How to Check US FDA Registration Online: Complete Verification Guide

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Checking whether a company, facility, or product is registered with the U.S. Food and Drug Administration (FDA) is a critical part of regulatory due diligence. Manufacturers, importers, distributors, and compliance teams regularly verify US FDA registration to confirm that establishments have met mandatory registration and listing obligations.

Understanding the correct way to check US FDA registration helps prevent working with non-compliant facilities, reduces shipment risks, and supports regulatory confidence.

What Does US FDA Registration Represent?

US FDA registration generally refers to establishment registration, which is a legal requirement for facilities involved in manufacturing, processing, packing, or labeling FDA-regulated products such as drugs, medical devices, food, dietary supplements, and cosmetics.

It is essential to understand:

FDA registration is a notification and compliance requirement
FDA registration is not FDA approval
Approval applies only to specific product categories under separate review programs

When you check US FDA registration, you are confirming whether a facility has notified the FDA and is listed in its registration database.

Why Checking US FDA Registration Is Important

Verifying registration status is important for several reasons:

Confirm supplier or manufacturer legitimacy
Support import and export compliance
Reduce regulatory and commercial risk
Validate registration before partnerships or sourcing

Many regulatory issues arise simply because companies fail to confirm registration status before doing business.

Where US FDA Registration Can Be Checked

The FDA maintains public online databases that allow users to search registered establishments and listed products. The primary system used is the FDA Registration and Listing database, which covers:

Drug establishments
Medical device manufacturers
Food facilities
Other regulated establishments

These databases are updated regularly and reflect current registration status.

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

Step 1: Access the FDA Registration Database

Go to the FDA’s official registration and listing search system.

Step 2: Select Search Criteria

You can search using:

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

Step 3: Enter Search Information

Type the available details into the appropriate fields and run the search.

Step 4: Review Results

Search results usually display:

Establishment name
Company name
Address and country
Registration status

If the facility appears, it indicates that establishment registration has been completed.

How to Interpret FDA Registration Results

When reviewing search results, keep these points in mind:

Listed facility = registered, not approved
Registration must be renewed annually
Registration status may be active or inactive

If a company does not appear in results, it may mean registration was never completed, has expired, or search details were entered incorrectly.

How to Check Drug Product Listing

For drug products, you can also search FDA drug listing databases. Drug listing records may show:

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

Drug listing confirms that product information has been submitted by a registered establishment. It does not confirm FDA approval.

Common Mistakes When Checking FDA Registration

Many users incorrectly assume:

Registration equals FDA approval
Registration is permanent
All products from a registered facility are approved

These assumptions can lead to compliance errors. Registration only confirms administrative notification.

What to Do If You Cannot Find a Registration

If you cannot locate a facility or product in FDA databases:

Re-check spelling and details
Try alternate search parameters
Confirm with the company whether registration was completed or renewed

In some cases, professional regulatory review is required to determine status.

Why Professional FDA Verification Support Matters

While FDA databases are public, interpreting results correctly requires regulatory knowledge. Misunderstanding registration status can result in shipment delays, import refusal, or enforcement risk.

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

Organizations needing assistance with FDA registration checks or regulatory verification can contact support@xproamerica.com for structured guidance.

Conclusion

Knowing how to check US FDA registration online is essential for regulatory due diligence and business risk management. By using FDA databases properly and understanding what registration does—and does not—mean, companies can make informed decisions and maintain compliance.

For complex verification needs or regulatory interpretation, partnering with an experienced US FDA Consultancy ensures accurate results and reliable compliance outcomes.