このMCPでできること
Searches and analyzes FDA data covering drugs, devices, facilities, inspections, recalls, approvals, shortages, enforcement, and regulatory compliance.
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fda_bpdr_summary
Search BPDR Annual 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.
読み取り専用
冪等
入力スキーマ
{'type': 'object', '$schema': 'http://json-schema.org/draft-07/schema#', 'properties': {'limit': {'type': 'integer', 'default': 100, 'maximum': 500, 'minimum': 1, 'description': 'Max results to return (1-500)'}, 'offset': {'type': 'integer', 'default': 0, 'maximum': 9007199254740991, 'minimum': 0, 'description': 'Result offset for pagination'}, 'keyword': {'type': 'string', 'maxLength': 500, 'description': 'Keyword to search in group_name or establishment_type'}, 'row_type': {'enum': ['establishment', 'subtotal', 'total'], 'type': 'string', 'description': 'Whether the row is a normal establishment line, subtotal, or total'}, 'group_name': {'type': 'string', 'maxLength': 200, 'description': 'Group name, for example Licensed Non-Blood Manufacturers'}, 'fiscal_year': {'type': 'integer', 'maximum': 2100, 'minimum': 2000, 'description': 'Metric fiscal year, for example 2024'}, 'establishment_type': {'type': 'string', 'maxLength': 200, 'description': 'Establishment type, for example Vaccine or 351 HCT/P'}}}
fda_citations
Search Inspection 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 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).
読み取り専用
冪等
入力スキーマ
{'type': 'object', '$schema': 'http://json-schema.org/draft-07/schema#', 'properties': {'limit': {'type': 'integer', 'default': 100, 'maximum': 500, 'minimum': 1, 'description': 'Max results to return (1-500)'}, 'offset': {'type': 'integer', 'default': 0, 'maximum': 9007199254740991, 'minimum': 0, 'description': 'Result offset for pagination'}, 'date_to': {'type': 'string', 'pattern': '^\\d{4}-\\d{2}-\\d{2}$', 'description': 'End date for inspection_end_date range (YYYY-MM-DD)'}, 'keyword': {'type': 'string', 'maxLength': 500, 'description': 'Keyword to search in citation descriptions'}, 'date_from': {'type': 'string', 'pattern': '^\\d{4}-\\d{2}-\\d{2}$', 'description': 'Start date for inspection_end_date range (YYYY-MM-DD)'}, 'fei_number': {'type': 'string', 'pattern': '^\\d{1,10}$', 'description': 'FDA Establishment Identifier (FEI number)'}, 'fiscal_year': {'type': 'integer', 'maximum': 2100, 'minimum': 2000, 'description': 'Fiscal year of the inspection'}, 'company_name': {'type': 'string', 'maxLength': 500, 'description': 'Company name (fuzzy match)'}, 'program_area': {'type': 'string', 'maxLength': 200, 'description': 'Program area (partial match, e.g. Drugs, Devices, Foods)'}, 'act_cfr_number': {'type': 'string', 'maxLength': 200, 'description': "CFR section, section-anchored prefix match (e.g. '21 CFR 211.68' or '211.68' matches 211.68, 211.68(a), 211.68(b) but not 211.680 or 211.6)"}, 'classification': {'enum': ['NAI', 'VAI', 'OAI'], 'type': 'string', 'description': 'Parent inspection classification (NAI=No Action Indicated, VAI=Voluntary Action Indicated, OAI=Official Action Indicated)'}}}
fda_clinical_result_letters
Search Complete Response Letters
Search FDA Complete Response Letters (CRLs) â formal refusal-to-approve decisions on drug and biologics applications. Filter by company name (fuzzy match), application number (e.g., 'NDA 204017'), or letter type. CRLs are significant regulatory events indicating application deficiencies. Related: fda_search_drugs (drug application data including approval status).
読み取り専用
冪等
入力スキーマ
{'type': 'object', '$schema': 'http://json-schema.org/draft-07/schema#', 'properties': {'limit': {'type': 'integer', 'default': 100, 'maximum': 500, 'minimum': 1, 'description': 'Max results to return (1-500)'}, 'offset': {'type': 'integer', 'default': 0, 'maximum': 9007199254740991, 'minimum': 0, 'description': 'Result offset for pagination'}, 'letter_type': {'type': 'string', 'maxLength': 500, 'description': "Letter type filter (e.g. 'COMPLETE RESPONSE')"}, 'company_name': {'type': 'string', 'maxLength': 500, 'description': 'Company name (fuzzy match)'}, 'application_number': {'type': 'string', 'maxLength': 500, 'description': "Application number (searches array, e.g. 'NDA 204017')"}}}
fda_company_compliance_timeline
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.
読み取り専用
冪等
入力スキーマ
{'type': 'object', '$schema': 'http://json-schema.org/draft-07/schema#', 'required': ['company'], 'properties': {'limit': {'type': 'integer', 'default': 25, 'maximum': 100, 'minimum': 1, 'description': 'Maximum number of combined timeline events to return'}, 'company': {'type': 'string', 'maxLength': 500, 'description': 'Company name to build the timeline for'}, 'verbose': {'type': 'boolean', 'default': False, 'description': 'When false (default), suppress the inline alias dump and collapse per-dataset data_freshness to a single top-level as_of. Set true for the full block.'}}}
fda_company_full
Full Company Profile
Comprehensive company profile: facilities (with addresses and operations), enforcement actions (recalls), 510(k) clearances, PMA approvals, and drug applications for a single company and its known aliases. Costs 5 credits. Excludes: inspection history, citations, compliance actions (warning letters), facility-level product lists, import refusals, and family rollups across separate child company records. For family rollups: call fda_suggest_subsidiaries first, then use fda_save_aliases for true same-company names or fda_link_subsidiaries for distinct child companies. Related: fda_suggest_subsidiaries (discover subsidiaries), fda_link_subsidiaries (create explicit family links), fda_get_facility (per-facility products, operations type, risk summary by FEI), fda_inspections (inspection history by FEI or company), fda_citations (CFR violations by FEI), fda_compliance_actions (warning letters/seizures by FEI or company), fda_search_aphis (animal health facilities for vet companies), fda_drug_shortages (active drug shortages).
