Open Data

Fda Data MCP Server

Connect your account, then chat with AI to run tools.

This server provides access to FDA-related data, including company information, facility inspections, and product compliance details. It is targeted at healthcare professionals, researchers, and businesses needing to navigate regulatory requirements and ensure product safety.

Official server
Agent guide included
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AI Skill
SKILL.md

Domain knowledge for Fda Data — workflow patterns, data models, and gotchas for your AI agent.

This server provides full access to FDA regulatory databases for healthcare professionals, researchers, and businesses navigating compliance requirements. It covers facilities, products, inspections, enforcement actions, and approval records across drugs, devices, and biologics.

Core Capabilities

Company & Facility Intelligence: Look up companies and their FDA-registered facilities with addresses, operations types, and subsidiary relationships. Search across drug (DECRS) and device registration databases by name, location, or parent company structure.

Compliance Monitoring: Access inspection histories, CFR violation citations, warning letters, and enforcement actions. Build compliance timelines combining inspections, citations, and regulatory correspondence for companies and their subsidiaries.

Product Research: Search 510(k) clearances, PMA approvals, drug applications (Drugs@FDA), and NDC directory entries. Cross-reference device classifications with approval records and trace products to manufacturing facilities.

Recall Analysis: Search enforcement actions across drugs, devices, and food products with full-text search capabilities. Trace recalls back to candidate manufacturing facilities with confidence scoring.

Domain Model

The system uses FEI numbers for facility identification, company_id for canonical company records, and tracks relationships between parent companies and subsidiaries. Product codes, NDC numbers, and application numbers serve as key identifiers across different FDA databases.

Key Considerations

Company name matching uses fuzzy search algorithms. The server includes proprietary compliance data not available through openFDA APIs. Many searches support pagination for large result sets. Confidence scoring helps assess data quality for company-facility-product relationships.

Frequently Asked Questions

What is the Fda Data MCP server?

This server provides access to FDA-related data, including company information, facility inspections, and product compliance details. It is targeted at healthcare professionals, researchers, and businesses needing to navigate regulatory requirements and ensure product safety. It provides tools that AI agents can use through the Model Context Protocol (MCP).

How do I connect Fda Data to my AI agent?

Add the MCPBundles server URL to your MCP client configuration (Claude Desktop, Cursor, VS Code, etc.). The URL format is: https://mcp.mcpbundles.com/bundle/fda-data-mcp. Authentication is handled automatically.

What authentication does Fda Data require?

Fda Data uses API Key. Fda Data requires credentials. Connect via MCPBundles and authentication is handled automatically.

Setup Instructions

Connect Fda Data to any MCP client in minutes

https://mcp.mcpbundles.com/bundle/fda-data-mcp

What is MCP?

Model Context Protocol lets AI tools call external capabilities securely through a single URL. This bundle groups tools behind an MCP endpoint that many clients can use.

Use this bundle in 3 steps

  1. Copy the MCP URL above
  2. Open your AI tool and add a new MCP/connector
  3. Paste the URL and follow any auth prompts

Claude Desktop Users

Skip the manual setup! Use the .mcpb file format for one-click installation. Check the Claude Desktop tab for setup instructions.

Pick your tool tab for exact steps

Select ChatGPT, Cursor, Claude Code, or another tab for copy-paste config.

Ready to use Fda Data?

Sign in to connect your credentials and start running tools from the chat.

Fda Data MCP Server & Skill