FDA Establishment Identifier (FEI) Number: Complete Guide for FDA Registration, Imports, Inspections, and Compliance

Introduction: Why the FEI Number Matters

The U.S. FDA regulates a wide range of products sold, imported, manufactured, processed, packed, labeled, relabeled, repackaged, stored, or distributed for the United States market. To manage such a large regulatory system, the FDA uses facility identifiers to distinguish one establishment from another. One of the most important identifiers is the FDA Establishment Identifier, known as the FEI Number.

An FEI Number is a unique facility identifier assigned by the FDA to an establishment involved with FDA-regulated products. It may be used by the agency to track inspections, compliance history, import reviews, product submissions, establishment registrations, user fee payments, and other regulatory activities. For foreign manufacturers and exporters, the FEI Number can become especially important when products are shipped to the United States and reviewed by FDA at the border.

Many companies confuse the FEI Number with other identifiers, including FDA registration numbers, Food Facility Registration numbers, DUNS Numbers, Employer Identification Numbers, tax IDs, and import account numbers. These identifiers may all appear in regulatory, customs, or business records, but they do not serve the same purpose. Using the wrong number in the wrong place can delay submissions, create import holds, or cause confusion during FDA communications.

This article explains what an FEI Number is, who may need one, how it is used, how to search for an existing FEI, how to request assistance, and why the FEI should be part of a company’s FDA compliance file.

Chapter 1: What Is an FDA Establishment Identifier Number?

An FDA Establishment Identifier Number is a unique identifier assigned by the U.S. Food and Drug Administration to a facility or establishment. It helps FDA recognize a specific physical location in its internal firm inventory and regulatory systems. The establishment may be domestic or foreign, and it may be involved in activities such as manufacturing, processing, packing, holding, labeling, relabeling, repackaging, sterilizing, importing, distributing, or otherwise handling FDA-regulated products.

The FEI is not a marketing approval, license, certificate, or guarantee of compliance. It is an identifier. Having an FEI Number does not automatically mean that a product is FDA approved, FDA cleared, legally marketed, properly labeled, or eligible for import. Instead, the FEI allows FDA to connect a facility to regulatory records and activities.

For example, if FDA inspects a facility, the inspection may be associated with the facility’s FEI. If a drug establishment registers, the FEI may be connected to the establishment registration. If a medical device establishment pays a user fee or submits registration information, the FEI may help identify the correct firm. If an importer submits an FDA-regulated shipment through U.S. Customs and Border Protection, the FEI may assist the FDA’s import review process.

Chapter 2: When You May Need to Reference an FEI Number

Companies may need to reference an FEI Number in several FDA-related situations. The exact requirement depends on the product category, regulatory activity, and type of establishment involved. In many cases, the FEI helps FDA match the company’s submission, registration, import entry, or communication to the correct physical location.

• FDA communications regarding inspections, compliance issues, registration questions, or import matters.
• Medical device submissions, including Premarket Notification 510(k), Premarket Approval applications, and related establishment records.
• Drug submissions, including Drug Master Files, Investigational New Drug applications, New Drug Applications, and establishment registration records.
• Import or export documentation for FDA-regulated products offered for entry into the United States.
• Annual reports, establishment registration renewals, product listing records, and user fee records.
• Cosmetic facility registration and product listing activities under the Modernization of Cosmetics Regulation Act of 2022.

Because the FEI is used across multiple FDA systems, maintaining the correct number in your compliance records is essential. A facility with multiple names, former addresses, old registration records, or a history of mergers and acquisitions may have more than one confusing record in FDA systems. Before submitting important documentation, companies should verify that the correct FEI is associated with the correct physical address.

Chapter 3: FEI Number Versus FDA Registration Number

One of the most common mistakes is assuming that an FEI Number and an FDA registration number are the same. They are not. An FDA registration number may be issued as part of a specific registration program, such as food facility registration, drug establishment registration, medical device establishment registration, or another FDA system. An FEI Number is a facility identifier used by FDA to identify the establishment itself.

