What registration and an FEI are
Section 510 of the Federal Food, Drug, and Cosmetic Act is 21 U.S.C. 360. It says "every person who owns or operates any establishment in any State engaged in the manufacture, preparation, propagation, compounding, or processing of a drug or drugs shall register with the Secretary". A foreign establishment registers before its drug is imported or offered for import into the United States (21 CFR 207.21(b)).
The FDA's Data Dashboard glossary defines the number you are looking for: "FEI is an acronym which stands for FDA Establishment Identifier. It is also known as the Firm or Facility Establishment Identifier. The FEI number is a unique identifier assigned by the FDA to identify firms associated with FDA regulated products."
Three numbers turn up on supplier paperwork. They are different things.
| Number | Who assigns it | What it identifies | Source |
|---|---|---|---|
| FEI | The FDA | The establishment. The FDA's registration site prints one on each row, next to that establishment's address. | FDA Data Dashboard glossary |
| DUNS | A private business-data company, not the FDA | The facility, for registration purposes. A unique facility identifier is part of the registration information (21 CFR 207.25(e)), and the FDA's guidance says its "preferred UFI for a drug establishment is the Data Universal Numbering System D-U-N-S (DUNS) number". | 21 CFR 207.25; the FDA's UFI guidance, 2014 |
| NDC labeler code | The FDA | The labeler of a listed drug. It is the first segment of a National Drug Code: "The labeler code is assigned by FDA." A labeler "may be a manufacturer, including a repackager or relabeler, or the entity named on the product label". | 21 CFR 207.33; the FDA's NDC Directory page |
For the lot file, the FEI is the number to capture.
What to have in hand
Start from the documents that came with the lot. This list is our practice.
- The manufacturer's name, exactly as the COA prints it.
- The manufacturing site address on the COA.
- Any FEI or DUNS printed on the COA or on the supplier's paperwork.
- The supplier's name, where the supplier is not the manufacturer.
Repacking and relabeling are registered activities as well. 21 CFR 207.21(a) sets registration of a domestic establishment "no later than 5 calendar days after beginning to manufacture, repack, relabel, or salvage a drug". Where a repackager handled the lot, we run the lookup once for each establishment and keep two entries, each labeled by its role. The guide to repackaged API covers what the COA names in that case.
The lookup, step by step
The steps use the FDA's Drug Establishments Current Registration Site, known as DECRS. The search is public.
- Copy from the COA
Work from the document. Write the manufacturer's name and site address down as printed.
- Open the search
Go to the Drug Establishments Current Registration Site. The page prints a "Data Current through" date. Note it.
- Search the firm name
The search box is labeled "Search for Firm Name". Enter the name from the COA.
- Read the row
Each result carries six columns: Firm Name, FDA Establishment Identifier, DUNS, Business Operations, Address and Expiration Date.
- Match the site
Compare the address on the row with the address on the COA. Registration is by establishment, so match on the address and not on the name alone.
- Record the row
Write down the FEI, the DUNS, the Business Operations entry and the Expiration Date exactly as shown.
- Add a second source
This step is optional. The NDC Directory's Unfinished Products tab searches by nonproprietary name, NDC code or labeler. The FDA Data Dashboard searches inspection records by firm name or FEI number.
- Save a dated capture
Save the result as a PDF or a screenshot with today's date and the "Data Current through" line in view. File it with the lot.
If the name does not come up. This is a matter of name matching. A COA can print a trade name, an abbreviation or a parent company's name. Try the name as it appears on the container label and on the supplier's paperwork. Then ask the supplier for the registered establishment name and the FEI, and search again. Note each name you tried in the file.
The four tools and what each shows
| Tool | What it shows | Good to know |
|---|---|---|
| DECRS | The FDA calls it "a publication of currently registered establishments which manufacture, prepare, propagate, compound or process drugs that are distributed in the U.S. or marketed for import to the U.S." A row gives the firm name, FEI, DUNS, business operations, address and expiration date. | Public search by firm name. "This file is updated each business day." |
| FEI Search Portal | In the portal's words, it "allows a user to look up a FDA Establishment Identifier (FEI) based on a firm name and address or validate an address of an FEI". | It opens on a sign-in page and asks for an account. We did not sign in for this guide, so this row repeats only what the sign-in page says. |
| NDC Directory | Listed drugs by National Drug Code, under three tabs: Finished Products, Unfinished Products and Compounded Products. The Unfinished Products tab searches by nonproprietary name, NDC code or labeler. | The FDA says: "Inclusion in the NDC Directory does not indicate that FDA has verified the information provided". It adds: "The NDC Directory does not contain all listed drugs." |
| FDA Data Dashboard | Inspection records, searchable by firm name or FEI number. Its glossary lists three inspection classifications: No Action Indicated (NAI), Voluntary Action Indicated (VAI) and Official Action Indicated (OAI). | "The datasets are updated weekly and only include final actions." |
Read inspection dates the way the FDA asks. Its inspections page says: "Time between surveillance inspections should not be interpreted as a measure of facility or product quality (i.e., not having been inspected in several years does not mean there should be less confidence in the facility or its products)."
