How to Check US FDA Registration Online: Complete Verification Process

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Before importing, distributing, or sourcing FDA-regulated products, it is essential to confirm whether a facility is registered with the U.S. Food and Drug Administration (FDA). Checking US FDA registration is a standard regulatory due-diligence activity used by manufacturers, importers, distributors, and compliance professionals to verify that establishments have fulfilled mandatory registration and listing requirements.

Knowing how to check US FDA registration correctly helps prevent business with non-compliant suppliers and reduces regulatory and commercial risk.

What Is Considered US FDA Registration?

US FDA registration generally refers to establishment registration, which is required for facilities that manufacture, process, pack, or label FDA-regulated products, including:

Drug products
Medical devices
Food and beverages
Dietary supplements
Cosmetics

Registration confirms that a facility has notified FDA about its operations.

Important clarification:
FDA registration is not FDA approval. Registration is an administrative compliance requirement, while approval (when applicable) is a separate regulatory pathway.

Why You Should Verify FDA Registration Status

Companies routinely check FDA registration to:

Confirm supplier or manufacturer legitimacy
Support import and export compliance
Reduce risk of regulatory enforcement
Verify readiness before commercial agreements

Failure to verify registration is one of the most common causes of shipment holds and compliance issues.

Where US FDA Registration Can Be Checked

The FDA provides public online databases that allow users to search registered establishments and listed products. These systems contain current records for:

Drug manufacturing establishments
Medical device manufacturers
Food facilities
Other FDA-regulated establishments

The databases are updated regularly and reflect registration status based on annual renewals.

Step-by-Step: How to Check US FDA Registration

Step 1: Open the FDA Registration & Listing Search System

Access the FDA’s official registration and listing database.

Step 2: Select Your Search Method

You may search using:

Company or establishment name
Address or country
Registration number (if available)

Step 3: Enter Search Information

Type the available details and submit the search.

Step 4: Review the Results

Search results typically show:

Establishment name
Company name
Address and country
Registration status

If the establishment appears in results, registration has been completed.

How to Understand the Results

When reviewing results, remember:

Listed facility = registered, not approved
Registration must be renewed every year
Status may appear as active or inactive

If a facility does not appear, possible reasons include missed renewal, incomplete registration, or incorrect search inputs.

How to Check Drug Product Listing

For drug products, FDA drug listing databases can be searched separately. Drug listing records may display:

Drug name
Dosage form and strength
Labeler name
National Drug Code (NDC)

Drug listing confirms submission of product information by a registered establishment. It does not confirm FDA approval.

Common Misunderstandings

Many users incorrectly believe that:

Registration means FDA approval
Registration is permanent
All products from registered facilities are FDA-approved

Understanding these differences is essential for accurate compliance decisions.

What to Do If You Cannot Find a Registration

If you cannot locate a facility or product:

Re-check spelling and details
Try alternative search terms
Ask the company to confirm its registration or renewal

If uncertainty remains, professional regulatory review may be required.

Why Professional FDA Verification Support Matters

Although FDA databases are public, interpreting results correctly requires regulatory expertise. Misinterpretation can lead to shipment delays, import refusal, or enforcement action.

XPRO America, a US FDA Consultancy, provides FDA registration verification, establishment registration, drug listing, US Agent services, and ongoing compliance support for companies worldwide.

For assistance with FDA registration checks or regulatory verification, contact support@xproamerica.com.

Conclusion

Knowing how to check US FDA registration online is a fundamental part of regulatory due diligence. By using FDA databases properly and understanding what registration represents, companies can make informed decisions and protect their supply chains.

Working with an experienced US FDA Consultancy ensures accurate verification and reliable compliance outcomes.