Check any company's or site's FDA inspections, 483s, warning letters and recalls in one place.
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io.github.medley/fda-data is an MCP server that check any company's or site's FDA inspections, 483s, warning letters and recalls in one place. Its tool list has not been published yet over http, requires no API key, and scores 43/100 on MCPpedia's security, maintenance and efficiency rubric.
Config is the same across clients - only the file and path differ.
{
"mcpServers": {
"fda-data": {
"url": "https://www.regdatalab.com/mcp",
"headers": {
"Authorization": "Bearer YOUR_API_KEY"
}
}
}
}Are you the author?
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Check any company's or site's FDA inspections, 483s, warning letters and recalls in one place.
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Five weighted categories - click any category to see the underlying evidence.
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Public FDA compliance records (inspections, Form 483s, warning letters, recalls) linked by company and site, for Claude, ChatGPT, any MCP client or API.
This is the public install and discovery repo for RegDataLab – FDA Compliance Data, the hosted MCP server at https://www.regdatalab.com/mcp. It has 51 read-only tools over 35 public FDA datasets, and every record links back to its FDA source. The npm package keeps the name fda-data-mcp. The private backend, ingestion system, and production data pipeline are not open-sourced here.
Ask about a supplier by the name you know. RegDataLab finds the subsidiaries FDA files under other names, then answers across all of them, with a link to the FDA source on every record.
You ask: "Check Baxter as a supplier."
One call to fda_manufacturing_risk_summary searches Baxter and 21 linked companies, including Hillrom and Welch Allyn:
| Across the Baxter family | |
|---|---|
| Sites | 65 FDA-registered or inspected sites |
| Inspections | 201 on record: 103 NAI, 72 VAI, 26 OAI. Latest OAI: Round Lake, IL, April 2026 |
| Warning letters | 15, most recent September 29, 2026 |
| Form 483s | Latest published: Baxter Healthcare, Round Lake and Baxter Oncology GmbH |
| Recalls | 703 distinct recalls, 324 in the last 5 years |
| Import alerts | 1 red-list entry on Import Alert 66-40 (2014) |
From a real answer on November 12, 2026. Searching FDA's own sites for "Baxter" would miss the Hillrom and Welch Allyn records. NAI, VAI and OAI are FDA's inspection outcomes: no action, voluntary action, official action indicated.
Paste this into a terminal with Claude Code. It uses the shared demo key from the regdatalab.com home page:
claude mcp add regdatalab-demo https://www.regdatalab.com/mcp \
--transport http \
--header "Authorization: Bearer fda_demo_GKNDjUOjPbhLZZVPvRHDlY3zP_H3HXzTMRbHVD_I5rg"
Then ask: "Check Baxter as a supplier." The demo key is shared by every visitor and capped at 20 requests per minute and 50 credits per IP address. For your own key, sign up free (50 credits, no card), or add the bare URL and sign in as shown under Quick Start.
The same question in ChatGPT, from question to sourced answer:

Full walkthrough (4 minutes): regdatalab-chatgpt-review-walkthrough.mp4. No terminal? Look up any company at regdatalab.com.

https://www.regdatalab.com/mcphttps://www.regdatalab.com/.well-known/mcp.json