What DECRS does not list. The FDA's page says: "This database does not contain establishments registered as human drug compounding outsourcing facilities." It also does not contain wholesale drug distributors and third-party logistics providers, which report licensure to the FDA each year. Those appear in the FDA's wholesale distributor and third-party logistics provider database.
What registration means, and what it does not
The regulation is direct about the limit. 21 CFR 207.77(a): "Registration of an establishment or listing of a drug does not denote approval of the establishment, the drug, or other drugs of the establishment".
So the capture records one fact: on the date you looked, the establishment was in the FDA's list of currently registered establishments. It is not a statement about any lot.
Registration does carry a consequence. 21 U.S.C. 360(h)(1): "Every establishment that is required to be registered with the Secretary under this section shall be subject to inspection pursuant to section 374 of this title."
It is renewed every year. 21 CFR 207.29(b)(1): "Subsequent reviews and updates must occur annually, during the period beginning on October 1 and ending December 31 of each calendar year." The FDA's DECRS page adds: "Establishments that send initial or annual registrations during the October 1 to December 31 period are considered registered until the end of following calendar year."
Our practice follows from the calendar. We take a fresh capture each year after the window closes, and again when a new supplier or a new manufacturing site enters the file.
What to save to the lot file
The statute's condition is that a bulk drug substance be "manufactured by an establishment that is registered under section 360 of this title" (21 U.S.C. 353a(b)(1)(A)(ii)). It does not say how a pharmacy records the check. This is what we keep.
| What to capture | Where it comes from | Why it is kept |
|---|---|---|
| Firm name as registered | The DECRS row | Ties the manufacturer named on the COA to the registration record. |
| FEI | The DECRS row, "FDA Establishment Identifier" column | The FDA's identifier for the establishment. |
| DUNS | The DECRS row | Matches paperwork that prints a DUNS. |
| Address | The DECRS row | Matches the site named on the COA. |
| Business Operations | The DECRS row | Records what the establishment registered to do. "All types of operations performed at each establishment" is registration information under 21 CFR 207.25(f). |
| Expiration Date | The DECRS row | Tells you when the next capture is due. |
| Two dates | The "Data Current through" line and the day you looked | Dates the record. |
| The capture itself | A PDF or screenshot of the result | Lets the next reader see what you saw. |
Our public tools page runs a manufacturer lookup against the FDA's registries with no account. The supplier qualification page shows the dated file a capture like this goes into.
Sources
Every source below was opened and read for this page. Last reviewed: November 11, 2026.
- 21 U.S.C. 360. Section 510 of the Federal Food, Drug, and Cosmetic Act. Read at Cornell Law School's LII.
- 21 U.S.C. 353a. Section 503A of the Federal Food, Drug, and Cosmetic Act. Read at Cornell Law School's LII.
- 21 CFR 207.21. When an establishment registers. Read at Cornell Law School's LII.
- 21 CFR 207.25. The information a registration carries. Read at Cornell Law School's LII.
- 21 CFR 207.29. The yearly review and update. Read at Cornell Law School's LII.
- 21 CFR 207.33. The National Drug Code and the labeler code. Read at Cornell Law School's LII.
- 21 CFR 207.77. What registration and listing do not denote. Read at Cornell Law School's LII.
- Drug Establishments Current Registration Site (DECRS). The FDA's page about the site. Content current as of February 5, 2026.
- Drug Establishments Current Registration Site, the search. The FDA's public search.
- FEI Search Portal. The FDA. Opens on a sign-in page; we read that page only.
- National Drug Code Directory. The FDA's page about the directory. Content current as of March 4, 2026.
- National Drug Code Directory, the search. The FDA's public search.
- FDA Data Dashboard. The FDA's public inspection and enforcement data.
- FDA Data Dashboard, glossary. Defines the FEI and the inspection classifications.
- FDA Data Dashboard, inspections. The inspections dataset and the FDA's notes on reading it.
- FDA Data Dashboard, firm and supplier evaluation resources. Search by firm name or FEI number.
- Specification of the Unique Facility Identifier (UFI) System for Drug Establishment Registration. The FDA, guidance for industry, November 2014. Nonbinding.
- Wholesale Distributor and Third-Party Logistics Providers Reporting. The FDA's public database of reported licenses.
We read documents. We do not test material.