For food facilities, the Food Facility Registration number is connected to the food facility registration system and requires renewal during the FDA’s biennial renewal period. The FEI, by contrast, is generally tied to the physical facility location and does not expire in the same way. If the facility changes address, ownership, or operations, the company should review whether registration records and facility identifiers remain accurate.

The FEI is also different from an Employer Identification Number, or EIN. An EIN is a federal tax identification number used by the Internal Revenue Service to identify a business entity for tax purposes. The FEI is an FDA identifier and is not used as a tax ID. A company may have an EIN, a DUNS Number, an FDA registration number, and an FEI Number, but each has a different purpose.

Chapter 4: FEI Numbers for Food Facilities

Food facilities that manufacture, process, pack, or hold food for consumption in the United States may need to register with the FDA unless an exemption applies. Once a food facility completes its initial registration, FDA may assign an FEI Number to the facility. The timing can vary. In many cases, the FEI is assigned after registration and may take several business days or longer to appear in FDA systems.

Food companies should understand that the Food Facility Registration number and the FEI are different. The registration number relates to the facility’s food registration status. The FEI is a facility identifier used by FDA to track the establishment. Both may be relevant in FDA communications and import entry review.

Foreign food facilities exporting to the United States should also remember that food facility registration is only one part of U.S. compliance. Products may also require FDA-compliant labels, Prior Notice, Foreign Supplier Verification Program compliance by the U.S. importer, acidified or low-acid canned food filings, seafood HACCP, juice HACCP, dietary supplement GMP compliance, or other product-specific requirements.

Chapter 5: FEI Numbers for Drug Establishments

Drug establishments are among the most heavily regulated FDA facility types. Domestic and foreign establishments engaged in manufacturing, preparing, propagating, compounding, processing, repackaging, or relabeling drug products for the U.S. market may be required to register with FDA and list commercially marketed drug products.

Under Section 510 of the Federal Food, Drug, and Cosmetic Act, drug establishment registration includes facility identity information. The Unique Facility Identifier requirement is especially important, and FDA has identified the DUNS Number as a preferred UFI. The FEI may also be used in drug establishment records, inspection history, user fee matters, import screening, and submission-related communications.

Drug companies should not treat an FEI Number as evidence that a drug product is legally marketed. Drug products may require proper listing, compliant labeling, National Drug Code assignment, compliance with current good manufacturing practice, and in many cases an approved application or applicable OTC monograph compliance. A correct FEI helps identify the facility, but it does not solve product classification or drug approval questions.

Chapter 6: FEI Numbers for Medical Device Establishments

Medical device establishments that manufacture, prepare, propagate, assemble, or process devices intended for commercial distribution in the United States may be required to register annually with FDA. Device firms may also need to list devices, pay annual establishment registration user fees, and comply with quality system requirements, labeling rules, Unique Device Identification requirements, and premarket submission obligations where applicable.

The FEI Number is important because it may connect the device establishment to registration, listing, inspection, import, and submission activities. Companies may need to reference the FEI in connection with 510(k) submissions, Premarket Approval applications, user fee records, or FDA communications. Foreign device establishments may also need a U.S. Agent and may be connected to importers, initial importers, specification developers, contract manufacturers, sterilizers, relabelers, or repackagers.

Medical device import entries can be delayed when manufacturer, shipper, importer, product code, listing, registration, or FEI information does not match FDA records. For this reason, device companies should maintain a clean regulatory identity file containing the legal name, physical address, FEI, DUNS Number, registration number, owner/operator information, U.S. Agent information, and device listing records.

Chapter 7: FEI Numbers for Cosmetic Establishments Under MoCRA

The Modernization of Cosmetics Regulation Act of 2022 changed the compliance landscape for cosmetic companies. Cosmetic manufacturers and processors may now need to complete FDA cosmetic facility registration and product listing, unless an exemption applies. As part of this process, the FEI Number has become an important identifier for cosmetic establishments.

