RegDataLab MCP Server

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 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 inspection's classification (NAI/VAI/OAI). CFR matching is hierarchical and section-anchored: pass '21 CFR 211.68' or '211.68' and it matches '21 CFR 211.68', '21 CFR 211.68(a)', '21 CFR 211.68(b)' but NOT '21 CFR 211.680' or '21 CFR 211.6'. Each row carries the parent inspection's classification (inspection_classification / inspection_classification_code) joined by inspection_id, plus inspection_id and a best-effort source_url deep link. Returns the cited regulation, short and long descriptions of the finding, and inspection dates. Related: fda_inspections (inspection classification and dates by FEI), fda_search_warning_letters (official warning letters for the same FEI), fda_compliance_actions (warning letters that may reference these citations).

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 regulatory events indicating application deficiencies. Related: fda_search_drugs (drug application data including approval status).

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.

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: inspection history, citations, compliance actions (warning letters), facility-level product lists, import refusals, and family rollups across separate child company records. For family rollups: call fda_suggest_subsidiaries first, then use fda_save_aliases for true same-company names or fda_link_subsidiaries for distinct child companies. Related: fda_suggest_subsidiaries (discover subsidiaries), fda_link_subsidiaries (create explicit family links), fda_get_facility (per-facility products, operations type, risk summary by FEI), fda_inspections (inspection history by FEI or company), fda_citations (CFR violations by FEI), fda_compliance_actions (warning letters/seizures by FEI or company), fda_search_aphis (animal health facilities for vet companies), fda_drug_shortages (active drug shortages).

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 company name, FEI number, action type (Warning Letter/Seizure/Injunction), or date range. Related: fda_inspections (underlying inspection data by FEI), fda_citations (CFR violations cited in these actions).

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.

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), PMA, or device product listings). Related: fda_product_code_lookup (cross-reference across 510(k) and PMA), fda_search_510k (clearances for this product code), fda_search_pma (PMA approvals for this product code).

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 covers all product types. Related: fda_search_enforcement (all recalls including drugs), fda_recall_facility_trace (trace to manufacturing facility), fda_device_class (product code details).

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 product availability.

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, sterilization info, and premarket submissions. Related: fda_device_class (classification details by product code), fda_search_510k (clearances by product code).

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.

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). Returns complete label text for matching sections. Related: fda_search_drugs (application-level data), fda_search_ndc (NDC product details).

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. Related: fda_search_drugs (drug application data by company), fda_search_ndc (NDC-level product details).

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 this when you want the fastest FEI-level manufacturing risk view instead of the broader product-focused facility profile.

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 products — use this only when paginating through large product lists. Drug products are not linked by FEI; use fda_search_ndc with company name instead. Requires: FEI number.

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.), registrant and owner/operator info, DUNS number, registration expiry, enforcement history (recalls), device products with classification, and a facility_risk_summary (inspection counts by classification, warning letters, last inspection date). Requires: FEI number — get it from fda_search_facilities or fda_company_full. Excludes: full inspection details and citations. Related: fda_inspections (inspection history by FEI), fda_citations (CFR violations by FEI), fda_compliance_actions (warning letters/seizures by FEI), fda_import_refusals (import refusal history by FEI), fda_facility_products (paginate large product lists).

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), or date range. Critical for evaluating international manufacturing sites and supply chain risk. Related: fda_get_facility (facility details by FEI), fda_inspections (inspection history by FEI).

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 often in Drugs, Devices, Foods, and other FDA program areas.

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 Indicated — most serious), state, country, city, or date range. Date filters apply to inspection_end_date. OAI inspections typically lead to warning letters. Related: fda_citations (specific CFR violations from inspections by FEI), fda_compliance_actions (warning letters following OAI inspections by FEI).

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 classification, product codes, and quantities. Related: fda_search_enforcement (openFDA recall data), fda_recall_facility_trace (trace recall to manufacturing facility).

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 collision safety while making manufacturing and facility summaries family-aware.

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, and subsidiary data. Related: fda_company_full (adds clearances/approvals/drugs for 5 credits), fda_suggest_subsidiaries (discover related entities), fda_get_facility (per-facility products and operations by FEI).

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 the linked granular tools for deeper inspection.

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 regulatory landscape for a specific device type. Requires: product code.

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 confidence scores, and match methodology. Provide either recall_number (from fda_search_enforcement or fda_ires_enforcement) OR firm (+ optional product) to resolve the best-matching recall automatically. Related: fda_get_facility (full detail for matched FEI), fda_inspections (inspection history for matched FEI), fda_compliance_actions (warning letters for matched FEI).

