDA registration form?
No worries, we’re here to make it simple. Once you receive access to the form, just take your time filling it out completely. Every section matters, so be sure to review each part carefully and provide all the requested details. If you’re unsure about anything — whether it’s a technical term or what a section is asking for — reach out to us. We’ll walk you through it step by step so you can feel confident moving forward.

Where do I send my completed FDA registration form?
Once you’ve filled out the form completely, just email it to us at customs@grf-chb.com. Sending it promptly helps us get started right away, so your registration stays on track.
If you have any questions before submitting — even small ones — we’re here to help. Reach out anytime, and we’ll make sure everything’s good to go.

Still have questions?
We’re just a call or click away. Reach out to us anytime at customs@grf-chb.com or give us a call at +1 786-716-7391 — we’re happy to help.

Ready to move forward?
Take the next step toward compliance and peace of mind. Register your food facility today and set your business up for long-term success. With GRF by your side, you’re never navigating regulations alone.

Question 2

What is a DUNS Number & Why do businesses need one?

Accepted Answer

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The DUNS number is a unique nine-digit identifier provided by D&B that serves as a universal business identifier and is widely used by companies and organizations worldwide. It helps establish the credibility and legitimacy of a business entity and facilitates transactions with suppliers, customers, and financial institutions. Having a Dun & Bradstreet (DUNS) number is important for FDA registration and compliance for several reasons:

Identification and Verification:
Verification: The FDA uses the DUNS number as a unique identifier to accurately identify and verify facilities during the registration process. This helps ensure that the correct information is associated with each facility and facilitates effective communication between the FDA and regulated entities.

Regulatory Compliance:
FDA regulations require facilities engaged in manufacturing, processing, packing, or holding food products for consumption in the United States to register with the agency. The DUNS number is one of the key pieces of information required for FDA registration. Without a DUNS number, facilities may encounter difficulties or delays in completing the registration process and maintaining regulatory compliance.

Enhanced Transparency and Accountability:
The use of DUNS numbers enhances transparency and accountability in the regulatory process by providing a standardized method for tracking and monitoring facilities across different regulatory agencies and jurisdictions.

Overall, having a DUNS number is a critical aspect of FDA registration and compliance for facilities involved in the production, processing, packing, or holding of food products intended for consumption in the United States.  It helps ensure accurate identification, regulatory compliance, transparency, and effective communication between the FDA and regulated entities, ultimately contributing to the safety and integrity of the U.S. food supply.

If you would like to obtain a DUNS number, please click the link below for how-to information:
https://www.grf-chb.com//s/f/what-documents-do-i (https://www.grf-chb.com//s/f/what-documents-do-i)

Question 3

What documents do I need to obtain a DUNS number?

Accepted Answer

Need a DUNS Number for FDA Registration? We’ve Got You Covered.

If you're registering your food facility with the FDA, you'll need a DUNS number — and we’re here to help you get it, step by step.

At GRF, we make the process simple and stress-free. All we need from you are two documents that confirm your business name and physical address. Once we have those, we’ll handle the rest.

What kind of documents do I need?
Your documents must match your legal business name and current physical address.
If you’re a sole proprietor, the documents should reflect your full legal name and address.
Please do not send personal documents like driver’s licenses, passports, Social Security numbers, or bank statements.

Here are examples of accepted documents:
 • Secretary of State Articles of Incorporation
 • Secretary of State Receipt of Filing
 • Taxpayer Identification Number (TIN) Confirmation Letter
 • Employer Identification Number (EIN) Confirmation Letter
 • DBA / Assumed Name Certificate Filing
 • Lease Agreement or Mortgage
 • Phone, Internet, or Utility Bill
 • Homeowners or Renters Insurance
 • City or State Tax Permit
 • Invoice from a third party
 • Proof of Insurance

Once you’ve gathered your two documents, simply email them to us at customs@grf-chb.com. We’ll take it from there — keeping you informed every step of the way.

Question 4

What is a US FDA Agent and why do I need one?

Accepted Answer

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“Any foreign establishment engaged in the manufacture, preparation, propagation, compounding, or processing of a device imported into the United States must identify a United States agent (U.S. agent) for that establishment.”(https://www.fda.gov/medical-devices/device-registration-and-listing/us-agents)

Having a U.S. Agent for FDA matters is crucial for foreign companies seeking to comply with FDA regulations, maintain communication with the FDA, and navigate the regulatory landscape in the United States.

Communication Bridge
The U.S. Agent serves as a communication liaison between the FDA and the foreign company. They receive communications from the FDA on behalf of the foreign company and ensure that important information, such as regulatory updates or inspection notifications, is promptly relayed to the company.

Accessibility
The presence of a U.S. Agent ensures that the FDA can easily reach out to a representative within the United States if needed. This facilitates smoother communication and interaction between the FDA and the foreign company, which is especially important in cases of urgent matters or regulatory compliance issues

Local Representation
In the event of regulatory enforcement actions or inspections by the FDA, having a U.S. Agent provides the foreign company with a designated representative in the United States. This can be beneficial for handling any regulatory issues or inquiries that arise, as the U.S. Agent can help facilitate communication and resolution with the FDA

Requirement
For foreign companies that are required to register with the FDA, designating a U.S. Agent is often mandatory. This requirement is outlined in various FDA regulations, such as the Food Safety Modernization Act (FSMA) and the Federal Food, Drug, and Cosmetic Act (FD&C Act), to ensure that foreign companies have a point of contact within the United States for regulatory purposes

Question 5

What is the Foreign Supplier Verification Program (FSVP)?

Accepted Answer

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FSVP, or Foreign Supplier Verification Program, is a crucial component of the FDA's Food Safety Modernization Act (FSMA), designed to ensure that food imported into the United States is safe for consumption. 
 
There are several benefits for a supplier to comply with FSVP:

Access to U.S. Market
Compliance with FSVP is mandatory for foreign suppliers who want to export food products to the United States. By adhering to FSVP requirements, suppliers gain access to a significant market and expand their business opportunities.

Improved Reputation and Trust
Compliance with FSVP demonstrates a supplier's commitment to food safety and quality. This can enhance their reputation among consumers, retailers, and other stakeholders, fostering trust in their products and brand.

Competitive Advantage
Suppliers who comply with FSVP may gain a competitive advantage over those who do not. Compliance demonstrates professionalism, reliability, and a willingness to meet the highest food safety standards, which can differentiate them in the marketplace.

Enhanced Food Safety Standards
Implementing FSVP helps suppliers improve their food safety practices and standards. This not only ensures compliance with U.S. regulations but also enhances the overall safety and quality of their products, benefiting both domestic and international consumers.

Reduced Risk of Recalls and Legal Issues
By implementing robust food safety measures and complying with FSVP requirements, suppliers can reduce the risk of contamination incidents, recalls, and legal issues. This helps safeguard their business interests and avoids potential financial losses.

Facilitated Trade Relationships
Compliance with FSVP requirements can streamline trade relationships with U.S. importers and distributors. Suppliers who have established FSVP systems in place are more likely to attract reputable partners and build long-term, mutually beneficial trade relationships.

Overall, having an FSVP as a supplier brings numerous benefits, including market access, enhanced food safety standards, improved reputation, reduced risks, competitive advantage, and facilitated trade relationships.

Please visit the electronic Code of Federal Regulations on the subject at
eCFR :: 21 CFR Part 1 Subpart L -- Foreign Supplier Verification Programs for Food Importers(https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-1/subpart-L)