Facility Registration with the FDA

January 28, 2026

FDA Regulations

Facility registration with the U.S. Food and Drug Administration (FDA) is a mandatory requirement for all companies that manufacture, process, pack, or store products intended for the U.S. market. This includes food, beverages, dietary supplements, medical devices, drugs, cosmetics, and biological products for both human and animal consumption.

The primary goal of this registration is to protect the health of U.S. consumers. Additionally, it ensures that the information of the registered facility is up to date, allowing the FDA to contact it in case of inspections or emergencies.

Below are the main steps for registering a facility with the FDA, along with the necessary requirements:

Steps for facility registration

Create an account in the FDA Unified Registration and Listing System (FURLS):
Access to this system is essential for centralizing and managing the registration and oversight of facilities under the FDA's jurisdiction, ensuring regulatory compliance across all related processes.

Obtain a Unique Facility Identifier (UFI):
This exclusive and mandatory identifier is a technical and administrative prerequisite to obtaining the formal registration of the facility.

Submit the required information:

Legal name of the company.
Facility address (this information must be accurate and match the UFI details).
Contact information of the person responsible.
Types of products manufactured or handled by the facility.

Pay applicable fees:
Not all products are subject to fees. For instance, medical devices require payment. To avoid surprises, check if your product is subject to any fees.

Appoint a U.S. Agent:
This step applies only to international companies wishing to register facilities.

Participate in the Foreign Supplier Verification Program (FSVP):
This critical program ensures that imported products comply with safety standards through a verification framework involving collaboration between stakeholders and the FDA.

Prepare for inspections and regulatory audits:
The FDA may inspect facilities to verify compliance with its requirements. Failing to meet these standards may result in warnings, import alerts, product recalls, fines, or even suspension of operations. Both the responsible contact and the U.S. Agent (for foreign companies) must stay alert to notifications from the FDA.

Renew registration periodically:
Depending on the product, renewal must be completed every two years or as required.

Who is responsible for registration?

The registration can be completed by:

The facility owner.
A responsible person designated by the owner.
An authorized representative.

It is important to note that the FDA does not issue an official certificate as proof of registration. All information is stored in the FURLS system, and a copy of the registration is considered valid for verifications at customs or within the United States.

Benefits of registering your facility

Although the primary purpose of the registration is to protect consumers, businesses also gain significant advantages by completing this process:

Enables the legal commercialization of products in the United States.
Builds trust with consumers and business partners.
Reduces the risk of market recalls.
For foreign manufacturers, the likelihood of customs detentions decreases.

Registering your facility with the FDA is a crucial step if you aim to compete in the U.S. market. This process not only ensures that your products comply with regulations but also enhances your company’s reputation and facilitates business relationships.

The information provided in this blog is general and should not be considered a definitive guide. It is recommended to consult an expert to verify whether additional documents are required to legally commercialize your product in the United States.

If you need assistance to safely and effectively meet all requirements, contact us. Our expert consultants are ready to guide you through each step of the process and ensure your registration is valid and FDA-compliant.

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Facility Registration with the FDA

January 28, 2026

FDA Regulations

Below are the main steps for registering a facility with the FDA, along with the necessary requirements:

Steps for facility registration

Create an account in the FDA Unified Registration and Listing System (FURLS):
Access to this system is essential for centralizing and managing the registration and oversight of facilities under the FDA's jurisdiction, ensuring regulatory compliance across all related processes.

Obtain a Unique Facility Identifier (UFI):
This exclusive and mandatory identifier is a technical and administrative prerequisite to obtaining the formal registration of the facility.

Submit the required information:

Legal name of the company.
Facility address (this information must be accurate and match the UFI details).
Contact information of the person responsible.
Types of products manufactured or handled by the facility.

Pay applicable fees:
Not all products are subject to fees. For instance, medical devices require payment. To avoid surprises, check if your product is subject to any fees.

Appoint a U.S. Agent:
This step applies only to international companies wishing to register facilities.

Participate in the Foreign Supplier Verification Program (FSVP):
This critical program ensures that imported products comply with safety standards through a verification framework involving collaboration between stakeholders and the FDA.

Prepare for inspections and regulatory audits:
The FDA may inspect facilities to verify compliance with its requirements. Failing to meet these standards may result in warnings, import alerts, product recalls, fines, or even suspension of operations. Both the responsible contact and the U.S. Agent (for foreign companies) must stay alert to notifications from the FDA.