読み取り専用
冪等
入力スキーマ
{'type': 'object', '$schema': 'http://json-schema.org/draft-07/schema#', 'required': ['company'], 'properties': {'company': {'type': 'string', 'maxLength': 500, 'description': 'Company name to look up'}, 'drugs_limit': {'type': 'integer', 'default': 50, 'maximum': 500, 'minimum': 1, 'description': 'Drug applications result limit'}, 'drugs_offset': {'type': 'integer', 'default': 0, 'maximum': 9007199254740991, 'minimum': 0, 'description': 'Drug applications result offset'}, 'approvals_limit': {'type': 'integer', 'default': 50, 'maximum': 500, 'minimum': 1, 'description': 'PMA approvals result limit'}, 'approvals_offset': {'type': 'integer', 'default': 0, 'maximum': 9007199254740991, 'minimum': 0, 'description': 'PMA approvals result offset'}, 'clearances_limit': {'type': 'integer', 'default': 50, 'maximum': 500, 'minimum': 1, 'description': '510(k) clearances result limit'}, 'facilities_limit': {'type': 'integer', 'default': 50, 'maximum': 500, 'minimum': 1, 'description': 'Facilities result limit'}, 'clearances_offset': {'type': 'integer', 'default': 0, 'maximum': 9007199254740991, 'minimum': 0, 'description': '510(k) clearances result offset'}, 'enforcement_limit': {'type': 'integer', 'default': 50, 'maximum': 500, 'minimum': 1, 'description': 'Enforcement result limit'}, 'facilities_offset': {'type': 'integer', 'default': 0, 'maximum': 9007199254740991, 'minimum': 0, 'description': 'Facilities result offset'}, 'enforcement_offset': {'type': 'integer', 'default': 0, 'maximum': 9007199254740991, 'minimum': 0, 'description': 'Enforcement result offset'}}}
fda_compliance_actions
Search 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 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).
読み取り専用
冪等
入力スキーマ
{'type': 'object', '$schema': 'http://json-schema.org/draft-07/schema#', 'properties': {'limit': {'type': 'integer', 'default': 100, 'maximum': 500, 'minimum': 1, 'description': 'Max results to return (1-500)'}, 'date_to': {'type': 'string', 'pattern': '^\\d{4}-\\d{2}-\\d{2}$', 'description': 'End date for action_taken_date range (YYYY-MM-DD)'}, 'date_from': {'type': 'string', 'pattern': '^\\d{4}-\\d{2}-\\d{2}$', 'description': 'Start date for action_taken_date range (YYYY-MM-DD)'}, 'fei_number': {'type': 'string', 'pattern': '^\\d{1,10}$', 'description': 'FDA Establishment Identifier (FEI number)'}, 'action_type': {'enum': ['Warning Letter', 'Seizure', 'Injunction'], 'type': 'string', 'description': 'Compliance action type'}, 'company_name': {'type': 'string', 'maxLength': 500, 'description': 'Company name (fuzzy match)'}}}
fda_consumer_events
Search Consumer Adverse 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.
読み取り専用
冪等
入力スキーマ
{'type': 'object', '$schema': 'http://json-schema.org/draft-07/schema#', 'properties': {'limit': {'type': 'integer', 'default': 100, 'maximum': 500, 'minimum': 1, 'description': 'Max results to return (1-500)'}, 'offset': {'type': 'integer', 'default': 0, 'maximum': 9007199254740991, 'minimum': 0, 'description': 'Result offset for pagination'}, 'date_to': {'type': 'string', 'pattern': '^\\d{8}$', 'description': 'End date for date_created (YYYYMMDD)'}, 'reaction': {'type': 'string', 'maxLength': 500, 'description': 'Reaction keyword (searches reactions array)'}, 'date_from': {'type': 'string', 'pattern': '^\\d{8}$', 'description': 'Start date for date_created (YYYYMMDD)'}, 'product_area': {'enum': ['food', 'cosmetic'], 'type': 'string', 'description': 'Filter by product area: food or cosmetic'}}}
fda_device_class
Device Classification Lookup
Lookup FDA device classification details by product code. Returns device name, device class (I/II/III), medical specialty, regulation number, review panel, submission type, and definition. Requires: product code (3-letter code from 510(k), PMA, or device product listings). Related: fda_product_code_lookup (cross-reference across 510(k) and PMA), fda_search_510k (clearances for this product code), fda_search_pma (PMA approvals for this product code).
読み取り専用
冪等
入力スキーマ
{'type': 'object', '$schema': 'http://json-schema.org/draft-07/schema#', 'required': ['product_code'], 'properties': {'product_code': {'type': 'string', 'pattern': '^[A-Z]{2,3}$', 'maxLength': 5, 'description': 'Device product code'}}}
fda_device_recalls
Search Device Recalls
Search FDA device recalls by recalling firm (fuzzy match), product code, recall status, or date range. Returns device-specific recall details including root cause, event type, and product codes. Complements fda_search_enforcement which covers all product types. Related: fda_search_enforcement (all recalls including drugs), fda_recall_facility_trace (trace to manufacturing facility), fda_device_class (product code details).
