DOCS BLOG ABOUT SECURE YOUR MCP

// MCP TOOL REFERENCE

FDA DATA MCP TOOLS

48 tools from the FDA Data MCP MCP Server, categorised by risk level.

View the FDA Data MCP policy → Token cost: 13,902 tokens →

// ALL 48 FDA DATA MCP TOOLS

READ 41 tools

Read fda_bpdr_summary Search FDA's Biological Product Deviation Report annual summary counts. This is summary-level biotech and b... Read fda_citations Search specific CFR violation citations from FDA inspections (Compliance Dashboard data, not available in o... Read fda_clinical_result_letters Search FDA Complete Response Letters (CRLs) — formal refusal-to-approve decisions on drug and biologics app... Read fda_compliance_actions Search FDA compliance enforcement actions (Compliance Dashboard data, not available in openFDA API): Warnin... Read fda_consumer_events Search consumer adverse events for food and cosmetic products by product area, reaction keyword, or date ra... Read fda_device_class Lookup FDA device classification details by product code. Returns device name, device class (I/II/III), med... Read fda_device_recalls Search FDA device recalls by recalling firm (fuzzy match), product code, recall status, or date range. Retu... Read fda_device_supply_status Search FDA's current medical device shortage list and discontinuance list. This is an official FDA supply-c... Read fda_device_udi Search the FDA Unique Device Identification (UDI) database by brand name, company/manufacturer name, produc... Read fda_device_udi_lookup Search the FDA's Global Unique Device Identification Database (GUDID) by device identifier (DI/barcode), de... Read fda_drug_labels Search FDA Structured Product Labeling (SPL) data — full drug package inserts. Filter by drug name, manufac... Read fda_drug_shortages Search FDA drug shortages by generic name, company, status, or availability. Drug shortages signal manufact... Read fda_facility_dossier Compliance-first facility dossier by FEI number. Returns the facility profile plus recent inspections, cita... Read fda_facility_products List device products registered at a facility by FEI number with pagination. Returns product code, propriet... Read fda_get_facility Detailed facility profile by FEI number. Returns: facility name, full address, operations type (Manufacture... Read fda_inspection_observation_summary Search FDA's official annual inspection-observation summary spreadsheets. This is aggregate Form 483 trend ... Read fda_inspections Search FDA inspection history from the Compliance Dashboard (not available in openFDA API). Filter by compa... Read fda_ires_enforcement Search iRES enforcement recalls with cross-references to openFDA enforcement data. Filter by company name (... Read fda_link_subsidiaries Explicitly link existing company records under a parent company for family-level rollups. Use this when nam... Read fda_lookup_company Quick company lookup: facilities (with addresses and operations) and enforcement actions (recalls) for a si... Read fda_product_code_lookup Cross-reference a device product code across classification details, 510(k) clearances, and PMA approvals. ... Read fda_recall_facility_trace Trace a recall to its candidate manufacturing facility with explicit confidence levels. Matches by firm nam... Read fda_search_510k Search FDA 510(k) clearances across all companies. Filter by company name (fuzzy match), product code, deci... Read fda_search_aphis Search APHIS veterinary biologics establishments (animal health facilities) by company, state, or establish... Read fda_search_by_product Search across FDA device and drug datasets by product name (device name, trade name, generic name, or brand... Read fda_search_debarments Search current FDA debarment lists across drug applications, drug imports, and food imports. These are rare... Read fda_search_drugs Search Drugs@FDA applications across all companies. Filter by sponsor name (fuzzy match), application numbe... Read fda_search_enforcement Search FDA enforcement actions (recalls) for drugs, devices, and food across all companies. Filter by compa... Read fda_search_facilities Search FDA-registered facilities by name, city, state, or country. Searches drug (DECRS) and device registr... Read fda_search_family_facilities Search FDA-registered facilities across a parent company and any explicitly linked subsidiaries. Use this w... Read fda_search_import_alerts Search FDA Import Alerts by firm, alert number, red-list versus green-list status, country, keyword, or dat... Read fda_search_ndc Search the National Drug Code (NDC) directory by labeler company, brand name, product NDC, or application n... Read fda_search_nsde Search the National Standard Drug Element (NSDE) database by brand/proprietary name, application number, or... Read fda_search_oii_records Search recent FDA Office of Inspections and Investigations reading-room records by company, FEI, record typ... Read fda_search_opdp_untitled_letters Search official FDA OPDP untitled letters for pharmaceutical promotion and advertising issues. Filter by co... Read fda_search_pma Search FDA Pre-Market Approval (PMA) records across all companies. PMA is required for high-risk (Class III... Read fda_search_recall_text Full-text search across recall reasons and product descriptions using PostgreSQL text search. Finds recalls... Read fda_search_warning_letters Search official FDA warning letters with full-text content from the FDA website. Use keyword search for the... Read fda_substance_lookup Look up FDA substance data by UNII code (exact match) or substance name (fuzzy match). Returns substance na... Read fda_tobacco_problems Search tobacco problem reports by product type or health problem keyword. Date range in YYYYMMDD format. Re... Read fda_vet_events Search veterinary adverse events (animal drug safety reports) by species, drug name, reaction, serious flag...

WRITE 5 tools

Write fda_company_full Comprehensive company profile: facilities (with addresses and operations), enforcement actions (recalls), 5... Write fda_import_refusals Search FDA import refusals (Compliance Dashboard data, not available in openFDA API). Import refusals indic... Write fda_resolve_company Resolve a company name to its canonical company_id and list all known aliases. Returns the canonical slug, ... Write fda_save_aliases Save normalized alias names for a parent company, updating confidence and tracking collisions. Use this for... Write fda_suggest_subsidiaries Discover subsidiary and related company names using FDA datasets first, then supplement with external corpo...

EXECUTE 2 tools

Execute fda_company_compliance_timeline Build a reverse-chronological compliance timeline for one company and any linked subsidiaries. Combines ins... Execute fda_manufacturing_risk_summary Build a manufacturing and compliance summary for one company using FDA facilities, inspections, warning let...

// FAQ

How many tools does the FDA Data MCP MCP server have? +

The FDA Data MCP MCP server exposes 48 tools across 3 categories: Read, Write, Execute.

How do I enforce policies on FDA Data MCP tools? +

Route the FDA Data MCP server through the PolicyLayer gateway. Define allow, deny, or approval rules per tool in the dashboard — they are enforced on every call before it reaches the server.

What risk categories do FDA Data MCP tools fall into? +

FDA Data MCP tools are categorised as Read (41), Write (5), Execute (2). Each category has a recommended default policy.

Let agents act without letting them run wild.

Route your MCP servers through PolicyLayer and every tool call is checked against your policy before it runs — allow, deny, or require approval. Per-identity grants. Full audit log. Live in minutes.

SECURE YOUR MCP →

Free to start. No card required.

4,600+ MCP servers and 31,000+ tools scanned and risk-classified.