FDA Drug Establishments - daily new, renewed, changed and removed firms

Every firm registered with the US FDA to make, test, pack or label human drugs - about 10,500 establishments worldwide (API makers, finished-dose plants, contract labs, packagers, repackagers, PET drug sites) - as clean FDA establishment registration data rows keyed by FEI and DUNS.

The FDA publishes only today's list. It does not tell you who joined, who renewed, what changed or who disappeared. This Actor keeps that history for you: schedule it once a day in delta mode and get exactly the changes, including the removals (firms that dropped off the registry), which the FDA does not keep anywhere.

Use cases: what can you do with FDA establishment registration data?

1. Supplier qualification and CMO / CDMO due diligence - QA, procurement and sourcing teams. Before you approve a contract manufacturer or an API source, you need proof that it is registered, for which operations and until when. Run snapshot with countries set to the supplier's country and look the firm up by fei_number or duns_number. Check operations (for example API MANUFACTURE vs MANUFACTURE), expiration_date and the flags expiration_past and agent_missing_foreign. You get a dated qualification record: source_updated_at shows which FDA file it came from.

2. Alerts when a supplier drops off the registry - supply-chain risk and vendor management. The FDA keeps no history, so a lapsed or withdrawn registration just vanishes. Schedule delta once a day with the countries you source from and filter the dataset on change_type = removed; last_seen_at is the last run that still saw the firm. You get an early warning for a supplier that is no longer registered, before a shipment or an audit finds out.

3. Monitor new API manufacturing sites in India or China - market intelligence and sourcing. Use delta with countries: ["IND","CHN"] and operations: ["API MANUFACTURE"], then read the new rows: firm_name, address_raw, agent_name, registrant_name. You get a running list of new Asian API entrants into the US supply chain (recipe below).

4. Regulatory intelligence and competitor radar - regulatory affairs, strategy and analyst teams. Follow how a set of firms changes: in delta mode, rows with change_type = changed list changed_fields (for example operations, address_raw, agent_name, registrant_duns) and previous_values with the old values. You see that a competitor added STERILIZE or moved to a new site without reading the whole list every month.

5. Lead generation for US Agent and registration services - regulatory consultancies and US-agent providers. Foreign establishments need a US agent and a yearly renewal. Pick new and renewed rows with countries outside the US, and use agent_name, agent_duns and the flag agent_missing_foreign to find firms with no US agent listed, or expiration_date to time your outreach. You get a prospect list of companies (contacts and personal data are never output), refreshed daily.

6. Enrich a supplier master by FEI or DUNS - data and master-data teams. Join your vendor table to the registry on duns_number (always 9 digits) or on fei_number + duns_number, which is the unique key. fei_zero_padded and shared_fei tell you where an ID needed repair or is shared by several rows. You add registration status, operations, country and agent to every vendor, and a stable key to join with inspection, import-alert or EU GMP data.

7. Track the yearly renewal campaign (October to December) - compliance and account managers. Most registrations expire on 31 December and are renewed in the last quarter. Keep includeRenewals: true and read the renewed rows (previous_values.expiration_date holds the old date) to see who has renewed; in a snapshot, firms still showing the old expiration_date have not. Or switch includeRenewals off to receive only real changes.

Recipe 1: daily monitor of API manufacturers in India and China

Schedule once a day. The first run returns the full list in scope as baseline; later runs return only new, renewed, changed and removed firms.

{
  "mode": "delta",
  "countries": ["IND", "CHN"],
  "operations": ["API MANUFACTURE"],
  "includeExcluded": false,
  "includeRenewals": true,
  "maxItems": 0
}

Recipe 2: supplier shortlist for contract manufacturers in Spain, Italy and Germany

One full snapshot of firms that manufacture or analyse, ready to join with your vendor list.

