Inspections, warning letters, recalls, import alerts, 510(k) and PMA clearances, and drug shortages — cross-referenced by company and facility, served through one MCP endpoint and REST API your agents can trust.
50 credits to start · 300/month once verified · 50-call public demo · no card
Demo API key
fda_demo_GKNDjUOjPbhLZZVPvRHDlY3zP_H3HXzTMRbHVD_I5rg50 free calls to try — no signup required.
$ regdatalab company-summary --name “Pfizer”
Illustrative response. Live figures vary by company and date.
37
FDA datasets
48
MCP tools
377K+
Company name normalizations
REST + MCP
One endpoint, two protocols
Trusted by teams at
Regulatory affairs · compliance
Track a company's enforcement posture across inspections, warning letters, recalls, and import alerts. Start with one company-level summary, then follow the trail into the underlying evidence.
Deal teams · analysts
Assess an acquisition target, supplier, or public issuer in hours. Pull facility histories, product approvals, and recall exposure into a single view before the memo goes out.
Quality · supplier risk · CMC
Vet a contract manufacturer or resolve a supply question against the facility's real inspection record — Form 483 citations, OAI outcomes, and open recalls, tied to the FEI.
| Dataset | Query it for | Primary tool |
|---|---|---|
| Facility inspections | NAI / VAI / OAI outcomes, Form 483 citations, inspection history | fda_inspections |
| Warning & untitled letters | Full enforcement text, cited CFR, issuing office and dates | fda_search_warning_letters |
| Recalls & enforcement | Class I–III recalls, reason, status, and recall-to-facility trace | fda_search_enforcement |
| Import alerts & refusals | Detention-without-exam listings and border refusal history | fda_search_import_alerts |
| 510(k) & PMA | Device clearances, approvals, product codes, and review time | fda_search_510k |
| Shortages & labels | Active drug shortages, NDC directory, and structured labeling | fda_drug_shortages |
RegDataLab speaks the Model Context Protocol over a single HTTP endpoint. Wire it into Claude, Cursor, ChatGPT, or your own pipeline — the same tools, the same key.
claude mcp add regdatalab https://www.regdatalab.com/mcp \
--transport http --header "Authorization: Bearer <your key>"Provision a key in seconds. Start with 50 demo calls, unlock 300 credits a month by verifying your email.