Establishment name as FDA lists it, FEI, address and country, registered operations (for example API manufacture, analysis, labeling), the registration expiry date, the registrant firm and the U.S. agent's firm name, plus the date of the DECRS file that was checked.
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FDA drug establishment registration lookup.
Find whether a drug manufacturer, API or excipient maker holds a current FDA establishment registration: the FEI, address, operations, expiry date and U.S. agent, read from FDA's daily DECRS file and dated on every result.
Establishment registration only. This does not verify device clearance, approval, authorization, quality or import admissibility. Verify in FDA's official database.
Quick answer
FDA publishes its drug establishment registrations as a daily file — and this lookup reads it.
Drug manufacturers, API and excipient makers, packagers, labelers and testing laboratories that supply the U.S. market register their establishments with FDA (DRLS/eDRLS). FDA publishes the current registrations on its Drug Establishments Current Registration Site (DECRS) as a downloadable file, refreshed daily, with each establishment's FEI, address, operations, registrant and U.S. agent firm. There is no API, so this lookup keeps a dated copy of that file and searches it by FEI or by firm name whenever the device registry returns nothing. The file's date is shown on every result.
What the result shows — and what it does not
The FDA file also carries contact names, e-mail addresses and phone numbers for each establishment. Those contact details are not displayed by this lookup and are not kept in its copy of the file.
A drug establishment registration is not a device establishment registration, not a drug approval and not a statement about product quality or import admissibility. It says the site is registered with FDA for the listed operations, as of the file date.
How to check a drug supplier's registration
- Enter the supplier's legal name, or the FEI if the supplier gave you one; leading zeros and words like “FEI number” around the name are ignored.
- If the device registry returns nothing, the result says whether the name appears in FDA's DECRS file, with the FEI and the file date.
- Compare the establishment name, address and operations with the supplier's documents: a trading company may quote the FEI of a separate manufacturer.
- Confirm the current record on FDA's DECRS site and ask the supplier for product-specific evidence (approved application, monograph, GMP status) — registration alone does not establish any of those.
Registrations expire on December 31 and are renewed each autumn. An establishment missing from the file can be in the middle of a renewal, registered under another legal name, or simply not registered: a no-match is a reason to ask, not a finding.
Questions
Can I look up an FDA drug establishment registration?
Yes. FDA publishes its current drug establishment registrations (DECRS) as a daily file with each establishment's FEI, address, operations and expiry date. This lookup searches a dated copy of that file by FEI or firm name after a device-registry miss, and links to FDA's official DECRS site for confirmation.
What is DRLS and how is it different from DECRS?
DRLS (Drug Registration and Listing System) is where firms register establishments and list products with FDA. DECRS (Drug Establishments Current Registration Site) is FDA's public view of the current registrations that came out of that system. This lookup reads the public DECRS file.
Does a drug establishment registration mean the product is FDA approved?
No. Registration means the site reported itself to FDA for the listed operations. Approval, marketing authorization, GMP inspection status and import admissibility are separate and product-specific.
Why does my supplier not appear in the file?
Registrations expire on December 31 and are renewed each autumn, so a firm can be mid-renewal; it can be registered under a different legal name or through a parent; or it may not be registered. Treat a no-match as a question for the supplier, and confirm on FDA's official site.
Does the lookup show the establishment's contact details?
No. The FDA file includes contact names, e-mails and phone numbers; this lookup does not display them and does not keep them in its copy.