{
  "mode": "snapshot",
  "countries": ["ESP", "ITA", "DEU"],
  "operations": ["MANUFACTURE", "ANALYSIS"],
  "includeExcluded": false,
  "maxItems": 0
}

How to run it

1. Fastest way to try: click Start with the pre-filled input (snapshot, Spain, 100 rows).
2. Daily monitoring: set mode to delta, add filters if you want (countries, operations) and schedule it once a day (see the recipes above). The first run returns the full list as baseline; every later run returns only changes, and finishes in seconds with no per-row charge when the FDA file has not changed (the small Actor start fee still applies).

Example output

{
  "fei_number": "1000242648",
  "fei_raw": "1000242648",
  "duns_number": "512780529",
  "firm_name": "Example Pharma Ltd",
  "address_raw": "Plot 4, Industrial Area, Hyderabad, Telangana 500001, India (IND)",
  "country_iso3": "IND",
  "operations": ["API MANUFACTURE", "ANALYSIS"],
  "operations_raw": "ANALYSIS; API MANUFACTURE",
  "expiration_date": "2027-12-31",
  "registrant_name": "Example Pharma Ltd",
  "registrant_duns": "512780529",
  "agent_duns": "116937572",
  "agent_name": "Example US Agent Inc.",
  "exclusion_flag": "N",
  "is_excluded": false,
  "source": "fda-decrs",
  "source_file": "drls_reg",
  "source_url": "https://www.accessdata.fda.gov/cder/drls_reg.zip",
  "source_updated_at": "2026-10-09T03:00:50Z",
  "first_seen_at": "2026-10-12T09:00:04Z",
  "last_seen_at": "2026-10-13T09:00:03Z",
  "detected_at": "2026-10-13T09:00:03Z",
  "change_type": "renewed",
  "changed_fields": ["expiration_date"],
  "previous_values": { "expiration_date": "2026-12-31" },
  "quality_flags": []
}

FDA Drug Establishments Actor input parameters

All parameters are optional. With the pre-filled input the Actor returns 100 Spanish establishments in snapshot mode.

Parameter	Type	Default	Description
mode	string	delta when empty (pre-filled: snapshot)	snapshot, delta or preloaded; see the modes table below.
countries	array of ISO3 codes	empty = all countries (pre-filled: ["ESP"])	Keep only establishments in these countries, read from the address (for example ESP, IND, CHN). You can type any other 3-letter code.
operations	array of strings	empty = all	Keep establishments that perform at least one of these operations (exact match on the normalised name), for example API MANUFACTURE.
includeExcluded	boolean	false	Also load the FDA list of establishments excluded from the registry (23 firms, flag E). They have no operations or expiry date.
includeRenewals	boolean	true	Delta mode only. Switch off to skip renewals: they are neither returned nor billed, and your stored state still moves forward.
maxItems	integer (min 0)	0 or empty = no limit (pre-filled: 100)	Stop after this many rows. Rows not delivered stay pending and arrive in your next delta run.
stateKey	string	empty	Name of your delta stream. Runs with the same key (or the same filters, if empty) are compared with each other.

Pre-filled input (the fastest way to try the FDA Drug Establishments Actor):

{"mode": "snapshot", "countries": ["ESP"], "maxItems": 100}

FDA establishment data modes: delta, snapshot and preloaded

Mode	What you get	Billed as
delta (default)	Only new, renewed, changed and removed establishments since your last run. First run: the full list as baseline. Source unchanged: 0 rows, no per-row charge.	establishment-change (establishment for the baseline rows)
snapshot	The full list in scope on every run, each row tagged new, renewed, changed, unchanged (or baseline on the first run), plus removals.	establishment
preloaded	The latest full list already prepared by Rastriq, served instantly and at a lower price per row; no change tracking. At launch, if that snapshot is not published yet, the run falls back to snapshot (live) mode and is billed as establishment.	establishment-preloaded

Filters only decide which rows you receive. The Actor always compares the complete list, so a removal is never missed or invented because of a filter. Each combination of filters (or each stateKey) keeps its own change history.

