What Is an FEI Number? Everything You Need to Know

If your business works with FDA-regulated products—like pharmaceuticals, medical devices, food, or cosmetics—you may have heard the term FEI number. But what is it exactly, and why is it important?

This guide answers the question: “What is an FEI number?” We’ll cover its definition, purpose, who needs it, and how to obtain one.

FEI Number Definition

An FEI number, or FDA Establishment Identifier, is a unique 10-digit number assigned by the U.S. Food and Drug Administration (FDA) to track and monitor facilities involved in the manufacture, import, distribution, or testing of FDA-regulated products.

It’s used primarily for FDA inspections, compliance tracking, and regulatory correspondence.

What Does FEI Stand For?

FEI = Facility Establishment Identifier

This number helps the FDA identify facilities across different regulatory databases, regardless of registration or product type.

Who Needs an FEI Number?

You may need an FEI number if your business is involved in any of the following:

Manufacturing medical devices or pharmaceuticals
Distributing or importing FDA-regulated products
Operating a clinical research organization (CRO)
Producing food, dietary supplements, or cosmetics
Conducting FDA inspections or audits

Types of businesses that require FEI numbers:

Drug manufacturers (domestic and foreign)
Medical device firms
API suppliers
Contract laboratories
Food and beverage processors
Cosmetics producers with FDA interactions

What’s the Purpose of an FEI Number?

Track FDA inspections at a facility
Identify and link facilities in enforcement actions
Maintain consistent records across registration systems
Communicate regulatory status or inspection results
Help FDA coordinate international oversight and safety

Think of the FEI number as the social security number for FDA-regulated facilities.

FEI Number vs FDA Registration Number: What’s the Difference?

Feature	FEI Number	FDA Registration Number
Purpose	Facility identification by FDA	Registers a facility with FDA
Assigned By	FDA Office of Regulatory Affairs	Based on annual registration process
Format	10-digit number	Varies by industry (not standardized)
Use Case	Inspections, compliance	Legal operation under FDA regulations
Changes Annually?	No (fixed)	Yes (must renew annually)

In summary: An FEI number is permanent and tied to your facility. A registration number may change each year and is tied to product registration status.

How to Get an FEI Number

Option 1: Through FDA Registration

If you’ve already registered your facility (e.g., medical device registration or drug establishment registration), the FDA typically assigns an FEI number automatically.

You can check your status in:

FDA’s FURLS (FDA Unified Registration and Listing System)
Device Registration and Listing database
Drug Establishments Current Registration Site (DECRS)

Option 2: Request It Directly

If you need your FEI number and can’t find it:

Submit a request to FEI_Request@fda.hhs.gov
Include your business name, DUNS number (if available), and address
The FDA typically responds within 1–2 weeks

Where to Look Up an FEI Number

FDA FEI Search Portal: Some public databases list FEI numbers associated with devices and drugs.
FDA Establishment Inspection Reports (EIRs): Often contain FEI references.
Your registration confirmation email from FDA (for registered entities)

Tip: Always store your FEI number securely—it will be used in future inspections, audits, and correspondence.

Why FEI Numbers Matter for International Companies

If you’re a foreign manufacturer exporting to the U.S., the FDA uses your FEI number to:

Track imports and shipments
Assign inspectors for foreign audits
Ensure U.S. supply chain transparency

Many international firms must provide their FEI when:

Registering with the FDA
Submitting premarket approvals (e.g., 510(k), NDA)
Applying for a U.S. agent designation

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Conclusion

So, what is an FEI number? It’s a unique identifier used by the FDA to monitor and track facilities that manufacture, distribute, or test regulated products. Unlike a registration number, your FEI number doesn’t change annually and plays a critical role in compliance and inspections.

If you work in pharmaceuticals, medical devices, food, or cosmetics, knowing your FEI number is essential for regulatory success.

FAQs

1. Is an FEI number the same as a DUNS number?

No. A DUNS number is issued by Dun & Bradstreet for business identification, while an FEI number is issued by the FDA for facility tracking.

2. Do all FDA-regulated companies need an FEI number?

Only facilities that are inspected or registered with the FDA typically receive one. It’s not required for retail outlets or indirect suppliers.

3. How long does it take to receive an FEI number?

If assigned automatically via registration, you’ll receive it instantly. If you request it manually, the FDA typically responds within 7–10 business days.