読み取り専用
冪等
入力スキーマ
{'type': 'object', '$schema': 'http://json-schema.org/draft-07/schema#', 'properties': {'limit': {'type': 'integer', 'default': 100, 'maximum': 500, 'minimum': 1, 'description': 'Max results to return (1-500)'}, 'offset': {'type': 'integer', 'default': 0, 'maximum': 9007199254740991, 'minimum': 0, 'description': 'Result offset for pagination'}, 'date_to': {'type': 'string', 'pattern': '^\\d{4}-\\d{2}-\\d{2}$', 'description': 'End date for event_date_initiated (YYYY-MM-DD)'}, 'date_from': {'type': 'string', 'pattern': '^\\d{4}-\\d{2}-\\d{2}$', 'description': 'Start date for event_date_initiated (YYYY-MM-DD)'}, 'product_code': {'type': 'string', 'pattern': '^[A-Z]{2,3}$', 'maxLength': 5, 'description': 'Product code'}, 'recall_status': {'type': 'string', 'maxLength': 500, 'description': 'Recall status'}, 'recalling_firm': {'type': 'string', 'maxLength': 500, 'description': 'Recalling firm name (fuzzy match)'}}}
fda_device_supply_status
Search Device Shortages And Discontinuances
Search FDA's current medical device shortage list and discontinuance list. This is an official FDA supply-chain signal for medtech selling, covering shortage categories and permanent discontinuances that may affect customer operations or product availability.
読み取り専用
冪等
入力スキーマ
{'type': 'object', '$schema': 'http://json-schema.org/draft-07/schema#', 'properties': {'limit': {'type': 'integer', 'default': 100, 'maximum': 500, 'minimum': 1, 'description': 'Max results to return (1-500)'}, 'offset': {'type': 'integer', 'default': 0, 'maximum': 9007199254740991, 'minimum': 0, 'description': 'Result offset for pagination'}, 'date_to': {'type': 'string', 'pattern': '^\\d{4}-\\d{2}-\\d{2}$', 'description': 'End date for latest_date range (YYYY-MM-DD)'}, 'keyword': {'type': 'string', 'maxLength': 500, 'description': 'Keyword to search descriptions, device names, notes, or reasons'}, 'category': {'type': 'string', 'maxLength': 500, 'description': 'Device category'}, 'date_from': {'type': 'string', 'pattern': '^\\d{4}-\\d{2}-\\d{2}$', 'description': 'Start date for latest_date range (YYYY-MM-DD)'}, 'list_type': {'enum': ['shortage', 'discontinuance'], 'type': 'string', 'description': 'Whether to search the shortage list or discontinuance list'}, 'product_code': {'type': 'string', 'maxLength': 50, 'description': 'FDA product code, for example DSQ or MKJ'}, 'manufacturer_name': {'type': 'string', 'maxLength': 500, 'description': 'Manufacturer name (fuzzy match, discontinuance list only)'}}}
fda_device_udi
Search 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, sterilization info, and premarket submissions. Related: fda_device_class (classification details by product code), fda_search_510k (clearances by product code).
読み取り専用
冪等
入力スキーマ
{'type': 'object', '$schema': 'http://json-schema.org/draft-07/schema#', 'properties': {'limit': {'type': 'integer', 'default': 20, 'maximum': 100, 'minimum': 1, 'description': 'Result limit'}, 'offset': {'type': 'integer', 'default': 0, 'maximum': 9007199254740991, 'minimum': 0, 'description': 'Result offset'}, 'di_number': {'type': 'string', 'maxLength': 100, 'description': 'Device Identifier (DI) number'}, 'brand_name': {'type': 'string', 'maxLength': 500, 'description': 'Device brand name (fuzzy match)'}, 'company_name': {'type': 'string', 'maxLength': 500, 'description': 'Company/manufacturer name (fuzzy match)'}, 'product_code': {'type': 'string', 'pattern': '^[A-Z]{2,3}$', 'maxLength': 5, 'description': 'FDA product code (3-letter code, e.g. OVE)'}}}
fda_device_udi_lookup
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.
読み取り専用
冪等
入力スキーマ
{'type': 'object', '$schema': 'http://json-schema.org/draft-07/schema#', 'properties': {'limit': {'type': 'integer', 'default': 100, 'maximum': 500, 'minimum': 1, 'description': 'Max results to return (1-500)'}, 'offset': {'type': 'integer', 'default': 0, 'maximum': 9007199254740991, 'minimum': 0, 'description': 'Result offset for pagination'}, 'device_id': {'type': 'string', 'maxLength': 100, 'description': 'Device Identifier (DI) â\x80\x94 exact barcode/GTIN lookup'}, 'brand_name': {'type': 'string', 'maxLength': 500, 'description': 'Brand name (fuzzy search)'}, 'device_name': {'type': 'string', 'maxLength': 500, 'description': 'Device/brand name (fuzzy search)'}, 'company_name': {'type': 'string', 'maxLength': 500, 'description': 'Company/manufacturer name (fuzzy search)'}}}
fda_drug_labels
Search Drug Labels
Search FDA Structured Product Labeling (SPL) data â full drug package inserts. Filter by drug name, manufacturer, application number, or specific label section (e.g., indications_and_usage, warnings, adverse_reactions, boxed_warning). Returns complete label text for matching sections. Related: fda_search_drugs (application-level data), fda_search_ndc (NDC product details).
