FDA Data is a remote MCP server that gives an AI agent 48 tools, among them fda_bpdr_summary, fda_citations, fda_clinical_result_letters. It answers at https://www.regdatalab.com/mcp over streamable HTTP, and it listed its tools to an anonymous client, so no sign-in was needed for that. Our probes reached it 6 of 6 times since 11 September 2026; the last check, on 22 October 2026, succeeded.
Clean FDA regulatory data: company resolution, facilities, recalls, inspections, approvals.
Description as the publisher wrote it.
| Tool | What it does |
|---|---|
fda_bpdr_summary | 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. Inputs: fiscal_year, group_name, establishment_type, row_type, keyword, offset |
fda_citations | 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 year, inspection date range, or the parent Inputs: company_name, fei_number, act_cfr_number, keyword, classification, program_area |
fda_clinical_result_letters | 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 letter type. CRLs are significant regula Inputs: company_name, application_number, letter_type, offset, limit |
fda_company_compliance_timeline | 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 events into one dated feed. Inputs: company, limit, verbose |
fda_company_full | 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 aliases. Costs 5 credits. Excludes: inspect Inputs: company, facilities_offset, facilities_limit, enforcement_offset, enforcement_limit, clearances_offset |
fda_compliance_actions | 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, typically following OAI inspections. Filter by Inputs: company_name, fei_number, action_type, date_from, date_to, limit |
fda_consumer_events | 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. Inputs: product_area, reaction, date_from, date_to, offset, limit |
fda_device_class | 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: product code (3-letter code from 510(k), Inputs: product_code |
fda_device_recalls | 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. Complements fda_search_enforcement which cove Inputs: recalling_firm, product_code, recall_status, date_from, date_to, offset |
fda_device_supply_status | 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 that may affect customer operations or pr Inputs: list_type, product_code, manufacturer_name, category, keyword, date_from |
fda_device_udi | 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, device description, product codes, GMDN terms Inputs: brand_name, company_name, product_code, di_number, offset, limit |
fda_device_udi_lookup | 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, and company information. Costs 1 credit. Inputs: device_id, device_name, company_name, brand_name, offset, limit |
fda_drug_labels | 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, adverse_reactions, boxed_warning). Retur Inputs: drug_name, manufacturer, application_number, section, offset, limit |
fda_drug_shortages | 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 companies with operational challenges. Rela Inputs: generic_name, company_name, status, offset, limit |
fda_facility_dossier | 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, freshness, and recommended next tools. Use thi Inputs: fei, evidence_limit |
fda_facility_products | 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). Note: fda_get_facility already includes Inputs: fei, offset, limit |
fda_get_facility | Detailed facility profile by FEI number. Returns: facility name, full address, operations type (Manufacture, API, Repack, Contract Manufacture, etc.), establishment types (Manufacturer, Distributor, Specification Developer, etc.), registran Inputs: fei, products_offset, products_limit |
fda_import_refusals | 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., CN, IN for major API source countries Inputs: company_name, fei_number, country_code, date_from, date_to, limit |
fda_inspection_observation_summary | 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 see which observation areas appear most o Inputs: keyword, product_area, reference_number, cite_id, fiscal_year, offset |
fda_inspections | 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 Action Indicated, OAI=Official Action Indic Inputs: company_name, fei_number, classification_code, state, country, city |
fda_ires_enforcement | 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 detailed recall info including event classif Inputs: company_name, recall_number, product_type, date_from, date_to, offset |
fda_link_subsidiaries | 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 parent like Teva. This preserves alias Inputs: parent_company, subsidiaries |
fda_lookup_company | 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 approvals, drug applications, inspection history Inputs: company, facilities_offset, facilities_limit, enforcement_offset, enforcement_limit |
fda_manufacturing_risk_summary | 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 company-level picture first, then follow Inputs: company, facility_limit, evidence_limit, verbose |
fda_product_code_lookup | 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 product code. Use to understand the regulat Inputs: product_code, clearances_offset, clearances_limit, approvals_offset, approvals_limit |
