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The US FDA FEI Number is a critical identifier used by the United States Food and Drug Administration to recognize, monitor, and regulate establishments involved in FDA-regulated activities. Whether your organization handles drugs, APIs, medical devices, cosmetics, or other regulated products, understanding the FDA Establishment Identifier (FEI) is essential for regulatory compliance.
XPRO America is a US FDA Consultancy providing structured and compliance-focused support for FDA establishment registration, FEI number identification, verification, and renewal services globally.
What Is a US FDA FEI Number?
An FEI number (Firm Establishment Identifier) is a unique numeric identifier assigned by the US FDA to a physical establishment. It is not a product approval, license, or marketing authorization. Instead, it is a permanent facility identifier used by the FDA for internal regulatory tracking.
Once issued, an FEI number remains permanently linked to that specific location, even if ownership, company name, or operational details change.
What Is the FEI Number for the FDA Used For?
The US FDA uses the FEI number to:
- Identify regulated establishments
- Track inspection history and outcomes
- Manage compliance records
- Link registration, listing, and inspection data
- Support enforcement and regulatory actions
The FEI number allows the FDA to maintain continuity across inspections, submissions, and regulatory correspondence.
Who Needs an FEI Number?
An FEI number is required for establishments that must register with the US FDA, including:
- Drug manufacturers and processors
- Drug repackagers and relabelers
- API and bulk drug substance facilities
- Contract manufacturing organizations
- Certain food and dietary supplement facilities
If your establishment is subject to FDA Drug Establishment Registration, an FEI number will be assigned or referenced during the process.
Where Can I Find My FDA FEI Number?
Many firms ask, “Where can I find my FDA FEI number?” The FEI number is not always visible in public databases. You can usually locate it through:
- Official FDA inspection correspondence
- Establishment Inspection Reports (EIR)
- FDA Form 483 (if issued)
- Previous FDA registration or renewal filings
- Regulatory emails or compliance letters
If records are incomplete or unclear, professional FDA Establishment Identifier (FEI) Registration Assistance can help retrieve or validate the correct FEI.
How to Search FEI Number?
A common question is “How to search FEI number?” FEI numbers are not fully searchable publicly due to confidentiality and data protection rules.
However, FEI verification can be performed through:
- Internal FDA regulatory channels
- Supplier and establishment evaluation records
- Cross-verification during FDA registration or renewal
- Historical inspection documentation
XPRO America supports firms in identifying and confirming FEI numbers using approved Firm/Supplier Evaluation Resources, ensuring accuracy before submission.
What Is a US FDA Number?
The term US FDA number can refer to multiple identifiers:
- FEI number (establishment identifier)
- Registration number
- Product listing reference
Among these, the FEI number uniquely identifies the facility, not the product. Understanding this distinction is crucial to avoid submission errors and compliance delays.
FDA Drug Establishment Registration & FEI Number
For drug-related facilities, the FEI number is a core requirement during:
- Initial FDA Drug Establishment Registration
- Annual US FDA Drug Establishment Registration Renewal
- Drug product listing submissions
- Inspection readiness and follow-up actions
Incorrect or mismatched FEI information can result in rejected registrations, delayed renewals, or regulatory scrutiny.
How to Check US FDA Registration Using FEI
While FEI numbers are not displayed openly, they are used internally by the FDA to confirm:
- Establishment registration status
- Inspection history
- Compliance standing
During renewals and regulatory submissions, the FEI number must match FDA records precisely. Verification before submission helps prevent costly corrections.
Frequently Asked Questions (FAQs) About the US FEI Portal
How do I find my FDA product code?
FDA product codes are separate from FEI numbers and relate to product classification, not facilities.
Does every facility have only one FEI number?
Each physical location receives its own FEI number. Multiple locations mean multiple FEIs.
Can an FEI number change?
No. Once assigned, the FEI number remains permanently associated with that establishment.
Is FEI required every year?
Yes. The FEI number is mandatory for annual establishment registration renewals.
Why Work With XPRO America?
XPRO America is a specialized US FDA Consultancy offering:
- FDA Establishment Identifier (FEI) Registration Assistance
- FEI number identification and validation
- FDA Drug Establishment Registration & Renewal
- Regulatory compliance support
- Accurate handling of FDA correspondence
Our structured approach ensures your FEI number is correctly aligned with US FDA records, reducing regulatory risk and ensuring uninterrupted compliance.
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