Cosmetic companies that previously operated with limited FDA interaction may now need to understand facility identifiers, responsible person obligations, product listing, adverse event recordkeeping, safety substantiation, labeling, fragrance allergen disclosure planning, and good manufacturing practice expectations. The FEI Number helps FDA identify the cosmetic establishment, but it does not replace MoCRA compliance obligations.

Foreign cosmetic manufacturers exporting to the United States should verify their facility identity before submitting registration information. A mismatch in facility name or physical address can create avoidable delays. Companies should also ensure that their U.S. business partners, distributors, marketplaces, and importers use consistent establishment information in commercial records.

Chapter 8: How to Search for an Existing FEI Number

If your facility is already in FDA’s firm inventory, you may be able to look up its FEI Number through FDA search resources. The FEI Portal allows users to look up and verify FEI information for certain firms already in FDA systems. Search results may display the firm’s FEI, firm name, physical address, and mailing address.

The FEI Portal can help identify FEI numbers associated with a specific address or identify the address associated with a specific FEI. Users may need to create an account and log in to access the search function. Search limits may apply, and not all FEIs are searchable because some information may not be considered releasable.

When searching for an FEI, use the firm’s complete legal name and full physical address. Avoid relying only on brand names, trade names, abbreviations, warehouse names, or old addresses. If a company has moved, changed ownership, or changed its legal name, additional verification may be needed.

Chapter 9: What to Do If an FEI Is Not Found

If an FEI is not returned in a search, it does not always mean that the facility has no FEI. The facility may not be searchable in the public tool, the address may be entered differently, the name may be recorded differently, or the FEI may not yet have been assigned. In some cases, the company may need to use other FDA resources depending on product type.

For drug establishments, FDA drug establishment registration resources may help verify establishment information. For medical device establishments, FDA device registration and listing resources may help confirm whether a facility appears in the relevant system. For food facilities, the FEI may be assigned after the initial food facility registration process.

If the number is still not found, companies may request assistance from a qualified FDA compliance consultant or service provider. A manual review should include the facility’s legal name, full physical address, product category, registration history, owner/operator information, DUNS Number, and any previous FDA correspondence.

Chapter 10: FEI Number and FDA Import Entries

Products regulated by the FDA are subject to agency review when offered for entry into the United States. FDA-regulated import entries are submitted through U.S. Customs and Border Protection systems and electronically reviewed by FDA. The agency uses entry data to determine whether a product may proceed, requires further review, must be examined, needs documentation, or may be subject to detention or refusal.

Accurate firm information is essential. The manufacturer, shipper, importer, owner, consignee, product description, product code, country of origin, registration numbers, listing data, and facility identifiers must be consistent. The FEI may help FDA identify the correct firm in the import message set. If the wrong firm or wrong address is used, the entry can be delayed or flagged for review.

Importers, customs brokers, and foreign exporters should coordinate before shipment. The exporter should provide the correct legal facility name, physical address, FEI if available, FDA registration number where applicable, product label, invoice, packing list, certificate of analysis where relevant, and any required prior notice or listing information. Waiting until a shipment is already on the water or already detained at the border can make corrections more difficult.

Chapter 11: FEI Number, DUNS Number, and Unique Facility Identifier Requirements

The DUNS Number is an important business identifier assigned and managed by Dun & Bradstreet. FDA has used the DUNS Number as a preferred Unique Facility Identifier in certain registration contexts. A DUNS Number may be required or strongly expected for drug, medical device, cosmetic, and food facility registration activities, depending on the applicable FDA system and requirement.

The FEI and DUNS Number serve different purposes. The DUNS Number is used to verify the business or facility identity through a third-party business database. The FEI is assigned by FDA and used in FDA systems. Many companies need both. Before starting a registration, the company should verify that its DUNS record matches the exact legal name and physical address that will be used in FDA registration.

