What Is FDA Establishment Identifier (FEI)?
An FDA Establishment Identifier (FEI) is a unique, 10-digit number assigned by the U.S. Food and DrugAdministration (FDA) to facilities that manufacture, test, pack, or distribute FDA-regulated products,including pharmaceuticals.
The FEI plays a critical role in:
Tracking inspections and compliance history
Facility registration and product submissions
Monitoring operational changes or site updates
Whether you're submitting a drug application or preparing for an inspection, having an accurate FEI ensuresthe FDA can easily identify your site in its systems.
Why Is FDA Establishment Identifier (FEI) Important?
FDA Establishment Identifier (FEI)
For pharmaceutical companies, the FEI isn’t just a formality — it’s foundational to regulatory compliance.
Without a valid FEI:
- Your facility cannot complete key FDA submissions
- Inspections may be delayed or misdirected
- You risk non-compliance flags during FDA audits
Getting your FEI right the first time avoids regulatory setbacks and streamlines your broader compliance journey.
Process Flow for FDA Establishment Identifier (FEI)
Information Collection
We gather essential details about your facility (location, type of operation, industry classification, etc.).
Data Verification
Our team checks all information for completeness and consistency to prevent delays.
FEI Submission
We submit your FEI request directly to the appropriate FDA office.
Follow-Up & Confirmation
We monitor progress and provide you with the official FEI once assigned.
Post-FEI Support
If your FEI is required for other filings (e.g., SPL, DMF, NDC), we can assist further.
How Can We Help in FDA Establishment Identifier (FEI)?
Expert FEI Request Services : We handle the FEI request process for FDA-regulated pharma facilities of all sizes.
Seamless Process : A smooth, guided application experience — with no additional FDA charges involved.
Seamless Process: We assist you through every step, from gathering information to final submission and confirmation.
Who Needs a FDA Establishment Identifier (FEI)?
Any non-U.S. company involved in drug manufacturing, testing, or handling needs a U.S. Agent.
Regulatory Requirements for FDA Establishment Identifier (FEI)
Documents
To process your FEI request accurately and efficiently, you’ll need to provide the following:
- Company Profile Document
– Basic information about the company, including ownership and business activities. - Facility Address Proof
– Utility bill, lease agreement, or business registration that confirms the physical address. - Valid Business Registration Certificate
– Government-issued documentation validating your company’s legal status. - Letter of Authorization (if applicable)
– Required if Cliniexperts is submitting the request on your behalf. We’ll provide the format. - Organizational Structure (optional)
– Especially helpful for large companies with multiple sites or divisions.
Timeline
- The typical timeline for receiving an FDA Establishment Identifier is:
- Standard Processing Time: 5–10 business days
- Expedited Requests: In some cases, quicker processing may be possible depending on FDA responsiveness and request completeness.
- We keep you updated throughout and follow up with the FDA if needed.
Fees
- U.S. Food and Drug Administration (FDA)
Validity
- The FEI number does not expire.
- However, the information linked to your FEI (like facility address or business activity) must be kept current and accurate.
If your operation changes (e.g., you add a new manufacturing site or change product category), the FDA may reassign or update your FEI accordingly.
We offer ongoing compliance support to help you maintain updated records.
Frequently Asked Questions(FAQs)
What is an FDA Establishment Identifier (FEI)?
An FEI is a unique 10-digit number assigned by the FDA to identify and track facilities involved in manufacturing, testing, packing, or distributing FDA-regulated products such as drugs, devices, and biologics.
Is the FEI the same as a registration number or DUNS number?
No. An FEI is assigned by the FDA specifically for inspection and regulatory tracking. A DUNS number is issued by Dun & Bradstreet for business identification and is often required during drug listing or GDUFA submissions. They serve different regulatory purposes.
How long does it take to receive an FEI?
Generally, the FDA processes FEI requests within 5–10 business days. However, timelines may vary depending on request volume, completeness of submitted data, and responsiveness of the facility.
Does the FEI need to be renewed?
No, an FEI number does not expire. However, it’s important to keep your facility’s information up to date with the FDA. Changes in facility address, ownership, or business activity may require updates to your FEI profile.
Is there a government fee to obtain an FEI?
No. The FDA does not charge any fee for assigning an FEI. However, if you’re using a third-party consultant (like Cliniexperts), a service fee may apply for handling the request and ensuring compliance.
