How do I find out if a company is registered with the FDA?

As of March 2024, there were over 220,000 domestic and foreign food companies registered with the U.S. Food and Drug Administration (FDA) [1.6.2]. Verifying a company's status is a critical step for due diligence, and knowing how do I find out if a company is registered with the FDA? involves using specific government databases that vary by industry.

Quick Summary

To determine if a company is registered with the FDA, you must search the correct, industry-specific public database for drugs or medical devices. Food facility registration information is not publicly available.

Key Points

• Databases Are Industry-Specific: You must use the correct FDA database for either drugs or medical devices to find registration information [1.4.1].

• Registration Is Not Approval: FDA establishment registration does not mean the FDA has approved, cleared, or authorized the facility or its products [1.4.6].

• Food Facility Data Is Private: Unlike drug and medical device data, the database of registered food facilities is not accessible to the public [1.6.2].

• Annual Renewal Is Key: Drug and medical device establishments must renew their registration annually, typically between October 1 and December 31 [1.2.1].

• Use Public Portals: The FDA provides the Drug Establishments Current Registration Site (DECRS) and the Establishment Registration & Device Listing database for public searches [1.4.3, 1.5.2].

• Third-Party Verification Exists: Services are available that can help verify registration status, which is particularly useful for non-public food facility data [1.2.1].

• FURLS is the Central System: Companies use the FDA Unified Registration and Listing System (FURLS) to manage their registration and listings electronically [1.3.8].

Understanding FDA Establishment Registration

Before diving into the search process, it's crucial to understand what FDA registration means. When a company registers its establishment (or facility) with the FDA, it is providing the agency with information about its location and the products manufactured there [1.7.6]. This registration is a mandatory requirement for establishments involved in the production and distribution of most medical devices, drugs, and food products intended for sale in the United States [1.7.2, 1.7.6].

However, it is critical to note that registration does not imply FDA approval, clearance, or authorization of the company or its products [1.4.6, 1.5.1]. The FDA does not issue registration certificates; any certificate you receive is likely from a third-party consultant [1.2.2]. Registration simply means the company has notified the FDA of its existence and is subject to FDA oversight and inspection. Product approval (like for a new drug or a high-risk medical device) is a separate, much more intensive process.

The FDA Unified Registration and Listing System (FURLS)

Many registration and listing activities are handled through the FDA's online portal, the FDA Unified Registration and Listing System, often referred to as FURLS [1.3.8]. This is the system that companies use to submit and update their information electronically [1.2.5]. While companies use FURLS to register, the public uses separate, dedicated databases to search for this information.

How to Search for FDA Registered Companies by Industry

The method for verifying a company's registration status depends entirely on the type of product it produces. The FDA maintains different databases for drugs, medical devices, and other product categories.

Drug Establishments

The FDA provides a public database for drug establishments. This database, the Drug Establishments Current Registration Site (DECRS), contains information submitted by firms that manufacture, prepare, or process drugs for commercial distribution in the U.S. [1.4.5]. The database is typically updated weekly [1.4.2].

Step-by-Step Guide:

1. Navigate to the Drug Establishments Current Registration Site (DECRS). You can find this on the FDA's website [1.4.3].
2. Use the search fields provided. You can enter the firm's name or a portion of its name to begin your search [1.4.1].
3. Analyze the results. The search will return the establishment's name, address, and the status of its registration [1.4.1]. This allows you to verify that the company has a current and active registration with the agency.

Medical Device Establishments

Similar to drugs, the FDA maintains a public database for medical device establishments. This allows the public to search for registration and listing information under the Freedom of Information Act [1.5.2].

Step-by-Step Guide:

1. Go to the Establishment Registration & Device Listing database. This can be found on the FDA's data portal, accessdata.fda.gov [1.5.5].
2. Enter your search criteria. You can search by the company name, owner/operator number, or registration number [1.4.6]. For best results, searching by a known registration number is most effective, but a company name search will also work [1.3.7].
3. Refine if necessary. The database allows you to filter by country, state, and other fields to narrow down results if you get too many hits (searches are capped at 100 results) [1.5.2].
4. Review the details. The results will show the firm's registration details and a list of the devices they have listed at that facility.

