How is this different from openFDA?

openFDA publishes recalls, adverse events, 510(k)s and labels as separate endpoints. RegDataLab adds inspection outcomes, Form 483 citations, warning letters, import alerts and debarments, and matches all of it to companies and facilities.

How do I authenticate?

Sign up for a free key and send it as Authorization: Bearer YOUR_API_KEY. Never put a key in a URL.

How much does the API cost?

50 credits now, 300 credits a month once you verify your email. Paid plans add more monthly credits; see the pricing page.

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.

API

FDA data API

RegDataLab is an HTTPS API over public FDA records. Send a JSON-RPC request with your key and get back inspections, citations, warning letters, recalls, clearances, approvals and import records, already matched to companies and facilities. The same API runs as an MCP server, so AI agents can call it directly.

No key needed for the check. For the full record, connect RegDataLab or use the API.

What you can look up

Company matching built in

Messy firm names resolve to one company family with its facilities and FEI numbers, so you do not join FDA datasets yourself.

Records openFDA does not carry

Inspection classifications, Form 483 citations, warning letters, import alerts and refusals and debarments sit next to openFDA's recalls, 510(k)s and labels.

Simple auth and credits

Send Authorization: Bearer with your key. Record searches cost 1 credit and company summaries a few more, up to 60 requests a minute.

Source links on every record

Results carry the fda.gov link for each record, so a report can cite the primary source.

Tools to call first

fda_manufacturing_risk_summary for one company's compliance picture
fda_compare_companies to put 2 to 5 suppliers side by side
fda_search_warning_letters, fda_citations and fda_inspections for the raw records

Get free API key Connect in 2 minutes

50 credits now, 300 credits a month once you verify your email.

Browse the records

Questions

How is this different from openFDA?: openFDA publishes recalls, adverse events, 510(k)s and labels as separate endpoints. RegDataLab adds inspection outcomes, Form 483 citations, warning letters, import alerts and debarments, and matches all of it to companies and facilities.
How do I authenticate?: Sign up for a free key and send it as Authorization: Bearer YOUR_API_KEY. Never put a key in a URL.
How much does the API cost?: 50 credits now, 300 credits a month once you verify your email. Paid plans add more monthly credits; see the pricing page.
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.