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 potential subsidiaries not yet aliased), fda_company_full (full profile using the resolved name).

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_subsidiaries instead of forcing the alias. Typical workflow: call fda_suggest_subsidiaries first, review results, then call this tool with confirmed same-entity alias names.

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 clearance number (K-number), applicant, device name, decision date, and product code. Related: fda_device_class (product code details and classification), fda_product_code_lookup (cross-reference a product code across 510(k) and PMA), fda_search_pma (PMA approvals for higher-risk devices).

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. Covers vaccine manufacturers, diagnostic kit producers, and other veterinary biological product facilities. Related: fda_vet_events (veterinary adverse events by species/drug).

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 product name but not which dataset it's in. Returns matches from each dataset with product codes and company names.

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.

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) and submissions (approval dates, status). Related: fda_search_ndc (NDC-level product details including labeler and packaging), fda_drug_labels (structured product labeling/package inserts), fda_clinical_result_letters (Complete Response Letters — FDA refusal-to-approve decisions), fda_drug_shortages (active drug shortage data).

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). Returns recall details including product description, reason, and distribution pattern. Related: fda_recall_facility_trace (trace a recall to its manufacturing facility by recall_number), fda_ires_enforcement (iRES recall data with cross-references), fda_device_recalls (device-specific recall data).

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., 'Contract Manufacture', 'API', 'Repack'). Use country filter (ISO code: US, DE, IN, CN, IE) to map a company's global manufacturing footprint. Excludes: products at facility, inspection history, enforcement actions. Related: fda_get_facility (full facility detail by FEI including products and operations type), fda_inspections (inspection data by FEI), fda_citations (CFR violations by FEI).

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 city, state, country, and operations filters.

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 and the specific firms currently listed under each alert.

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 packaging details. Drug products are not linked by FEI; use this tool with company name to find drugs at a company. Related: fda_search_drugs (application-level data with submissions), fda_drug_labels (full product labeling), fda_search_nsde (NSDE cross-reference).

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 (NDC directory), fda_search_drugs (Drugs@FDA application data).

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, plus incremental extracted document text when available, useful for finding recent 483-style inspection evidence by account.

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-letter text when available.

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 number, applicant, trade name, decision date, and product code. Related: fda_device_class (product code details), fda_search_510k (510(k) clearances for lower-risk devices), fda_product_code_lookup (cross-reference a product code).

Full-text search across recall reasons and product descriptions using PostgreSQL text search. Finds recalls mentioning specific terms (e.g. 'salmonella contamination', 'mislabeled', 'sterility'). Supports multi-word queries ranked by relevance. Filter by classification, product_type, or date range. Related: fda_search_enforcement (search by company name, classification, status), fda_recall_facility_trace (trace a recall to its manufacturing facility).

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, product type, or letter issue date. Adds prospecting filters: status (open|responded|closed, derived from response/closeout dates), letter_category (CGMP-manufacturing | BIMO | listing | OPDP/promotion | 503B/compounding | import — heuristic, derived from issuing_office/subject/product_type), and violation_theme (cgmp_subsystem | data_integrity | validation | bimo | listing | promotion — keyword/FTS-derived over subject+body). Set dedupe=true to collapse near-identical letters sharing a MARCS-CMS case number to one canonical row. Each row exposes derived status and letter_category, plus fei_number for one-hop navigation to fda_citations and fda_inspections. This adds narrative context beyond fda_compliance_actions, which only contains dashboard metadata. NOTE: violation_theme and letter_category are best-effort heuristics over free-text fields; keyword cannot be scoped to a parsed cited-violations sub-section because the corpus only stores subject + full letter body.

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 pharmaceutical ingredients.

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. Returns FDA name candidates, evidence-backed company-record suggestions, EDGAR subsidiaries, GLEIF subsidiaries, existing aliases, and facility coverage stats. The coverage.unlinked_feis count indicates how many facilities may be missing from the current alias set. The workflow is conservative and explainable: it validates candidates against FDA company records instead of auto-linking them. Note: EDGAR and GLEIF may lag recent acquisitions or divestitures, so missing external results do not rule out FDA-visible subsidiaries. Recommended workflow: 1. fda_suggest_subsidiaries, 2. fda_link_subsidiaries for distinct child companies or fda_save_aliases for true same-company variants, 3. fda_manufacturing_risk_summary or fda_search_family_facilities. Related: fda_link_subsidiaries (persist explicit family links), fda_save_aliases (persist same-entity names), fda_manufacturing_risk_summary (family-aware company rollup), fda_search_family_facilities (family-aware FEI search).

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.

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 information, and adverse reactions. Related: fda_search_aphis (veterinary biologics facilities and establishments).