An FDA registration lookup is a search of FDA's public establishment registries to confirm that a facility has registered with the agency, by firm name, FEI number or registration number. Drug establishments are listed on the Drug Establishments Current Registration Site (DECRS), device establishments in the Registration and Listing database, and food facility registrations are not public at all.
This guide uses FDA's drug registration file of November 6, 2026, joined to FDA inspection classifications, to show what a registration hit tells you and what it leaves out.
- FDA's drug registration file of November 6, 2026 lists 9,901 establishments by FEI number, 5,309 of them in the United States, 1,117 in China and 1,036 in India.
- 57.2% of those drug establishments still show an expiry of December 31, 2026, so they had not yet renewed in the October 1 to December 31 window.
- Under 21 CFR 207.77 and 807.39, registration does not denote FDA approval of the establishment or its products, and claiming otherwise is misbranding.
- Food facility registration lists are exempt from FOIA disclosure under 21 CFR 1.243, and FDA issues a registration number, never a certificate.
- Of 1,850 registered drug establishments with a final classification for an inspection ending between January 2, 2025 and October 14, 2026, 221 had at least one Official Action Indicated (OAI) outcome.
How do you check if a company is FDA registered?
To check if a company is FDA registered, first identify what the facility makes, then search the registry for that product type: DECRS for drugs and active pharmaceutical ingredients, the device Registration and Listing database for medical devices. Food facilities cannot be looked up publicly; ask the supplier for its registration confirmation.
| Product type | Registry | Public? | Search by | Renewal window |
|---|---|---|---|---|
| Human and animal drugs, APIs | Drug Establishments Current Registration Site (21 CFR Part 207) | Yes, search tool plus a download refreshed each business day | Firm name, FEI number, DUNS number | October 1 to December 31, every year |
| Medical devices | Establishment Registration and Device Listing (21 CFR Part 807) | Yes, updated weekly, generally by Monday evening | Establishment or owner/operator name, registration or FEI number, product code, device name | October 1 to December 31, every year |
| Food and animal food | Food Facility Registration (21 CFR 1.225) | No | Not searchable | October 1 to December 31 of even-numbered years |
One company usually means several registrations. Each registered establishment carries its own FEI number, so a supplier with three facilities appears three times. Match the street address, not the company name, before you treat a hit as the facility you buy from. Our guide to the FEI number explains how FDA assigns it and why it is the safest search key.
How do you look up a drug establishment registration?
A drug establishment registration lookup runs on DECRS, FDA's list of currently registered establishments that manufacture, prepare, propagate, compound or process drugs distributed in or imported into the United States. Search the firm name or FEI, or download the file, which FDA refreshes each business day.
- Open the DECRS search and enter the firm name or FEI number.
- Confirm the address against your supplier file. Names repeat across group companies.
- Read the operations field: manufacture, API manufacture, analysis, pack, label, repack, relabel, sterilize and others. A contract lab registers for analysis only.
- Read the expiration date. An entry that expires December 31, 2026 has not been renewed for 2027 yet.
- Note the FEI number for the inspection search in the next step.
The download holds 14 columns: FEI number, DUNS number, firm name, address, expiration date, operations, establishment contact, US agent, registrant name and DUNS, registrant contact and an exclusion flag. In the November 6, 2026 file, manufacture appears for 5,378 FEIs, analysis for 3,245 and API manufacture for 2,401.
DECRS has two gaps that matter for supplier checks. It does not list human drug compounding outsourcing facilities registered only as such, which have their own FDA list (our 503B outsourcing facility guide covers it). It also drops an establishment once FDA inactivates the registration for a compliance case or other enforcement action, or once the registration expires. FDA also publishes a separate "excluded" file, 23 rows on November 6, 2026, without defining what places a firm on it.
How do you look up a medical device establishment registration?
A medical device registration lookup runs on FDA's Establishment Registration and Device Listing database, which lists registered device establishments and the devices each one has listed. The search form takes establishment or trade name, owner/operator name or number, registration or FEI number, product code, device classification name, establishment type and country.
Device records show two parties: the establishment that does the work and the owner/operator that registers it. A contract manufacturer and the brand that sells the device can both appear, with different establishment types. FDA notes a delay between a firm's upload and the public database, and updates are generally completed weekly by Monday evening, so a registration filed this week may not show until next week.
Under 21 CFR 807.22, a new device establishment registers within 30 days of starting operations, and every establishment re-registers each year between October 1 and December 31.
Can you look up a food facility registration number?
No. A food facility registration number cannot be looked up publicly. Under 21 CFR 1.243, FDA's list of registered food facilities and the registration documents are exempt from disclosure under the Freedom of Information Act, and so is any information that would identify a specific registered facility.
FDA issues a registration number to a registered food facility. It does not issue a certificate of registration, and it does not recognize certificates sold by private businesses. If a buyer needs proof, the facility can share a copy of its registration confirmation. Food facilities renew every other year, between October 1 and December 31 of even-numbered years, which makes the current 2026 window a renewal period. Under 21 CFR 1.241, FDA treats a registration that is not renewed as expired.