読み取り専用
冪等
入力スキーマ
{'type': 'object', '$schema': 'http://json-schema.org/draft-07/schema#', 'properties': {'limit': {'type': 'integer', 'default': 20, 'maximum': 100, 'minimum': 1, 'description': 'Result limit'}, 'offset': {'type': 'integer', 'default': 0, 'maximum': 9007199254740991, 'minimum': 0, 'description': 'Result offset'}, 'section': {'type': 'string', 'maxLength': 100, 'description': 'Specific label section to return (e.g. indications_and_usage, warnings, adverse_reactions)'}, 'drug_name': {'type': 'string', 'maxLength': 500, 'description': 'Brand or generic drug name (fuzzy match)'}, 'manufacturer': {'type': 'string', 'maxLength': 500, 'description': 'Manufacturer name (fuzzy match)'}, 'application_number': {'type': 'string', 'maxLength': 100, 'description': 'NDA or ANDA application number'}}}
fda_drug_shortages
Search 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. Related: fda_search_drugs (drug application data by company), fda_search_ndc (NDC-level product details).
読み取り専用
冪等
入力スキーマ
{'type': 'object', '$schema': 'http://json-schema.org/draft-07/schema#', 'properties': {'limit': {'type': 'integer', 'default': 100, 'maximum': 500, 'minimum': 1, 'description': 'Max results to return (1-500)'}, 'offset': {'type': 'integer', 'default': 0, 'maximum': 9007199254740991, 'minimum': 0, 'description': 'Result offset for pagination'}, 'status': {'type': 'string', 'maxLength': 500, 'description': 'Shortage status filter'}, 'company_name': {'type': 'string', 'maxLength': 500, 'description': 'Company name (fuzzy match)'}, 'generic_name': {'type': 'string', 'maxLength': 500, 'description': 'Generic drug name (fuzzy match)'}}}
fda_facility_dossier
Facility Compliance Dossier
Compliance-first facility dossier by FEI number. Returns the facility profile plus recent inspections, citations, warning letters, import refusal history, import-alert mentions, recall context, freshness, and recommended next tools. Use this when you want the fastest FEI-level manufacturing risk view instead of the broader product-focused facility profile.
読み取り専用
冪等
入力スキーマ
{'type': 'object', '$schema': 'http://json-schema.org/draft-07/schema#', 'required': ['fei'], 'properties': {'fei': {'type': 'string', 'pattern': '^\\d{1,10}$', 'description': 'FDA Establishment Identifier (FEI number)'}, 'evidence_limit': {'type': 'integer', 'default': 5, 'maximum': 20, 'minimum': 1, 'description': 'Number of recent evidence rows to return per evidence section'}}}
fda_facility_products
Facility Products
List device products registered at a facility by FEI number with pagination. Returns product code, proprietary name, listing number, and classification details (device name, class, medical specialty). Note: fda_get_facility already includes products â use this only when paginating through large product lists. Drug products are not linked by FEI; use fda_search_ndc with company name instead. Requires: FEI number.
読み取り専用
冪等
入力スキーマ
{'type': 'object', '$schema': 'http://json-schema.org/draft-07/schema#', 'required': ['fei'], 'properties': {'fei': {'type': 'string', 'pattern': '^\\d{1,10}$', 'description': 'FDA Establishment Identifier (FEI number)'}, 'limit': {'type': 'integer', 'default': 100, 'maximum': 500, 'minimum': 1, 'description': 'Max results to return (1-500)'}, 'offset': {'type': 'integer', 'default': 0, 'maximum': 9007199254740991, 'minimum': 0, 'description': 'Result offset for pagination'}}}
fda_get_facility
Facility Detail
Detailed facility profile by FEI number. Returns: facility name, full address, operations type (Manufacture, API, Repack, Contract Manufacture, etc.), establishment types (Manufacturer, Distributor, Specification Developer, etc.), registrant and owner/operator info, DUNS number, registration expiry, enforcement history (recalls), device products with classification, and a facility_risk_summary (inspection counts by classification, warning letters, last inspection date). Requires: FEI number â get it from fda_search_facilities or fda_company_full. Excludes: full inspection details and citations. Related: fda_inspections (inspection history by FEI), fda_citations (CFR violations by FEI), fda_compliance_actions (warning letters/seizures by FEI), fda_import_refusals (import refusal history by FEI), fda_facility_products (paginate large product lists).
読み取り専用
冪等
入力スキーマ
{'type': 'object', '$schema': 'http://json-schema.org/draft-07/schema#', 'required': ['fei'], 'properties': {'fei': {'type': 'string', 'pattern': '^\\d{1,10}$', 'description': 'FDA Establishment Identifier (FEI number)'}, 'products_limit': {'type': 'integer', 'default': 200, 'maximum': 500, 'minimum': 1, 'description': 'Products result limit'}, 'products_offset': {'type': 'integer', 'default': 0, 'maximum': 9007199254740991, 'minimum': 0, 'description': 'Products result offset'}}}
fda_import_refusals
Search Import Refusals
Search FDA import refusals (Compliance Dashboard data, not available in openFDA API). Import refusals indicate products detained at the US border. Filter by company name, FEI number, country code (e.g., CN, IN for major API source countries), or date range. Critical for evaluating international manufacturing sites and supply chain risk. Related: fda_get_facility (facility details by FEI), fda_inspections (inspection history by FEI).