Another valuable tool is the Global Unique Device Identification Database (GUDID), which contains key device identification information for medical devices that have a Unique Device Identifier (UDI) [1.5.4]. While not a registration database, it helps identify specific devices on the market.

Food & Beverage Facilities

Verifying the registration of a food facility is different because the FDA does not make food facility registration information available to the public [1.6.2, 1.6.3]. This is to protect sensitive business information. While a company that manufactures, processes, packs, or holds food for consumption in the U.S. is required to register, you cannot look up their registration number in a public database.

So, what can you do?

• Ask the company directly: The most straightforward method is to ask the company to provide proof of its FDA registration. The owner of the facility can log into their FURLS account to access their registration details [1.6.3].
• Use Third-Party Verification Services: Some consulting firms, like Registrar Corp, offer a service to verify a food facility's registration status, often at no cost [1.2.1, 1.2.4]. These services act as an intermediary to confirm the validity of a registration.

Comparison of FDA Registration Databases

Feature	Drug Establishments (DECRS)	Medical Device Establishments	Food Facilities
Publicly Searchable	Yes [1.4.3]	Yes [1.5.2]	No [1.6.2]
Primary Search Portal	Drug Establishments Current Registration Site	Establishment Registration & Device Listing	Not applicable (private)
Searchable by	Firm Name [1.4.1]	Company Name, Registration Number, Product [1.4.6]	Not applicable
Renewal Frequency	Annually (Oct 1 - Dec 31) [1.2.1]	Annually (Oct 1 - Dec 31) [1.2.1]	Every even-numbered year (Oct 1 - Dec 31) [1.2.1]

Conclusion

Verifying if a company is registered with the FDA is a vital step in ensuring regulatory compliance within your supply chain and for consumer confidence. The process is straightforward for drug and medical device companies thanks to publicly accessible databases. For food facilities, the lack of a public database requires a more direct approach, either by requesting information from the company itself or utilizing a third-party service. Always remember that registration is a necessary first step, not a certification of quality or an endorsement by the FDA [1.4.6].

---

For an official search, visit the FDA's Device Registration and Listing Database. [1.4.1]

Frequently Asked Questions

What is the difference between FDA registered and FDA approved?

FDA registration means a company has notified the FDA of its existence and is subject to inspection. FDA approval is a separate, rigorous process where the agency has determined that the benefits of a specific product outweigh the known risks for its intended use [1.4.6, 1.5.1].

If I can't find a company in the database, does that mean it's operating illegally?

Not necessarily. The company might be exempt from registration, you could be searching in the wrong database, or you might have misspelled the name. For example, most domestic distributors of medical devices are not required to register [1.7.2]. Always try searching with partial names or other identifiers before drawing a conclusion [1.4.2].

How can I check if a food company is registered with the FDA?

You cannot check directly, as the FDA food facility registration database is not public [1.6.2]. You must ask the company for proof of registration or use a third-party verification service [1.2.1].

Does the FDA issue a certificate of registration?

No, the FDA does not issue certificates of registration. Any certificate you encounter is issued by a private, third-party firm as confirmation of a company's valid registration [1.2.2].

How often do companies have to renew their FDA registration?

Drug and medical device establishments must renew annually between October 1 and December 31. Food facilities must renew every two years (in even-numbered years) during the same period [1.2.1].

What is an FEI number?

An FEI (FDA Establishment Identifier) number is a unique identifier assigned by the FDA to track inspections and data for a specific regulated facility. You can use the FDA's FEI portal to look up a firm's FEI number [1.6.1].

Can I search for a product instead of a company?

Yes, in the medical device database, you can search by product information in addition to company name. For drugs, you can search other databases like the Orange Book for approved drug products, which is separate from establishment registration [1.6.3].