openFDA alternative
openFDA is FDA's own free API for recalls, adverse events, labels, NDCs and device clearances. RegDataLab uses openFDA as one of its sources and adds the compliance records openFDA does not publish, such as inspection outcomes, Form 483 citations, warning letters, import alerts and debarments, matched to companies and facilities and ready to ask in Claude or ChatGPT.
No key needed for the check. For the full record, connect RegDataLab or use the API.
Side by side
| openFDA | RegDataLab | |
|---|---|---|
| Run by | U.S. FDA | Independent (not affiliated with FDA) |
| Price | Free | Free tier, then paid plans |
| Recalls, adverse events, labels, NDC, 510(k), PMA | Yes | Yes, from openFDA and other FDA sources |
| Inspection outcomes (NAI, VAI, OAI) | No | Yes |
| Form 483 citations and documents | No | Yes |
| Warning letters, seizures, injunctions | No | Yes |
| Import alerts, import refusals, debarments | No | Yes |
| Company and facility matching | Search by name per dataset | One company family with its FEI numbers across datasets |
| Use in Claude, ChatGPT, Cursor | Build it yourself | Hosted MCP server |
When to use which
Use openFDA when
You need one public dataset, such as adverse events or drug labels, and are happy to write the queries and joins yourself.
Use RegDataLab when
You are checking a supplier or company and need its inspections, 483s, warning letters, recalls and import history together.
Same primary sources
Every record links back to its fda.gov source, so an answer can be checked against FDA's own page.
Built for AI tools
One MCP server URL gives Claude, ChatGPT and coding agents the tools; no API client to write.
Ask it in Claude or ChatGPT
- Check [supplier]'s FDA record: inspections, Form 483s, warning letters and recalls.
- Which of these three suppliers has the cleanest FDA inspection history?
- Did [company] have an import alert or refusal in the last two years?
50 credits now, 300 credits a month once you verify your email.
Questions
- Is RegDataLab built on openFDA?
- Partly. RegDataLab uses openFDA datasets alongside FDA's data dashboard and other FDA sources, then normalizes names and links records to companies and facilities.
- Does openFDA have warning letters or Form 483s?
- No. openFDA covers recalls, adverse events, labels, NDC codes and device data. Warning letters, inspection classifications and Form 483 citations come from other FDA sources, which RegDataLab includes.
- Is openFDA free?
- Yes. openFDA is free from FDA. RegDataLab has a free tier and paid plans for more monthly credits.
- How do I use RegDataLab in Claude or ChatGPT?
- Add https://www.regdatalab.com/mcp as a custom connector (Claude: Customize, Connectors, Add custom connector; ChatGPT: add a custom MCP server with OAuth), sign in with your key, then ask in plain English. 50 credits now, 300 credits a month once you verify your email.
- Is RegDataLab part of the FDA?
- No. RegDataLab is an independent data product built on public FDA records. It is not affiliated with, endorsed by, or sponsored by the U.S. Food and Drug Administration.
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