読み取り専用
冪等
入力スキーマ
{'type': 'object', '$schema': 'http://json-schema.org/draft-07/schema#', 'properties': {'limit': {'type': 'integer', 'default': 100, 'maximum': 500, 'minimum': 1, 'description': 'Max results to return (1-500)'}, 'date_to': {'type': 'string', 'pattern': '^\\d{4}-\\d{2}-\\d{2}$', 'description': 'End date for refusal_date range (YYYY-MM-DD)'}, 'date_from': {'type': 'string', 'pattern': '^\\d{4}-\\d{2}-\\d{2}$', 'description': 'Start date for refusal_date range (YYYY-MM-DD)'}, 'fei_number': {'type': 'string', 'pattern': '^\\d{1,10}$', 'description': 'FDA Establishment Identifier (FEI number)'}, 'company_name': {'type': 'string', 'maxLength': 500, 'description': 'Company name (fuzzy match)'}, 'country_code': {'type': 'string', 'maxLength': 500, 'description': 'ISO country code (e.g. CN, IN)'}}}
fda_inspection_observation_summary
Search Inspection Observation Summary
Search FDA's official annual inspection-observation summary spreadsheets. This is aggregate Form 483 trend data by product area and citation frequency, not a full company-level 483 corpus. Use it to see which observation areas appear most often in Drugs, Devices, Foods, and other FDA program areas.
読み取り専用
冪等
入力スキーマ
{'type': 'object', '$schema': 'http://json-schema.org/draft-07/schema#', 'properties': {'limit': {'type': 'integer', 'default': 100, 'maximum': 500, 'minimum': 1, 'description': 'Max results to return (1-500)'}, 'offset': {'type': 'integer', 'default': 0, 'maximum': 9007199254740991, 'minimum': 0, 'description': 'Result offset for pagination'}, 'cite_id': {'type': 'string', 'maxLength': 50, 'description': 'FDA citation identifier from the spreadsheet'}, 'keyword': {'type': 'string', 'maxLength': 500, 'description': 'Full-text query across short and long citation descriptions'}, 'fiscal_year': {'type': 'integer', 'maximum': 2100, 'minimum': 2000, 'description': 'Fiscal year of the spreadsheet'}, 'product_area': {'type': 'string', 'maxLength': 200, 'description': 'Product or program area (e.g. Drugs, Devices, Foods)'}, 'reference_number': {'type': 'string', 'maxLength': 200, 'description': 'Regulatory citation reference number (e.g. 21 CFR 211.192)'}}}
fda_inspections
Search 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 Indicated â 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).
読み取り専用
冪等
入力スキーマ
{'type': 'object', '$schema': 'http://json-schema.org/draft-07/schema#', 'properties': {'city': {'type': 'string', 'maxLength': 500, 'description': 'City name (exact match)'}, 'limit': {'type': 'integer', 'default': 100, 'maximum': 500, 'minimum': 1, 'description': 'Max results to return (1-500)'}, 'state': {'type': 'string', 'maxLength': 10, 'description': 'State code (e.g., CA, NY)'}, 'country': {'type': 'string', 'maxLength': 10, 'description': 'Country code (e.g., US, DE)'}, 'date_to': {'type': 'string', 'pattern': '^\\d{4}-\\d{2}-\\d{2}$', 'description': 'End date for inspection_end_date range (YYYY-MM-DD)'}, 'date_from': {'type': 'string', 'pattern': '^\\d{4}-\\d{2}-\\d{2}$', 'description': 'Start date for inspection_end_date range (YYYY-MM-DD)'}, 'fei_number': {'type': 'string', 'pattern': '^\\d{1,10}$', 'description': 'FDA Establishment Identifier (FEI number)'}, 'company_name': {'type': 'string', 'maxLength': 500, 'description': 'Company name (fuzzy match)'}, 'classification_code': {'enum': ['NAI', 'VAI', 'OAI'], 'type': 'string', 'description': 'Inspection classification code'}}}
fda_ires_enforcement
Search 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 classification, product codes, and quantities. Related: fda_search_enforcement (openFDA recall data), fda_recall_facility_trace (trace recall to manufacturing facility).
読み取り専用
冪等
入力スキーマ
{'type': 'object', '$schema': 'http://json-schema.org/draft-07/schema#', 'properties': {'limit': {'type': 'integer', 'default': 100, 'maximum': 500, 'minimum': 1, 'description': 'Max results to return (1-500)'}, 'offset': {'type': 'integer', 'default': 0, 'maximum': 9007199254740991, 'minimum': 0, 'description': 'Result offset for pagination'}, 'date_to': {'type': 'string', 'pattern': '^\\d{4}-\\d{2}-\\d{2}$', 'description': 'End date for enforcement_report_date range (YYYY-MM-DD)'}, 'date_from': {'type': 'string', 'pattern': '^\\d{4}-\\d{2}-\\d{2}$', 'description': 'Start date for enforcement_report_date range (YYYY-MM-DD)'}, 'company_name': {'type': 'string', 'maxLength': 500, 'description': 'Company name (fuzzy match)'}, 'product_type': {'type': 'string', 'maxLength': 500, 'description': 'Product type (e.g. Drugs, Devices)'}, 'recall_number': {'type': 'string', 'maxLength': 500, 'description': 'Recall number'}}}
fda_link_subsidiaries
Link Subsidiaries
Explicitly link existing company records under a parent company for family-level rollups. Use this when names like Actavis or Cephalon already belong to their own company_id and should roll up under a parent like Teva. This preserves alias collision safety while making manufacturing and facility summaries family-aware.
冪等
入力スキーマ
{'type': 'object', '$schema': 'http://json-schema.org/draft-07/schema#', 'required': ['parent_company', 'subsidiaries'], 'properties': {'subsidiaries': {'type': 'array', 'items': {'type': 'object', 'required': ['company'], 'properties': {'notes': {'type': 'string', 'maxLength': 2000, 'description': 'Optional notes about the relationship'}, 'source': {'type': 'string', 'maxLength': 500, 'description': 'Relationship source identifier'}, 'company': {'type': 'string', 'maxLength': 500, 'description': 'Existing company name to link under the parent'}, 'confidence': {'type': 'number', 'maximum': 1, 'minimum': 0, 'description': 'Relationship confidence between 0 and 1'}}}, 'maxItems': 100, 'minItems': 1, 'description': 'Subsidiary company records to link'}, 'parent_company': {'type': 'string', 'maxLength': 500, 'description': 'Parent company that should own the family rollup'}}}
fda_lookup_company
Company Lookup
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).
