FDA Warning Letter Monitor

Monitor FDA warning letters for regulated companies, products, and compliance topics. Search the full text of every warning letter FDA has posted (for example seafood, CGMP, kratom, 510(k)), newest first, or get the latest letters, with the posted and issue dates, company, issuing office, violation subject, an excerpt, and links to the letter and any response or closeout letter.

Input

• keyword: words to search in the company name, subject and letter text. Leave empty for the latest letters.
• maxItems: how many letters to return, newest first (up to 1,000).

Output

The default dataset contains one record per letter:

• title: company and subject
• company
• publishedAt: date FDA posted the letter (YYYY-MM-DD)
• letterIssueDate: date the letter was issued
• issuingOffice: FDA center or office
• subject: violation subject
• summary: excerpt around your keyword
• sourceUrl: link to the full letter on fda.gov
• responseLetterUrl, closeoutLetterUrl: when posted
• matchedKeyword

Example: {"keyword": "seafood", "maxItems": 25} returns the 25 newest of the 110+ warning letters that mention seafood.

Notes

This Actor is designed as a reliable data product, not a brittle webpage scraper. Always validate regulated or legal data against the linked source before making business decisions.

How to use FDA Warning Letter Monitor

1. Open FDA Warning Letter Monitor on Apify Store and click Try for free.
2. Fill in the input (the form is prefilled with a working example) and click Start.
3. Watch results appear in the Output tab, then download them as JSON, CSV, Excel or HTML, or read them through the API.
4. Optional: save the input as a task and add a schedule to run it automatically, or connect it to your tools with integrations and webhooks.

How much does FDA Warning Letter Monitor cost?

This Actor uses pay-per-event pricing: you pay only for what it delivers, and platform usage is included.

Event	Price
Result (one dataset item)	$0.005 each ($5.00 per 1,000)
Actor start	$5e-05 per run

Set Maximum cost per run in the run options to cap your spend; the Actor stops when the limit is reached. Check the Pricing tab for current prices and plan discounts.

Use FDA Warning Letter Monitor with AI agents (MCP)

Give Claude, ChatGPT, Cursor, VS Code or any MCP client this Actor as a tool through the hosted Apify MCP server. The agent sees the input fields with descriptions and example values, runs the Actor, and reads the results.

MCP server URL (this Actor only):

https://mcp.apify.com/?tools=technicaldost/fda-warning-letter-monitor

Claude Code:

$claude mcp add --transport http apify "https://mcp.apify.com/?tools=technicaldost/fda-warning-letter-monitor" --header "Authorization: Bearer YOUR_APIFY_TOKEN"

Cursor, VS Code, Claude Desktop and other clients (mcp.json or the client's MCP settings):

{
  "mcpServers": {
    "apify": {
      "url": "https://mcp.apify.com/?tools=technicaldost/fda-warning-letter-monitor",
      "headers": { "Authorization": "Bearer YOUR_APIFY_TOKEN" }
    }
  }
}

Clients that support sign-in (such as Claude.ai connectors) can use the URL without a token and log in to Apify instead. Get your token in Apify Console → Settings → API & Integrations, or generate a ready config for your client at mcp.apify.com. In the agent the tool is named technicaldost--fda-warning-letter-monitor; ask it, for example, to "run FDA Warning Letter Monitor with {"maxItems": 10}".

AI agents without an Apify account can also run and pay for this Actor per request with x402 agentic payments.

Run FDA Warning Letter Monitor via API

Run the Actor and get its results in one call (replace YOUR_APIFY_TOKEN):

curl -X POST "https://api.apify.com/v2/acts/technicaldost~fda-warning-letter-monitor/run-sync-get-dataset-items?token=YOUR_APIFY_TOKEN" \
  -H "Content-Type: application/json" \
  -d '{"maxItems": 10}'

Python (pip install apify-client):

from apify_client import ApifyClient

client = ApifyClient("YOUR_APIFY_TOKEN")
run = client.actor("technicaldost/fda-warning-letter-monitor").call(run_input={"maxItems": 10})
for item in client.dataset(run["defaultDatasetId"]).iterate_items():
    print(item)

JavaScript / TypeScript (npm install apify-client):

import { ApifyClient } from 'apify-client';

const client = new ApifyClient({ token: 'YOUR_APIFY_TOKEN' });
const run = await client.actor('technicaldost/fda-warning-letter-monitor').call({"maxItems": 10});
const { items } = await client.dataset(run.defaultDatasetId).listItems();
console.log(items);

Long runs: start them with POST /v2/acts/technicaldost~fda-warning-letter-monitor/runs and fetch the dataset when the run finishes, or receive a webhook.

Integrations

FDA Warning Letter Monitor works with Make, Zapier, n8n, LangChain, Google Sheets, Slack, GitHub and webhooks. Schedule runs in Apify Console and send new results straight to your apps, spreadsheets or AI pipelines.

Related Actors

• SEC Comment Letter Monitor — Find SEC comment-letter correspondence for public companies by CIK
• FDA 510k Device Clearance Monitor — Track recent medical device 510(k) clearances from openFDA
• FDA MAUDE Device Event Monitor — Monitor medical device adverse events from openFDA MAUDE data

FAQ

Can I use FDA Warning Letter Monitor with AI agents like Claude or ChatGPT?

Yes. Connect the Apify MCP server with ?tools=technicaldost/fda-warning-letter-monitor (see above) and the agent can run the Actor and read its results on its own.

Can I call FDA Warning Letter Monitor from my own code?

Yes. Use the REST API, or the official Python and JavaScript clients shown above. Results are available as JSON, CSV, Excel, XML or HTML.

How do I run it on a schedule?

Save your input as a task in Apify Console and add a schedule (for example, daily). Use webhooks or integrations to send each run's results onward.

Is it legal to use this Actor?

It works with publicly available data. Make sure your use complies with the source website's terms and with data protection laws such as GDPR, especially for personal data.

Something doesn't work or I need a feature. What should I do?

Open an issue in the Issues tab on this Actor's page with an example input, and we'll look into it.