FDA Data MCP
io.github.medley/fda-dataClean FDA regulatory data: company resolution, facilities, recalls, inspections, approvals.
Tools · 48
Quick company lookup: facilities (with addresses and operations) and enforcement actions (recalls) for a single company and its known aliases. Costs 1 credit. Excludes: 510(k) clearances, PMA approval…
Search FDA-registered facilities by name, city, state, or country. Searches drug (DECRS) and device registration databases. Returns FEI number, name, address, and source. Use the operations parameter …
Search FDA-registered facilities across a parent company and any explicitly linked subsidiaries. Use this when you know the parent company but the FDA records may sit under child entities like Actavis…
Detailed facility profile by FEI number. Returns: facility name, full address, operations type (Manufacture, API, Repack, Contract Manufacture, etc.), establishment types (Manufacturer, Distributor, S…
Compliance-first facility dossier by FEI number. Returns the facility profile plus recent inspections, citations, warning letters, import refusal history, import-alert mentions, recall context, freshn…
List device products registered at a facility by FEI number with pagination. Returns product code, proprietary name, listing number, and classification details (device name, class, medical specialty).…
Search FDA enforcement actions (recalls) for drugs, devices, and food across all companies. Filter by company name (fuzzy match), recall classification (Class I=most serious/Class II/Class III), date …
Full-text search across recall reasons and product descriptions using PostgreSQL text search. Finds recalls mentioning specific terms (e.g. 'salmonella contamination', 'mislabeled', 'sterility'). Supp…
Resolve a company name to its canonical company_id and list all known aliases. Returns the canonical slug, match confidence, and alias names. Read-only lookup — does not discover new aliases. Related:…
Save normalized alias names for a parent company, updating confidence and tracking collisions. Use this for true name variants of the same company record. If a collision says the alias already belongs…
Explicitly link existing company records under a parent company for family-level rollups. Use this when names like Actavis or Cephalon already belong to their own company_id and should roll up under a…
Discover subsidiary and related company names using FDA datasets first, then supplement with external corporate hierarchy sources (SEC EDGAR Exhibit 21 and GLEIF) when available. Costs 2 credits. Retu…
Build a manufacturing and compliance summary for one company using FDA facilities, inspections, warning letters, OII records, import-risk signals, debarments, and recalls. Use this when you want the c…
Build a reverse-chronological compliance timeline for one company and any linked subsidiaries. Combines inspections, warning letters, import alerts, import refusals, debarments, and recall/enforcement…
Search APHIS veterinary biologics establishments (animal health facilities) by company, state, or establishment type. Returns license number, company name, full address, establishment type (Licensee/P…
Search FDA 510(k) clearances across all companies. Filter by company name (fuzzy match), product code, decision code (e.g., SESE=substantially equivalent), clearance type (Traditional, Special, Abbrev…
Search FDA Pre-Market Approval (PMA) records across all companies. PMA is required for high-risk (Class III) devices. Filter by company name (fuzzy match), product code, and date range. Returns PMA nu…
Lookup FDA device classification details by product code. Returns device name, device class (I/II/III), medical specialty, regulation number, review panel, submission type, and definition. Requires: p…
Cross-reference a device product code across classification details, 510(k) clearances, and PMA approvals. Returns classification info plus paginated lists of all clearances and approvals for that pro…
Search Drugs@FDA applications across all companies. Filter by sponsor name (fuzzy match), application number, brand name, or submission status. Returns application details including products (brand na…
Search the National Drug Code (NDC) directory by labeler company, brand name, product NDC, or application number. Returns labeler name, brand name, generic name, dosage form, route, active ingredients…
Search across FDA device and drug datasets by product name (device name, trade name, generic name, or brand name). Searches device classifications, 510(k) clearances, PMA approvals, and NDC records si…
Trace a recall to its candidate manufacturing facility with explicit confidence levels. Matches by firm name, NDC lookup, and facility registration data. Returns the recall details, matched facility c…
Comprehensive company profile: facilities (with addresses and operations), enforcement actions (recalls), 510(k) clearances, PMA approvals, and drug applications for a single company and its known ali…
Search FDA inspection history from the Compliance Dashboard (not available in openFDA API). Filter by company name (fuzzy match), FEI number, classification (NAI=No Action Indicated, VAI=Voluntary Act…