読み取り専用
冪等
入力スキーマ
{'type': 'object', '$schema': 'http://json-schema.org/draft-07/schema#', 'required': ['company'], 'properties': {'company': {'type': 'string', 'maxLength': 500, 'description': 'Company name to look up'}, 'facilities_limit': {'type': 'integer', 'default': 200, 'maximum': 500, 'minimum': 1, 'description': 'Facilities result limit'}, 'enforcement_limit': {'type': 'integer', 'default': 200, 'maximum': 500, 'minimum': 1, 'description': 'Enforcement result limit'}, 'facilities_offset': {'type': 'integer', 'default': 0, 'maximum': 9007199254740991, 'minimum': 0, 'description': 'Facilities result offset'}, 'enforcement_offset': {'type': 'integer', 'default': 0, 'maximum': 9007199254740991, 'minimum': 0, 'description': 'Enforcement result offset'}}}
fda_manufacturing_risk_summary
Manufacturing Risk Summary
Build a manufacturing and compliance summary for one company using FDA facilities, inspections, warning letters, OII records, import-risk signals, debarments, and recalls. Use this when you want the company-level picture first, then follow the linked granular tools for deeper inspection.
読み取り専用
冪等
入力スキーマ
{'type': 'object', '$schema': 'http://json-schema.org/draft-07/schema#', 'required': ['company'], 'properties': {'company': {'type': 'string', 'maxLength': 500, 'description': 'Company name to summarize'}, 'verbose': {'type': 'boolean', 'default': False, 'description': 'When false (default), suppress the inline alias dump and collapse per-dataset data_freshness to a single top-level as_of. Set true for the full block.'}, 'evidence_limit': {'type': 'integer', 'default': 5, 'maximum': 25, 'minimum': 1, 'description': 'Max recent records to return per evidence section'}, 'facility_limit': {'type': 'integer', 'default': 10, 'maximum': 50, 'minimum': 1, 'description': 'Max facilities to return'}}}
fda_product_code_lookup
Product Code Cross-Reference
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.
読み取り専用
冪等
入力スキーマ
{'type': 'object', '$schema': 'http://json-schema.org/draft-07/schema#', 'required': ['product_code'], 'properties': {'product_code': {'type': 'string', 'pattern': '^[A-Z]{2,3}$', 'maxLength': 5, 'description': 'Device product code'}, 'approvals_limit': {'type': 'integer', 'default': 100, 'maximum': 500, 'minimum': 1, 'description': 'PMA approvals result limit'}, 'approvals_offset': {'type': 'integer', 'default': 0, 'maximum': 9007199254740991, 'minimum': 0, 'description': 'PMA approvals result offset'}, 'clearances_limit': {'type': 'integer', 'default': 100, 'maximum': 500, 'minimum': 1, 'description': '510(k) clearances result limit'}, 'clearances_offset': {'type': 'integer', 'default': 0, 'maximum': 9007199254740991, 'minimum': 0, 'description': '510(k) clearances result offset'}}}
fda_recall_facility_trace
Recall-to-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 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).
読み取り専用
冪等
入力スキーマ
{'type': 'object', '$schema': 'http://json-schema.org/draft-07/schema#', 'properties': {'firm': {'type': 'string', 'maxLength': 500, 'description': 'Recalling firm name (fuzzy). Convenience path: resolves the best-matching recall when recall_number is omitted.'}, 'product': {'type': 'string', 'maxLength': 500, 'description': 'Optional product keyword to narrow firm-based resolution (matches product_description).'}, 'recall_number': {'type': 'string', 'maxLength': 500, 'description': 'Recall number (preferred). If omitted, provide firm to auto-resolve.'}}}
fda_resolve_company
Resolve Company Name
Resolve a company name to its canonical company_id and list all known aliases. Returns the canonical slug, match confidence, and alias names. Read-only lookup â does not discover new aliases. Related: fda_suggest_subsidiaries (discover potential subsidiaries not yet aliased), fda_company_full (full profile using the resolved name).
読み取り専用
冪等
入力スキーマ
{'type': 'object', '$schema': 'http://json-schema.org/draft-07/schema#', 'required': ['company'], 'properties': {'company': {'type': 'string', 'maxLength': 500, 'description': 'Company name to resolve'}}}
fda_save_aliases
Save Company 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_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.
冪等
入力スキーマ
{'type': 'object', '$schema': 'http://json-schema.org/draft-07/schema#', 'required': ['parent_company', 'aliases'], 'properties': {'aliases': {'type': 'array', 'items': {'type': 'object', 'required': ['alias'], 'properties': {'alias': {'type': 'string', 'maxLength': 500, 'description': 'Alias name to associate with the company'}, 'source': {'type': 'string', 'maxLength': 500, 'description': 'Alias source identifier'}, 'confidence': {'type': 'number', 'maximum': 1, 'minimum': 0, 'description': 'Alias confidence between 0 and 1'}}}, 'maxItems': 100, 'minItems': 1, 'description': 'Alias entries to save'}, 'parent_company': {'type': 'string', 'maxLength': 500, 'description': 'Canonical parent company name'}}}
fda_search_510k
Search 510(k) Clearances
Search FDA 510(k) clearances across all companies. Filter by company name (fuzzy match), product code, decision code (e.g., SESE=substantially equivalent), clearance type (Traditional, Special, Abbreviated), and date range. Returns clearance number (K-number), applicant, device name, decision date, and product code. Related: fda_device_class (product code details and classification), fda_product_code_lookup (cross-reference a product code across 510(k) and PMA), fda_search_pma (PMA approvals for higher-risk devices).