fda_recall_facility_trace | 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 candidates with FEI numbers and confidenc Inputs: recall_number, firm, product |
fda_resolve_company | 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: fda_suggest_subsidiaries (discover pote Inputs: company |
fda_save_aliases | 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 to another company_id, use fda_link_sub Inputs: parent_company, aliases |
fda_search_510k | 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, Abbreviated), and date range. Returns clearanc Inputs: company, product_code, decision_code, clearance_type, from_date, to_date |
fda_search_aphis | Search APHIS veterinary biologics establishments (animal health facilities) by company, state, or establishment type. Returns license number, company name, full address, establishment type (Licensee/Permittee), divisions, and subsidiaries. Inputs: company, state, type, offset, limit |
fda_search_by_product | 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 simultaneously. Use when you know a produc Inputs: product_name, offset, limit |
fda_search_debarments | 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-regulated activities. Inputs: name, list_type, subject_type, date_from, date_to, offset |
fda_search_drugs | 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 names, dosage forms, active ingredients) a Inputs: company, application_number, brand_name, status, offset, limit |
fda_search_enforcement | 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 range, or status (Ongoing/Terminated). R Inputs: company, classification, from_date, to_date, status, offset |
fda_search_facilities | 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 to filter by manufacturing type (e.g., ' Inputs: company, city, state, country, operations, offset |
fda_search_family_facilities | 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, Watson, or Cephalon. Supports optional Inputs: company, city, state, country, operations, offset |
fda_search_import_alerts | 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 because it captures standing alert status a Inputs: firm_name, alert_number, list_status, country, keyword, date_from |
fda_search_ndc | 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, DEA schedule, listing type, and packag Inputs: company, brand_name, product_ndc, application_number, offset, limit |
fda_search_nsde | 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 information. Related: fda_search_ndc (N Inputs: proprietary_name, application_number, package_ndc, offset, limit |
fda_search_oii_records | 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 with direct links to the posted records Inputs: company_name, fei_number, record_type, establishment_type, country, state |
fda_search_opdp_untitled_letters, fda_search_pma, fda_search_recall_text, fda_search_warning_letters, fda_substance_lookup, fda_suggest_subsidiaries, fda_tobacco_problems, fda_vet_events
Every block below points at https://www.regdatalab.com/mcp. Pick your client and copy.
claude mcp add --transport http fda-data https://www.regdatalab.com/mcp
{
"mcpServers": {
"fda-data": {
"command": "npx",
"args": ["-y", "mcp-remote", "https://www.regdatalab.com/mcp"]
}
}
}{
"mcpServers": {
"fda-data": {
"url": "https://www.regdatalab.com/mcp"
}
}
}{
"servers": {
"fda-data": {
"type": "http",
"url": "https://www.regdatalab.com/mcp"
}
}
}{
"context_servers": {
"fda-data": {
"url": "https://www.regdatalab.com/mcp"
}
}
}{
"mcpServers": {
"fda-data": {
"serverUrl": "https://www.regdatalab.com/mcp"
}
}
}{
"mcpServers": {
"fda-data": {
"url": "https://www.regdatalab.com/mcp"
}
}
}name: FDA Data
version: 0.0.1
schema: v1
mcpServers:
- name: FDA Data
type: streamable-http
url: https://www.regdatalab.com/mcp{
"mcpServers": {
"fda-data": {
"httpUrl": "https://www.regdatalab.com/mcp"
}
}
}{
"mcpServers": {
"fda-data": {
"type": "http",
"url": "https://www.regdatalab.com/mcp"
}
}
}{
"mcpServers": {
"fda-data": {
"url": "https://www.regdatalab.com/mcp"
}
}
}goose://extension?url=https%3A%2F%2Fwww.regdatalab.com%2Fmcp&type=streamable_http&id=fda-data&name=FDA%20Data
It answered our last check on 22 October 2026 in 1262 ms. Over 6 checks since 11 September 2026 it answered 6. Status here comes from Neuronto's own probes, not from the publisher.
48, as returned by the server's own tools/list on 17 September 2026: fda_bpdr_summary, fda_citations, fda_clinical_result_letters, fda_company_compliance_timeline, fda_company_full, fda_compliance_actions, fda_consumer_events, fda_device_class, and 40 more.
It answered our last check on 22 October 2026 in 1262 ms. Over 6 checks since 11 September 2026 it answered 6.
Put the server under mcpServers in ~/.cursor/mcp.json with the URL https://www.regdatalab.com/mcp. The exact JSON is above, with the same setup for Claude Code, Claude Desktop, VS Code, Windsurf, Zed, Gemini CLI and the rest.
It listed its tools to an anonymous client, so reading the tool list needs no key. Individual tools can still ask for credentials in their own inputs.
Publisher: io.github.medley. Endpoint host: www.regdatalab.com. ARD identifier: urn:air:io.github.medley:mcp:fda-data.
First indexed 10 September 2026. The tools are exactly what the server returned; nothing on this page
is inferred from its name. Ranking in Neuronto search is never for sale.