Search specific CFR violation citations from FDA inspections (Compliance Dashboard data, not available in openFDA API). Filter by company name, FEI number, CFR number, keyword, program area, fiscal ye…
Search FDA compliance enforcement actions (Compliance Dashboard data, not available in openFDA API): Warning Letters, Seizures, and Injunctions. These are the most serious regulatory outcomes, typical…
Search official FDA warning letters with full-text content from the FDA website. Use keyword search for the actual letter body, or filter by company name, issuing office, subject, MARCS-CMS number, pr…
Search official FDA OPDP untitled letters for pharmaceutical promotion and advertising issues. Filter by company, product, issue date, close-out availability, or keyword in the extracted untitled-lett…
Search recent FDA Office of Inspections and Investigations reading-room records by company, FEI, record type, country, establishment type, or publish date. This is official FDA document-index metadata…
Search current FDA debarment lists across drug applications, drug imports, and food imports. These are rare but very high-severity compliance signals for people or firms barred from certain FDA-regula…
Search FDA Import Alerts by firm, alert number, red-list versus green-list status, country, keyword, or date. This is a stronger manufacturing and supplier-risk signal than one-off import refusals bec…
Search FDA's Biological Product Deviation Report annual summary counts. This is summary-level biotech and blood/HCT/P manufacturing signal from official FDA annual reports, not per-event case detail.
Search FDA's current medical device shortage list and discontinuance list. This is an official FDA supply-chain signal for medtech selling, covering shortage categories and permanent discontinuances t…
Search FDA's official annual inspection-observation summary spreadsheets. This is aggregate Form 483 trend data by product area and citation frequency, not a full company-level 483 corpus. Use it to s…
Search FDA import refusals (Compliance Dashboard data, not available in openFDA API). Import refusals indicate products detained at the US border. Filter by company name, FEI number, country code (e.g…
Search iRES enforcement recalls with cross-references to openFDA enforcement data. Filter by company name (fuzzy match), recall number, product type (e.g., Drugs, Devices), or date range. Returns deta…
Search FDA drug shortages by generic name, company, status, or availability. Drug shortages signal manufacturing capacity strain, quality issues, or supply chain disruption. Useful for identifying com…
Search FDA device recalls by recalling firm (fuzzy match), product code, recall status, or date range. Returns device-specific recall details including root cause, event type, and product codes. Compl…
Search consumer adverse events for food and cosmetic products by product area, reaction keyword, or date range (YYYYMMDD format). Returns reports including outcomes, reactions, and product details.
Search veterinary adverse events (animal drug safety reports) by species, drug name, reaction, serious flag, or date range (YYYYMMDD format). Returns event reports including animal details, drug infor…
Search tobacco problem reports by product type or health problem keyword. Date range in YYYYMMDD format. Returns reports including tobacco product details and reported health problems.
Look up FDA substance data by UNII code (exact match) or substance name (fuzzy match). Returns substance name, UNII, substance class, molecular formula, and related details. Use to identify active pha…
Search the National Standard Drug Element (NSDE) database by brand/proprietary name, application number, or package NDC. Returns proprietary name, active ingredients, dosage form, route, and marketing…
Search FDA Complete Response Letters (CRLs) — formal refusal-to-approve decisions on drug and biologics applications. Filter by company name (fuzzy match), application number (e.g., 'NDA 204017'), or …
Search FDA Structured Product Labeling (SPL) data — full drug package inserts. Filter by drug name, manufacturer, application number, or specific label section (e.g., indications_and_usage, warnings, …
Search the FDA Unique Device Identification (UDI) database by brand name, company/manufacturer name, product code, or DI number. Returns device identification data including brand name, company, devic…
Search the FDA's Global Unique Device Identification Database (GUDID) by device identifier (DI/barcode), device name, company name, or brand name. Returns device details including UDI, descriptions, a…
Resources · 1
Entity relationship map describing how identifiers (FEI, company_id, NDC, application_number, product_code) connect across FDA tools.
fda://schema/entities
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How to use
Add to your Claude Desktop / Cursor / Cline MCP config:
{
"mcpServers": {
"fda_data_mcp": {
"url": "https://www.regdatalab.com/mcp",
"transport": "streamable-http"
}
}
}