FDA Data MCP provides manufacturing-first FDA intelligence for AI agents, consolidating data from inspections, compliance actions, warning letters, OII records, import risk, facilities, and product approvals through a single MCP endpoint. It eliminates the need to manually stitch together multiple FDA systems, offering normalized company data and cross-referenced datasets for comprehensive analysis.
Freemium
from $29/month
How to use FDA Data MCP?
Connect the MCP server to your AI agent (like Claude Desktop) using an API key. Start by requesting a company-level manufacturing risk summary with `fda_manufacturing_risk_summary`. Then, drill down into specific datasets like inspection histories, warning letters, or product approvals. Use it for due diligence, compliance monitoring, or research by querying companies and following linked data trails across facilities and enforcement actions.
FDA Data MCP 's Core Features
Provides a unified MCP endpoint with 44 live tools covering 37+ FDA datasets, including facilities, enforcement actions, approvals, labels, recalls, and shortages.
Offers a starting-point summary tool (`fda_manufacturing_risk_summary`) for a quick company-level compliance overview before detailed investigation.
Includes over 68,000 pre-normalized company names with corporate family tracking, simplifying entity resolution.
Features fully cross-referenced datasets, allowing agents to query a company, see its facilities, check inspection history, and find linked enforcement actions seamlessly.
Built on the standard MCP protocol, compatible with Claude Desktop, custom pipelines, and other MCP-enabled agents via a single HTTP endpoint.
Provides practical documentation with guidance on starting workflows, choosing between summary and drill-down tools, and optimizing credit usage.
Operates on a transparent credit-based system with a free tier (300 credits), scalable paid plans, and clear per-request costs without surprise billing.
FDA Data MCP 's Use Cases
Manufacturing & Compliance teams can start with a company risk summary, then drill into inspections, warning letters, OII records, and import risk for supplier or internal audits.
Due Diligence and Investment professionals assess M&A targets or public companies in hours by consolidating facility histories, product approvals, and compliance signals.
Researchers and Journalists investigate market trends, company histories, or regulatory compliance for in-depth reports and articles.
Sales and Account teams use the data for account planning, market research, and monitoring client or prospect manufacturing status.
Quality Assurance and Regulatory Affairs staff monitor facility inspection outcomes (OAI/VAI/NAI) and track enforcement actions across their organization or partners.
Supply Chain Managers evaluate supplier risk by checking facility compliance histories, recall exposure, and import alerts linked to specific companies.
FDA Data MCP 's Pricing
Free
$0/month
300 credits/month, 60 requests/min, full FDA MCP toolset, self-serve signup
Starter
$29/month
2,000 credits/month, 120 requests/min, full FDA MCP toolset, email support
Pro
$99/month
10,000 credits/month, 300 requests/min, full FDA MCP toolset, priority support
Enterprise
$249/month
50,000 credits/month, 600 requests/min, full FDA MCP toolset, dedicated support