読み取り専用
冪等
入力スキーマ
{'type': 'object', '$schema': 'http://json-schema.org/draft-07/schema#', 'properties': {'limit': {'type': 'integer', 'default': 100, 'maximum': 500, 'minimum': 1, 'description': 'Max results to return (1-500)'}, 'offset': {'type': 'integer', 'default': 0, 'maximum': 9007199254740991, 'minimum': 0, 'description': 'Result offset for pagination'}, 'company': {'type': 'string', 'maxLength': 500, 'description': 'Company name (fuzzy search)'}, 'to_date': {'type': 'string', 'pattern': '^\\d{4}-\\d{2}-\\d{2}$', 'description': 'End date for decision_date range (YYYY-MM-DD)'}, 'from_date': {'type': 'string', 'pattern': '^\\d{4}-\\d{2}-\\d{2}$', 'description': 'Start date for decision_date range (YYYY-MM-DD)'}, 'product_code': {'type': 'string', 'pattern': '^[A-Z]{2,3}$', 'maxLength': 5, 'description': 'Device product code'}, 'decision_code': {'type': 'string', 'maxLength': 500, 'description': 'Decision code (e.g., SESE, SESD)'}, 'clearance_type': {'type': 'string', 'maxLength': 500, 'description': 'Clearance type (e.g., Traditional, Special)'}}}
fda_search_aphis
Search APHIS Vet Biologics
Search APHIS veterinary biologics establishments (animal health facilities) by company, state, or establishment type. Returns license number, company name, full address, establishment type (Licensee/Permittee), divisions, and subsidiaries. Covers vaccine manufacturers, diagnostic kit producers, and other veterinary biological product facilities. Related: fda_vet_events (veterinary adverse events by species/drug).
読み取り専用
冪等
入力スキーマ
{'type': 'object', '$schema': 'http://json-schema.org/draft-07/schema#', 'properties': {'type': {'enum': ['Licensee', 'Permittee'], 'type': 'string', 'description': 'Establishment type'}, 'limit': {'type': 'integer', 'default': 100, 'maximum': 500, 'minimum': 1, 'description': 'Max results to return (1-500)'}, 'state': {'type': 'string', 'maxLength': 10, 'description': 'State code (e.g., CA, NY)'}, 'offset': {'type': 'integer', 'default': 0, 'maximum': 9007199254740991, 'minimum': 0, 'description': 'Result offset for pagination'}, 'company': {'type': 'string', 'maxLength': 500, 'description': 'Company name (fuzzy search)'}}}
fda_search_by_product
Search by Product Name
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.
読み取り専用
冪等
入力スキーマ
{'type': 'object', '$schema': 'http://json-schema.org/draft-07/schema#', 'required': ['product_name'], 'properties': {'limit': {'type': 'integer', 'default': 100, 'maximum': 500, 'minimum': 1, 'description': 'Max results to return (1-500)'}, 'offset': {'type': 'integer', 'default': 0, 'maximum': 9007199254740991, 'minimum': 0, 'description': 'Result offset for pagination'}, 'product_name': {'type': 'string', 'maxLength': 500, 'description': 'Product or brand name (fuzzy search)'}}}
fda_search_debarments
Search FDA Debarments
Search current FDA debarment lists across drug applications, drug imports, and food imports. These are rare but very high-severity compliance signals for people or firms barred from certain FDA-regulated activities.
読み取り専用
冪等
入力スキーマ
{'type': 'object', '$schema': 'http://json-schema.org/draft-07/schema#', 'properties': {'name': {'type': 'string', 'maxLength': 500, 'description': 'Person or firm name (fuzzy match)'}, 'limit': {'type': 'integer', 'default': 100, 'maximum': 500, 'minimum': 1, 'description': 'Max results to return (1-500)'}, 'offset': {'type': 'integer', 'default': 0, 'maximum': 9007199254740991, 'minimum': 0, 'description': 'Result offset for pagination'}, 'date_to': {'type': 'string', 'pattern': '^\\d{4}-\\d{2}-\\d{2}$', 'description': 'End date for effective_date range (YYYY-MM-DD)'}, 'date_from': {'type': 'string', 'pattern': '^\\d{4}-\\d{2}-\\d{2}$', 'description': 'Start date for effective_date range (YYYY-MM-DD)'}, 'list_type': {'enum': ['drug_applications', 'drug_imports', 'food_imports'], 'type': 'string', 'description': 'Debarment list type'}, 'subject_type': {'enum': ['person', 'firm'], 'type': 'string', 'description': 'Whether the record is a person or a firm'}}}
fda_search_drugs
Search Drug Applications
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 â FDA refusal-to-approve decisions), fda_drug_shortages (active drug shortage data).
読み取り専用
冪等
入力スキーマ
{'type': 'object', '$schema': 'http://json-schema.org/draft-07/schema#', 'properties': {'limit': {'type': 'integer', 'default': 100, 'maximum': 500, 'minimum': 1, 'description': 'Max results to return (1-500)'}, 'offset': {'type': 'integer', 'default': 0, 'maximum': 9007199254740991, 'minimum': 0, 'description': 'Result offset for pagination'}, 'status': {'type': 'string', 'maxLength': 500, 'description': 'Submission status (searches submissions JSONB)'}, 'company': {'type': 'string', 'maxLength': 500, 'description': 'Company name (fuzzy search)'}, 'brand_name': {'type': 'string', 'maxLength': 500, 'description': 'Brand name (searches products JSONB)'}, 'application_number': {'type': 'string', 'maxLength': 500, 'description': 'Application number'}}}
fda_search_enforcement
Search Recalls
Search FDA enforcement actions (recalls) for drugs, devices, and food across all companies. Filter by company name (fuzzy match), recall classification (Class I=most serious/Class II/Class III), date range, or status (Ongoing/Terminated). Returns recall details including product description, reason, and distribution pattern. Related: fda_recall_facility_trace (trace a recall to its manufacturing facility by recall_number), fda_ires_enforcement (iRES recall data with cross-references), fda_device_recalls (device-specific recall data).
