The FDA Establishment Identifier (FEI) is a unique number assigned by the US FDA to identify facilities that manufacture, process, pack, or hold regulated products, including cosmetics. Under the Modernization of Cosmetics Regulation Act (MoCRA), facility identification and traceability have become central to cosmetic regulatory compliance, making FEI numbers increasingly important for cosmetic manufacturers and processors.
Many companies ask how to obtain an FEI number. The key point to understand is that companies do not apply directly for an FEI number. Instead, the US FDA assigns an FEI number automatically when a facility is properly identified through certain regulatory interactions.
XPRO America is a professional US FDA Consultancy that assists cosmetic companies with facility registration, regulatory submissions, and FEI verification as part of comprehensive MoCRA compliance.
What Is an FEI Number
An FEI number is a unique numeric identifier used by the US FDA to:
- Identify a specific facility
- Track inspection history
- Link regulatory submissions to facilities
- Manage compliance records
Once assigned, an FEI number generally remains associated with that facility permanently, even if ownership changes.
Can You Apply Directly for an FEI Number
No.
There is no standalone application form to request an FEI number.
The US FDA assigns FEI numbers automatically when a facility becomes known to the agency through specific regulatory activities.
Common Ways an FEI Number Is Assigned
An FEI number is typically generated when:
- A facility completes cosmetic facility registration under MoCRA
- A facility submits certain regulatory registrations to the US FDA
- A facility is inspected by the US FDA
- A facility is referenced in regulatory submissions
For cosmetic companies, cosmetic facility registration is the most common pathway to FEI assignment.
Step 1: Complete Cosmetic Facility Registration
Cosmetic manufacturers and processors must register their facilities with the US FDA under MoCRA.
During this registration:
- Facility information is submitted electronically
- The US FDA reviews the data
- If the facility does not already have an FEI number, one may be created
This registration process is conducted through the US FDA’s Cosmetics Direct system.
XPRO America manages facility registration submissions and monitors FEI assignment.
Step 2: Ensure Accurate Facility Information
FEI assignment depends on accurate facility data.
Information must match:
- Legal business name
- Physical address
- Contact details
- Operational activities
Inconsistent or incomplete information may delay FEI creation.
Step 3: US FDA System Matching
The US FDA compares submitted facility information against its internal database.
- If a matching record exists, the existing FEI number is linked
- If no record exists, a new FEI number is created
Companies may not immediately see the FEI number upon submission.
Step 4: Confirm FEI Number
After registration processing:
- FEI may appear in regulatory correspondence
- FEI may be visible in confirmation records
- FEI may be provided during inspection or follow-up
XPRO America assists clients with FEI confirmation and verification.
FEI Number vs. Facility Registration
It is important to distinguish:
- FEI number = identification number
- Facility registration = legal compliance requirement
Having an FEI number does not mean a facility is registered. Both are required for compliance.
Foreign Facilities and FEI Numbers
Foreign cosmetic manufacturers exporting to the United States may also receive FEI numbers.
In addition to FEI assignment, foreign facilities must:
- Register under MoCRA
- Designate a US Agent
- Ensure products are listed
XPRO America provides US Agent services and manages compliance for foreign companies.
When You Might Not Yet Have an FEI Number
You may not yet have an FEI number if:
- Facility registration has not been submitted
- Registration is still under review
- Facility information is inconsistent
- No regulatory interaction has occurred
Completing facility registration is the first step.
Why FEI Numbers Matter for Cosmetics
FEI numbers support:
- Product listing linkage
- Inspection scheduling
- Regulatory traceability
- Compliance verification
They improve the US FDA’s ability to monitor cosmetic facilities.
Common FEI-Related Mistakes
- Assuming FEI equals registration
- Using incorrect FEI numbers
- Creating duplicate facility records
- Not verifying FEI accuracy
These mistakes can delay compliance.
Best Practices
- Register facilities promptly
- Keep facility data consistent
- Maintain FEI records centrally
- Verify FEI before submissions
- Work with an experienced US FDA Consultancy
How XPRO America Supports FEI Assignment
XPRO America operates as a trusted US FDA Consultancy providing:
- Cosmetic facility registration
- FEI verification support
- US Agent services
- Product listing coordination
- Regulatory correspondence handling
- MoCRA compliance monitoring
For professional assistance, contact support@xproamerica.com.
Compliance Insight
You do not request an FEI number—you trigger its assignment by properly registering your cosmetic facility and engaging in regulatory submissions with accurate data. FEI numbers are a byproduct of compliance, not a substitute for it.
With guidance from XPRO America, cosmetic companies can obtain FEI numbers through correct regulatory pathways and maintain full US FDA compliance.
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