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.

Live tools
Agent guide included

Built by

Fda Data

Opens MCPBundles Studio with this server selected. After sign-in, chat and run tools from the same thread.

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.

Tools in this Server

This server uses the MCP protocol with a live tool list. Tools are discovered when your MCP client connects (often after authentication), so they are not enumerated on this public page. Open Studio or connect from your client to see the tools available to your workspace.

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 MCP tools that your client discovers when it connects (this page may not list every tool name) 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.

How many tools does Fda Data provide?

Fda Data is a remote MCP server. The live tool list is supplied by the server when your MCP client connects, so the count is not fixed on this public page. After you connect in MCPBundles Studio or your client, you will see the tools your session can call. A SKILL.md is still included to guide your agent on capabilities and workflows.

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

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

One-click install:

The link prefills the Add custom connector dialog — you still review the values and click Add, then Connect to complete OAuth.

Or add manually

  1. Open claude.ai → Settings → Connectors.
  2. Click the + button and choose Add custom connector.
  3. Set Name to Fda Data and paste the MCP URL into Remote MCP server URL.
  4. Click Add. Fda Data will appear under Not connected — select it and click Connect to complete OAuth.
Name: Fda Data
Remote MCP server URL: https://mcp.mcpbundles.com/bundle/fda-data-mcp
Authentication: OAuth

Custom connectors at claude.ai require a paid Claude plan (Pro, Max, Team, or Enterprise).

Maintain this listing

Operate Fda Data? You can take over the listing's metadata.

Operate Fda Data?

Take over this listing's metadata — name, description, category, logo, website, contact email, and skill content. Verification is a 6-digit code we email to one of the maintainer addresses your server already publishes in /.well-known/security.txt or /.well-known/mcpbundles.json. Free, takes about a minute.

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Fda Data MCP Server & Skill — Live Tools