Start with one company-level summary, then drill into inspections, warning letters, OII documents, import risk, facilities, recalls, and product data without stitching five FDA systems together yourself.
300 free credits · No credit card required · 60 req/min
fda_manufacturing_risk_summary when you want one company-level manufacturing and compliance summary before drilling deeper.Claude / Cowork custom connector:
https://www.regdatalab.com/mcp?apiKey=YOUR_API_KEYPaste this exact URL as one line in Settings > Connectors, then start a new private project chat and enable it from + > Connectors.
Start with one company-level manufacturing risk summary, then drill into inspections, VAI and OAI outcomes, warning letters, OII records, import risk, and facility history.
Assess M&A targets, suppliers, or public companies in hours, not weeks. Pull facility histories, product approvals, recall exposure, and compliance signals into one view before the memo goes out.
Use the same underlying tools for investigations, market research, account planning, and company monitoring after manufacturing questions are answered.
Manufacturing and compliance first, with full coverage across facilities, enforcement actions, approvals, labels, recalls, shortages, and specialty FDA datasets through one MCP endpoint. Browse 37 datasets →
Use fda_manufacturing_risk_summary first when you want a fast company-level manufacturing and compliance read before you spend credits on drill-down tools.
68,000+ company name normalizations baked in. We track the corporate family tree so you don’t have to.
Query a company → see all their facilities → check inspection history → find enforcement actions. Every dataset linked so your agent can follow the trail.
Works with any MCP-compatible agent — Claude, Cowork, custom pipelines, or your own tooling. Single HTTP endpoint, standard protocol.
The docs now tell people how to start, when to use the summary vs drill-down tools, and how to avoid noisy company matches or wasted credits.
Start free with 300 credits. Scale to Pro when you need higher throughput. No surprise bills — you always know exactly what you’re using.
Comprehensive recall data: total counts, Class I/II/III breakdowns, top companies, geographic distribution, and year-over-year trends.
View Statistics →Warning letter volume, compliance action breakdowns, Form 483 observations, top cited companies, and CFR trends.
View Statistics →510(k) clearance data: total decisions, decision code breakdowns, average review time, top companies, and most common product codes.
View 510(k) Stats →Facility inspection data: OAI/VAI/NAI outcomes, top inspected companies, geographic distribution, product types, and center activity.
View Statistics →Get a free API key in seconds and start with a manufacturing risk summary, then drill into the exact FDA evidence you need.