The US FDA FEI Number is a critical regulatory identifier used by the United States Food and Drug Administration to track, monitor, and regulate establishments involved in FDA-regulated activities. Any organization engaged in drug manufacturing, processing, repackaging, relabeling, or related operations must clearly understand the role of the FDA Establishment Identifier (FEI) to maintain uninterrupted compliance.
XPRO America is a US FDA Consultancy providing expert, consultant-led guidance for FEI identification, validation, and FDA establishment registration support for companies operating globally.
Understanding the FDA Establishment Identifier (FEI)
An FEI number (Firm Establishment Identifier) is a unique numeric identifier assigned by the US FDA to a physical establishment. It allows the FDA to recognize a specific facility across all regulatory systems.
Key characteristics of an FEI number include:
- Assigned only by the US FDA
- Permanently linked to a facility location
- Used throughout inspections, registrations, and compliance actions
It does not represent product approval or market authorization.
What Is the FEI Number for the FDA?
From the FDA’s regulatory perspective, the FEI number serves as a central establishment reference. It connects:
- FDA establishment registration records
- Inspection history and outcomes
- Compliance status and enforcement actions
- Official regulatory correspondence
Once issued, the FEI number remains active in FDA systems even if company ownership or naming conventions change.
Who Needs an FEI Number?
An FEI number is required for any establishment subject to US FDA registration requirements, including:
- Drug manufacturers and processors
- API and bulk drug substance facilities
- Drug repackagers and relabelers
- Contract manufacturing and testing organizations
If your activities fall under FDA Drug Establishment Registration, an FEI number is mandatory for both initial registration and annual renewals.
Where Can I Find My FDA FEI Number?
Many firms ask, “Where can I find my FDA FEI number?” FEI numbers are not always visible in public databases, but they can typically be found in:
- FDA inspection correspondence
- Establishment Inspection Reports (EIR)
- FDA Form 483 documentation
- Previous FDA registration or renewal filings
- Official FDA emails or compliance letters
If documentation is unavailable or unclear, professional FDA Establishment Identifier (FEI) Registration Assistance helps confirm the correct identifier before submission.
How to Search FEI Number
A frequent question is “How to search FEI number?” FEI numbers are not publicly searchable due to regulatory confidentiality policies. However, FEI identification and validation can be completed through:
- Historical FDA registration data
- Inspection documentation
- Firm/Supplier Evaluation Resources
- Internal FDA system verification during registration or renewal
XPRO America supports establishments in validating FEI numbers accurately to prevent filing errors.
What Is a US FDA Number?
The term US FDA number is often used broadly and may refer to:
- FEI number (establishment identifier)
- Registration number
- Product listing reference
Among these, the FEI number specifically identifies the facility, not the product. Understanding this distinction is essential for accurate regulatory submissions.
FDA Drug Establishment Registration & FEI Number
For drug-related facilities, the FEI number is required during:
- Initial FDA Drug Establishment Registration
- Annual US FDA Drug Establishment Registration Renewal
- Drug product listing updates
- Inspection readiness and post-inspection responses
Incorrect FEI linkage can lead to registration delays, rejections, or compliance inquiries.
How to Check US FDA Registration Status
Although FEI numbers are not openly displayed, they are used internally by the FDA to confirm:
- Establishment registration validity
- Inspection history
- Regulatory compliance status
Verifying FEI accuracy before submissions ensures alignment with FDA records and reduces regulatory risk.
Why Choose XPRO America?
XPRO America is a professional US FDA Consultancy offering:
- FDA Establishment Identifier (FEI) Registration Assistance
- FEI number identification and validation
- FDA Drug Establishment Registration & Renewal
- Compliance-focused documentation support
- Consultant-led handling of FDA correspondence
Our expert-driven approach ensures your FEI number is accurate, consistent, and fully aligned with US FDA regulatory systems.
Contact support@xproamerica.com
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