FDA Supplier Watch - Warning Letters & Import Alerts by Company avatar

FDA Supplier Watch - Warning Letters & Import Alerts by Company

Pricing

from $2.00 / 1,000 company checkeds

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FDA Supplier Watch - Warning Letters & Import Alerts by Company

FDA Supplier Watch - Warning Letters & Import Alerts by Company

Did a supplier just get an FDA warning letter or land on an import alert? Give company names, get new FDA warning letters and import-alert (Red List) firms, only what is new since your last run, with a link to FDA recall data. Name matching is fuzzy: review hits.

Pricing

from $2.00 / 1,000 company checkeds

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Developer

mohamed alaya

mohamed alaya

Maintained by Community

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1

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15 days ago

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Give company names; get their FDA warning letters and import-alert (Red List) listings, then only the new ones on every later run. For pharma, device and food quality and supplier-qualification teams who need to know when a supplier gets in trouble with the FDA.

It uses the FDA's public warning letters database and the public import alert pages. Each company row also links to openFDA recall data.

Quick start - three copy-paste inputs

Demo (empty input works):

{}

Your supplier list, scheduled weekly:

{
"companies": ["Teva", "Hikma", "Sun Pharmaceutical", "Aurobindo"],
"importAlerts": ["66-40", "66-41", "66-79", "99-34"],
"stateStoreName": "acme-supplier-watch",
"webhookUrl": "https://hooks.slack.com/services/XXX/YYY/ZZZ"
}

Food and supplement suppliers, warning letters plus food import alerts:

{ "companies": ["Nature's Bounty", "Herbalife"], "importAlerts": ["54-14", "99-32", "99-35", "99-23"], "historyMonths": 36 }

Input guide

FieldMeaning
companiesNames to watch. All words of a name must appear in the FDA company name; Inc, LLC, Ltd, Corp... are ignored; "dba" names are matched on both sides.
sourceswarning-letters and/or import-alerts.
importAlertsImport alert numbers to search (66-40 drug GMP, 66-41, 66-79, 99-34, 99-32, 99-35, 54-14 ...). ALL searches every alert (150+ large pages, slow).
historyMonthsFor a company checked for the first time, existing items posted in this window are reported (flagged isBaseline); older ones are only counted.
stateStoreNameMemory store, same name every run.
webhookUrlOptional POST of new actions.

Output

company-check (one per company): counts of letters and listings, newThisRun, matchedNames, and recallSearchUrls (openFDA drug, device and food enforcement searches for that firm: open them for recall data).

new-action (one per new item):

FieldMeaning
actionwarning-letter or import-alert
matchedName, matchScoreThe FDA name that matched, and a 0-1 similarity (1 = same words)
issuingOffice, subject, letterIssueDate, postedDateWarning letter facts
alertNumber, subject, country, address, postedDateImport alert facts (date the firm was listed)
urlFDA page
isBaselinetrue for history reported on a company's first check

Sample row:

{"type":"new-action","company":"Babikian Healthcare Products","action":"import-alert","matchedName":"BABIKIAN HEALTHCARE PRODUCTS","matchScore":1,"alertNumber":"66-40","postedDate":"2026-06-22","country":"ARMENIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html"}

Use it with

  • Run openFDA recall searches from recallSearchUrls, or pair it with a recall monitor for the products you buy.
  • Webhook to Slack or Teams so QA hears about a new letter the day it is posted.

FAQ

Is a match proof it is the same company? No. Matching is by name only. Check the matchedName, address and country before acting.

Does it cover Form 483s, inspections or recalls? No. Warning letters and import alerts only; recalls are linked, not copied.

How new is "new"? The FDA posts warning letters on Tuesdays; import alert pages are updated as firms are added.

Honest limits

  • Only the import alerts you list are searched (the default list covers the main drug and device ones).
  • Names that are too short or generic (a single word under 4 letters) never match.
  • If an FDA page cannot be read, that source is skipped for the run and an error row says so; nothing is marked as seen for it.

Price

$0.002 per company checked, $0.01 per new FDA action found. Watching 50 suppliers weekly with 2 new items costs about $0.12 per run.