A mismatch between the DUNS address, FDA registration address, FEI record, and commercial documents may cause delays. This is especially common with foreign companies using translated addresses, export offices, factory addresses, warehouse addresses, or parent-company names. The safest approach is to maintain one consistent facility identity file and use it across FDA submissions, customs documents, certificates, and marketplace compliance records.

Chapter 12: Common FEI Mistakes to Avoid

FEI-related problems are often caused by inconsistent company information. A company may register under one legal name, ship products under another name, use a brand name on the commercial invoice, and provide a warehouse address instead of the manufacturing facility address. This can make it difficult for FDA to match the entry or submission to the correct establishment.

• Using the FDA registration number when the FEI Number is requested.
• Confusing the FEI Number with an EIN or tax identification number.
• Using a mailing address instead of the physical facility address.
• Using a brand name instead of the legal establishment name.
• Submitting registration information before correcting DUNS address mismatches.
• Assuming that an FEI means a product is FDA approved or FDA cleared.
• Failing to provide the FEI to customs brokers handling FDA-regulated entries.
• Not updating internal compliance records after a facility move, ownership change, or name change.

Companies should train regulatory, logistics, export, and sales teams on the difference between facility identifiers and product approvals. This helps prevent marketing claims such as “FDA certified” or “FDA approved facility” when those claims are not accurate.

Chapter 13: FEI Number Checklist for Domestic and Foreign Companies

Before starting an FDA registration, renewal, import shipment, or submission, companies should prepare a facility identity checklist. This checklist helps prevent avoidable delays and makes communication with consultants, brokers, U.S. Agents, importers, and FDA more efficient.

• Full legal company name exactly as used in corporate and regulatory records.
• Complete physical facility address, including street, city, state or province, postal code, and country.
• Mailing address, if different from the physical address.
• DUNS Number and confirmation that the DUNS address is accurate.
• Existing FEI Number, if already assigned or located.
• FDA registration number, if already registered in a relevant FDA system.
• Owner, operator, parent company, or responsible official information.
• U.S. Agent information for foreign establishments where required.
• Product categories handled by the facility.
• Previous FDA correspondence, inspection records, import holds, or warning letters, if applicable.

Chapter 14: FEI Number and FDA Compliance Strategy

The FEI Number should be treated as part of a broader FDA compliance strategy. It belongs in the company’s regulatory master file, along with registration records, product listings, labels, certificates, standard operating procedures, supplier records, quality records, and import documentation. When the company expands into new product categories, the FEI may remain relevant, but new regulatory obligations may apply.

For example, a company that manufactures cosmetics and later begins manufacturing OTC drug products cannot rely on cosmetic registration alone. A food facility that begins producing dietary supplements may need to comply with dietary supplement current good manufacturing practice. A device manufacturer that modifies its intended use or technology may need to evaluate whether a new premarket submission is required.

In other words, the FEI identifies the establishment, but the company still needs a complete compliance program based on the product category, claims, ingredients, labeling, manufacturing operations, and U.S. distribution model.

Conclusion: Keep Your FEI Records Accurate Before Problems Occur

The FDA Establishment Identifier Number is a key part of FDA facility identity management. It helps FDA connect an establishment to inspections, registrations, submissions, user fees, import entries, and compliance records. For domestic and foreign companies, especially those exporting FDA-regulated products to the United States, the FEI can help prevent confusion when dealing with FDA, customs brokers, U.S. importers, Amazon warehouses, distributors, and marketplace compliance teams.

However, an FEI Number is not a substitute for FDA compliance. It does not approve a product, clear a device, list a drug, register a food facility, or guarantee that an import entry will be released. It must be used together with accurate registration records, compliant labeling, correct product classification, proper documentation, and a reliable import strategy.

The best time to verify your FEI is before submitting an FDA registration, before paying user fees, before filing a product listing, before submitting a 510(k), NDA, IND, PMA, or DMF, and before shipping products to the United States. A clean facility identity file can save time, reduce delays, and support stronger FDA compliance.