The US FDA FEI Number is a foundational regulatory identifier used by the United States Food and Drug Administration to identify, track, and regulate establishments involved in FDA-regulated activities. For companies working with drugs and cosmetics, correct understanding and use of the FDA Establishment Identifier (FEI) is essential to maintain compliance and avoid registration or renewal delays.
XPRO America operates as a US FDA Consultancy, supporting global establishments with FEI identification, validation, and FDA establishment registration services.
What Is the FDA Establishment Identifier (FEI)?
An FEI number (Firm Establishment Identifier) is a unique, permanent numeric identifier assigned by the US FDA to a specific physical facility. The FEI number allows the FDA to recognize an establishment consistently across all regulatory systems.
Important characteristics of an FEI number include:
- Issued only by the US FDA
- Assigned at the establishment level, not company level
- Permanently associated with a physical location
- Used throughout inspections, registrations, and compliance actions
The FEI number does not indicate product approval, product authorization, or certification.
What Is the FEI Number for the FDA?
From a regulatory standpoint, the FEI number serves as the primary facility reference within FDA databases. It connects multiple regulatory elements, including:
- Establishment registration and annual renewal records
- Inspection history and compliance outcomes
- Enforcement actions and warning correspondence
- Internal FDA tracking and evaluation systems
Once assigned, the FEI number remains active even if the establishment’s ownership, company name, or operational structure changes.
Who Needs an FEI Number?
An FEI number is required for establishments that are subject to US FDA registration obligations. This typically includes:
- Drug manufacturing and processing facilities
- Active pharmaceutical ingredient (API) manufacturers
- Drug repackagers and relabelers
- Cosmetic manufacturing establishments
- Contract manufacturing and testing facilities
If your operations fall under FDA Drug Establishment Registration, the FEI number becomes mandatory for initial registration and for every annual renewal.
Where Can I Find My FDA FEI Number?
One of the most common compliance questions is, “Where can I find my FDA FEI number?” FEI numbers are not always visible in public databases, but they are usually available through:
- Official FDA inspection correspondence
- Establishment Inspection Reports (EIR)
- FDA Form 483 documentation, if issued
- Previous FDA registration or renewal filings
- Direct regulatory emails from the FDA
If records are incomplete or inconsistent, professional FDA Establishment Identifier (FEI) Registration Assistance helps confirm and validate the correct FEI before submission.
How to Search FEI Number
Many firms ask, “How to search FEI number?” FEI numbers are not publicly searchable due to regulatory confidentiality and data protection requirements.
However, FEI identification and verification can be completed through:
- Historical FDA registration records
- Inspection documentation and compliance history
- Firm/Supplier Evaluation Resources
- Internal FDA system verification during registration or renewal
XPRO America assists establishments in validating FEI details accurately, reducing the risk of submission errors or regulatory delays.
What Is a US FDA Number?
The term US FDA number is often used broadly and may refer to different identifiers, such as:
- FEI number (establishment identifier)
- Establishment registration number
- Product listing reference
Among these, the FEI number specifically identifies the facility, not the product. Confusing these identifiers is a common cause of registration rejection and renewal delays.
FDA Drug Establishment Registration & FEI Number
For drug-related establishments, the FEI number plays a central role in:
- Initial FDA Drug Establishment Registration
- Annual US FDA Drug Establishment Registration Renewal
- Drug product listing submissions
- Inspection preparation and post-inspection responses
Any mismatch between FEI records and registration data can trigger FDA queries, delayed renewals, or corrective actions.
How to Check US FDA Registration Status
Although FEI numbers are not openly displayed, they are used internally by the FDA to verify:
- Establishment registration validity
- Inspection history and compliance standing
- Regulatory status during renewals and updates
Verifying FEI accuracy before filing ensures alignment with FDA records and minimizes regulatory risk.
Why Choose 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 support
- Compliance-focused documentation review
- Consultant-led handling of FDA correspondence
Our structured approach ensures your FEI number is accurate, consistent, and fully aligned with US FDA regulatory systems.
For professional US FDA FEI Number & establishment registration assistance, email support@xproamerica.com
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