Change types

change_type	Meaning
new	Establishment appeared since the previous run.
renewed	Only the expiry date changed, and it moved forward - the yearly registration renewal.
changed	Any other field changed (name, address, operations, agent, registrant, exclusion, or an expiry date that moved for another reason). changed_fields and previous_values tell you what and from what.
removed	Establishment is no longer in the FDA list. last_seen_at is the last run that saw it.
unchanged	Same as before (snapshot mode only).
baseline	First run for this filter set / stateKey: starting point, not a real change.

Expect heavy renewed traffic between October and December, when most registrations are renewed for the next year. In delta mode you can switch Include renewals off: renewals are then neither returned nor billed (your state still advances, so they do not come back later).

Truncated first run: if your first run stops early (maxItems or a spending limit), no state is saved and the next run starts the baseline again, so you are never billed change prices for what is really baseline data.

FDA drug establishment output fields

Field	Description
fei_number	FDA Establishment Identifier, 10 digits (older 7-digit IDs are zero-padded). null for about 2% of firms that have none.
fei_raw	FEI exactly as published.
duns_number	D-U-N-S number of the establishment (9 digits).
firm_name	Name under which the establishment is registered. In a few cases it is a sole trader (an individual) and so may be a person's name; filter on quality_flags and your own rules if that matters to you.
address_raw	Address exactly as published, including the country.
country_iso3	ISO 3166 alpha-3 country code read from the address (e.g. ESP, IND).
operations	Normalised, sorted list: API MANUFACTURE, MANUFACTURE, ANALYSIS, PACK, REPACK, LABEL, RELABEL, STERILIZE, TRANSFILL...
operations_raw	Operations as published.
expiration_date	Registration expiry, ISO date.
registrant_name, registrant_duns	Company that holds the registration. registrant_name is null when it is the name of an individual (flag registrant_name_person_removed).
agent_name, agent_duns	US agent (a company) for foreign establishments. agent_name is null when the published agent is an individual (flag agent_name_person_removed); agent_duns is kept.
exclusion_flag, is_excluded	E / true for firms on the FDA exclusion list (only with includeExcluded).
source, source_file, source_url, source_updated_at	Where the row comes from and when the FDA generated that file (UTC).
first_seen_at, last_seen_at, detected_at	First and last run that saw the row; timestamp of this run.
change_type, changed_fields, previous_values	The change, see above.
quality_flags	Data-quality notes. Rows are flagged, never dropped - full list below.

Quality flags

Flag	Meaning
fei_zero_padded	FEI was published with fewer than 10 digits and was left-padded with zeros (fei_raw has the original).
fei_missing	No FEI published (fei_number is null).
fei_format	FEI is not numeric.
shared_fei	Other rows share this FEI (different D-U-N-S or address).
duns_missing, duns_format	D-U-N-S absent or not 9 digits.
registrant_duns_format	Registrant D-U-N-S not 9 digits.
country_missing	No (XXX) country code at the end of the address.
expiration_invalid	Expiry date missing or not a valid date.
expiration_past	Expiry date is before the run date.
expiration_far	Expiry date is later than the end of next year.
operations_missing	No operations listed (non-excluded firms).
agent_missing_foreign	Non-US establishment with no US agent listed.
agent_details_nonstandard	Agent field did not follow the usual pattern and was parsed best-effort.
agent_name_partial	Part of the agent text looked like a person and was discarded.
agent_name_unavailable	Agent name could not be determined (e.g. only an email was published).
agent_name_person_removed	Agent name looked like an individual and was removed.
registrant_name_person_removed	Registrant name was an individual and was removed.

About the key. One FEI can appear on several rows (about 6% of rows, e.g. an establishment registered under two D-U-N-S numbers or two address variants). Use fei_number + duns_number as the unique key; rows sharing a FEI carry the shared_fei flag.