Does FDA registration mean FDA approval?
FDA registration does not mean FDA approval. 21 CFR 207.77 states that registering a drug establishment or listing a drug does not denote approval of the establishment or the drug, and that any representation creating that impression is misleading and constitutes misbranding. 21 CFR 807.39 says the same for device establishments.
| Term | What it means | Who decides |
|---|---|---|
| Registered | The establishment told FDA it exists, where it is and what it does | The firm, by filing |
| Listed | The firm told FDA which products it makes there | The firm, by filing |
| Cleared | FDA found a device substantially equivalent through a 510(k) | FDA review |
| Approved | FDA approved a drug application or a device PMA | FDA review |
| Inspected | FDA visited and classified the outcome NAI, VAI or OAI | FDA investigator and center |
The text of 21 CFR 207.77 also covers the NDC: appearing in FDA's drug database or carrying an NDC confers no approval either. Wording such as "FDA registered facility" on a supplier's website is a statement of filing status.
How many registered drug facilities have an OAI?
Of the 1,850 drug establishments that were on FDA's registration list on November 6, 2026 and had a final classification for an inspection ending between January 2, 2025 and October 14, 2026, 221 (11.9%) had at least one OAI outcome. Another 1,161 (62.8%) had a VAI as their worst outcome and 468 (25.3%) were NAI only.
Read the other way, 317 drug FEIs received an OAI in that period and 221 of them, 69.7%, were still registered on November 6, 2026. An OAI means FDA found objectionable conditions and plans regulatory or administrative action; it does not cancel a registration by itself. The rest of the 3,193 inspected drug FEIs were not on the list: they include pharmacies and outsourcing facilities that DECRS leaves out, and registrations that lapsed or were inactivated. Our guide to NAI, VAI and OAI classifications explains what follows each outcome.
The method: we matched FEI numbers in the DECRS download of November 6, 2026 against FDA Data Dashboard inspection classifications for the product type Drugs, then kept each facility's worst classification in the period.
If one of your suppliers is among the 221, its registration entry will look the same as everyone else's; the OAI, the Form 483 behind it and the investigator who wrote it sit in the inspection record.
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From a registration hit to the facility's inspection record
The FEI number on a registration is the key to the inspection record. Run it through the FDA Data Dashboard for classifications, the warning letter list for enforcement, and the Atlas FDA-inspected sites directory for Form 483s, observations and investigators. Two registered facilities show why.
Zhejiang Huahai Pharmaceutical Co., Ltd. in Linhai, China (FEI 3003999190) is on the November 6, 2026 drug registration list for API manufacture and manufacture, with an expiry of December 31, 2027, so it has already renewed for next year. FDA classified two of its inspections OAI, one ending January 24, 2025 and one ending April 24, 2026, and CDER issued it a CGMP warning letter dated June 6, 2025. The Atlas record for the Linhai facility (release of August 15, 2026) holds 12 FDA inspections, 6 of which produced a Form 483; the registration entry shows none of these events.
Baxter Healthcare Corporation in Cleveland, Mississippi (FEI 1019003) is registered through December 31, 2027 for analysis, labeling, manufacture, packing and sterilization. FDA classified its inspection ending September 29, 2025 OAI. The Atlas record for the Cleveland facility shows 16 inspections and 5 Form 483s; the September 2025 form lists five observations, under 211.160(b), 211.192, 211.58, 211.67(a) and 211.68(b), all cited by investigator Camerson E Moore, whose profile holds 185 inspections across 168 sites. This is a different facility from the one in our Baxter warning letter 2026 analysis, which covers Round Lake, Illinois.
For the enforcement step, our FDA warning letter database guide shows how to trace a letter back to its 483, and our note on import alerts covers the list that can stop a registered foreign facility's shipments at the border.
When must FDA registration be renewed?
FDA registration for drug and device establishments must be renewed every year between October 1 and December 31, and food facility registration every other year in the same window of even-numbered years. A domestic drug establishment registers no later than 5 calendar days after it starts operations, and a foreign one before its drug is imported or offered for import (21 CFR 207.21).
Drug registrants must also update FDA within 30 calendar days of closing or selling an establishment, or changing its name or address (21 CFR 207.29). For a supplier file, that sets a simple rule: re-check DECRS in January. In the November 6, 2026 file, 5,659 drug FEIs still expire on December 31, 2026; any of your suppliers among them should show a 2027 date by early January.
If you qualify suppliers on registration alone, our supplier qualification guide sets out the checks FDA expects beyond it.
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Frequently asked questions
An FEI number is the FDA Establishment Identifier that FDA uses to track a facility across inspections, warning letters and imports. A registration number is assigned when the facility registers. For drug establishments, DECRS lists the FEI and DUNS numbers. For device establishments, the search form accepts either number in one field, labeled Registration or FEI Number.
Written by
Bhavish Agarwal
Founder, Atlas
Bhavish Agarwal is the founder of Atlas and previously worked at Google and Microsoft. He has spent the past several years building regulatory data infrastructure for the pharmaceutical industry.
