Frequently Asked Questions (FAQs) about the US FEI Portal

The US FEI Portal allows a user to look up an FDA Establishment Identifier (FEI) based on a firm name and address or validate the address of an FEI.

1. What is an FEI?

An FDA Establishment Identifier or Firm Establishment Identifier (FEI) is an FDA system-generated number used to identify a firm. The FDA systems interact, occasionally creating multiple records (FEIs) for one firm. Upon evaluation, these numbers are merged into one surviving FEI, which is used to identify the firm. The remaining FEIs become children of the surviving FEI and are not used to identify the firm.

2. What is the FEI Portal for?

To facilitate the processing of actions within various parts of the FDA, information submitted should be as accurate and complete as possible, for example, in the importation of FDA-regulated products. The FEI portal was developed to assist firms in identifying FEIs associated with a specific address. Having the correct and current FEI for a firm ensures database look-ups or inquiries can be conducted as quickly as possible.

3. How do I use the FEI Portal?

After logging into the portal with an account on the account login, the search allows you to search for an FEI or name and physical address of a firm. When searching for an FEI, the firm name and physical address search will be grayed out and not be possible to use, and vice versa. If there is a result returned from the search it will display the firm’s FEI, name, physical address, and mailing address.

4. Why can’t I find an FEI, name, or address I know exists?

Not all FEIs are searchable within this portal. FEIs may be associated with information not considered releasable. For example, when an FEI, firm name, or address has personally identifiable information associated with it, or a law or regulation says it can’t be released.

It is also possible that due to internal FDA rules and practices, an FEI may have changed even though the firm name and address have stayed the same. If this is the case, searching for the firm using the name and address information should return the current FEI.

5. What do I do if I can’t find the FEI, name, or address I’m looking for?

An FEI might not be found for several reasons.

• The FEI has personally identifiable information or a law or regulation says the FEI can’t be released.
• The firm at a particular address has not yet been assigned an FEI.
• A firm has changed names or address, making the search for the FEI more difficult.

If an FEI is not returned from the search engine, several other resources might be used:

• Drug Establishments Current Registration Site;
• Device Registration & Listing;
• Blood Establishment Registration and Listing; and
• Human Cell and Tissue Establishment Registration.

6. How can I request an FEI?

If you can't find an FEI using the FEI Portal for your firm or the firm you are representing, you can request one by contacting feiportal@fda.hhs.gov and providing the following information:

• The legal name of the firm being registered;
• Whether you are representing the firm as an Agent (third party);
• Any alternate firm names, including those used for "doing business as" purposes;
• The physical address of the firm being registered;
• The designated mailing address for the firm being registered;
• The name and contact information of the designated contact person at the facility being registered;
• A comprehensive list of activities conducted at this specific location (e.g., drug manufacturing, or food packaging);
• Any registration numbers associated with other FDA Centers (if applicable);
• Any former names the firm was known by; and
• Any previous addresses linked to the firm.

7. Why does selecting certain countries on the search screen result in a US address being returned?

Although the search screen country pulldown has such countries as American Samoa, Guam, the Northern Mariana Islands, Puerto Rico, and the US Virgin Islands, the FEI records have the addresses of those locations in the format used by the US Postal Service. Searching for those countries will still return a result but the address information displayed will be in the US Postal Service format.

8. What do I do if the FEI, firm name, or address I’m looking for is incorrect or shouldn’t be displayed?

Please contact feiportal@fda.hhs.gov and provide the FEI, firm name, or address that may be incorrect. If a potential discrepancy is identified, we will review and evaluate the information. Some identified discrepancies may not need to be changed if the information meets the FDA’s use of it. For example, an address of an FEI may be at a different entrance of a firm, but the firm prefers a different entrance. The FDA may keep the original entrance as the address based on information obtained during an inspection.

9. What do I do if I get the search limit exceeded message after trying to perform a search?

You can perform up to 50 searches in an hour. Once you reach the limit, please wait an hour, then log back in to continue searching.

If you need any assistance or have any questions, please contact us via service@cirs-group.com.

Further Information

FEI Portal Frequently Asked Questions (FAQ)

US FDA Issued Draft Guidance on Registration and Listing of Cosmetic Product Facilities and Products