Personal data is removed

The FDA file includes contact people's names and emails. This Actor never outputs or stores them: establishment contacts, registrant contacts, and the email address and phone number inside the US agent field are all discarded. Registrant and agent names that are individuals (recognised by comparing with the contact names in the file and by name shape) are set to null and flagged. Recognition is best-effort and conservative: a company with a person-like name may occasionally lose its name. Rows are about companies and sites, not people.

The FDA CDN occasionally serves an older copy of the file; the Actor detects it (the file is older than your stored state), retries, and skips the run instead of reporting false reversals.

How much does it cost to use this FDA establishment registration data Actor?

Pay per event. Prices per 1,000 events on the BRONZE tier:

Event	Price
Actor start	$0.01 per run (512 MB)
establishment (snapshot / baseline row)	$1.00 per 1,000 rows
establishment-change (delta row: new / renewed / changed / removed)	$5.00 per 1,000 rows
establishment-preloaded (row of the ready-made snapshot)	$0.50 per 1,000 rows

Apify plan discounts apply to these prices: Free plan +15 %, Silver -15 %, Gold / Platinum / Diamond -30 %.

Real-cost examples

• Full snapshot: about 10,450 rows is roughly $10.45 (about $5.23 as preloaded).
• Typical daily monitor: about 50 changes a day is roughly $0.26 per day ($0.01 start + 50 x $0.005).
• Renewal season: between 9 and 12 October 2026 the delta returned 421 changes, 381 of them renewed. With includeRenewals: false it would have been 40.
• Nothing changed at the FDA: the run finishes in seconds and there is no per-row charge, only the Actor start fee.

Test run: the pre-filled input (100 snapshot rows) on the BRONZE tier is 100 x $0.001 = $0.10, plus the Actor start fee.

Set a maximum charge per run in the Apify run options, or use maxItems: rows not delivered stay pending and arrive in your next delta run.

Data source, frequency and licence

• Source: FDA Drug Establishments Current Registration Site (DECRS) - drls_reg.zip and drls_excluded.zip on accessdata.fda.gov.
• The FDA refreshes the list every business day; schedule this Actor daily.
• The data is a work of the US government and in the public domain (FDA Website Policies). Attribution to the U.S. Food and Drug Administration is appreciated. This Actor is not affiliated with or endorsed by the FDA.
• Registration with the FDA is not an approval or certification of the establishment.

FAQ: FDA drug establishment registration data

How much does a test run cost? With the pre-filled input (snapshot, Spain, 100 rows) on the BRONZE tier: 100 x $0.001 = $0.10 plus the Actor start fee. maxItems and the maximum charge per run in the Apify run options cap your spend.

How often should I run it? The FDA refreshes the list every business day, so a daily schedule in delta mode is enough. If the FDA file did not change, the run finishes in seconds with no per-row charge.

What does removed mean? The establishment is no longer in the FDA list. last_seen_at is the last run that still saw it. The Actor does not tell you why it left the list.

Do filters hide removals? No. The Actor always compares the complete list, so countries and operations only decide which rows you receive.

Does it return people's names or emails? No. Contact names, emails and agent phone numbers are discarded. Registrant and agent names that look like individuals are set to null and flagged (see the personal data section).

Why is fei_number sometimes null? About 2% of firms have no FEI in the FDA file. Use duns_number, or fei_number + duns_number as the unique key where both exist.

Something looks wrong or a field is missing? Open an issue from the Actor page and include the fei_number and duns_number of the row.

Related Rastriq actors

• EudraGMDP Pharma Registry (EMA) - EU licences (WDA, MIA) and GMP/GDP certificates, one row per document.
• EU Pharma Sites Graph - EU/EEA pharma sites from EudraGMDP with their licences grouped, one row per site.
• Europages Scraper - European B2B company directory.

---

Built by Rastriq - reliable data from official registries. Questions or a field you need? Open an issue from the Actor page.