読み取り専用
冪等
入力スキーマ
{'type': 'object', '$schema': 'http://json-schema.org/draft-07/schema#', 'properties': {'limit': {'type': 'integer', 'default': 100, 'maximum': 500, 'minimum': 1, 'description': 'Max results to return (1-500)'}, 'offset': {'type': 'integer', 'default': 0, 'maximum': 9007199254740991, 'minimum': 0, 'description': 'Result offset for pagination'}, 'status': {'enum': ['Ongoing', 'Terminated'], 'type': 'string', 'description': 'Recall status'}, 'company': {'type': 'string', 'maxLength': 500, 'description': 'Company or firm name (fuzzy search)'}, 'to_date': {'type': 'string', 'pattern': '^\\d{4}-\\d{2}-\\d{2}$', 'description': 'End date for report_date range (YYYY-MM-DD)'}, 'from_date': {'type': 'string', 'pattern': '^\\d{4}-\\d{2}-\\d{2}$', 'description': 'Start date for report_date range (YYYY-MM-DD)'}, 'classification': {'enum': ['Class I', 'Class II', 'Class III'], 'type': 'string', 'description': 'Recall classification severity'}}}
fda_search_facilities
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., '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).
読み取り専用
冪等
入力スキーマ
{'type': 'object', '$schema': 'http://json-schema.org/draft-07/schema#', 'properties': {'city': {'type': 'string', 'maxLength': 500, 'description': 'City name'}, 'limit': {'type': 'integer', 'default': 100, 'maximum': 500, 'minimum': 1, 'description': 'Max results to return (1-500)'}, 'state': {'type': 'string', 'maxLength': 500, 'description': 'State code (e.g. CA, NY)'}, 'offset': {'type': 'integer', 'default': 0, 'maximum': 9007199254740991, 'minimum': 0, 'description': 'Result offset for pagination'}, 'company': {'type': 'string', 'maxLength': 500, 'description': 'Facility or company name (fuzzy search)'}, 'country': {'type': 'string', 'maxLength': 500, 'description': 'ISO country code (e.g. US, DE)'}, 'operations': {'type': 'string', 'maxLength': 500, 'description': 'DECRS operations keyword'}}}
fda_search_family_facilities
Search Family Facilities
Search FDA-registered facilities across a parent company and any explicitly linked subsidiaries. Use this when you know the parent company but the FDA records may sit under child entities like Actavis, Watson, or Cephalon. Supports optional city, state, country, and operations filters.
読み取り専用
冪等
入力スキーマ
{'type': 'object', '$schema': 'http://json-schema.org/draft-07/schema#', 'required': ['company'], 'properties': {'city': {'type': 'string', 'maxLength': 500, 'description': 'City name'}, 'limit': {'type': 'integer', 'default': 100, 'maximum': 500, 'minimum': 1, 'description': 'Max results to return (1-500)'}, 'state': {'type': 'string', 'maxLength': 500, 'description': 'State code (e.g. CA, NY)'}, 'offset': {'type': 'integer', 'default': 0, 'maximum': 9007199254740991, 'minimum': 0, 'description': 'Result offset for pagination'}, 'company': {'type': 'string', 'maxLength': 500, 'description': 'Parent company name'}, 'country': {'type': 'string', 'maxLength': 500, 'description': 'ISO country code (e.g. US, DE)'}, 'operations': {'type': 'string', 'maxLength': 500, 'description': 'DECRS operations keyword'}}}
fda_search_import_alerts
Search FDA 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 and the specific firms currently listed under each alert.
読み取り専用
冪等
入力スキーマ
{'type': 'object', '$schema': 'http://json-schema.org/draft-07/schema#', 'properties': {'limit': {'type': 'integer', 'default': 100, 'maximum': 500, 'minimum': 1, 'description': 'Max results to return (1-500)'}, 'offset': {'type': 'integer', 'default': 0, 'maximum': 9007199254740991, 'minimum': 0, 'description': 'Result offset for pagination'}, 'country': {'type': 'string', 'maxLength': 200, 'description': 'Country name'}, 'date_to': {'type': 'string', 'pattern': '^\\d{4}-\\d{2}-\\d{2}$', 'description': 'End date for publish-date range (YYYY-MM-DD)'}, 'keyword': {'type': 'string', 'maxLength': 500, 'description': 'Keyword to search in the alert title, reason, charge, or product notes'}, 'date_from': {'type': 'string', 'pattern': '^\\d{4}-\\d{2}-\\d{2}$', 'description': 'Start date for publish-date range (YYYY-MM-DD)'}, 'firm_name': {'type': 'string', 'maxLength': 500, 'description': 'Firm name (fuzzy match)'}, 'list_status': {'enum': ['red', 'green'], 'type': 'string', 'description': 'Whether the firm is on the red list or green list'}, 'alert_number': {'type': 'string', 'maxLength': 50, 'description': 'Import alert number, for example 66-40'}}}
fda_search_ndc
Search NDC Directory
Search the National Drug Code (NDC) directory by labeler company, brand name, product NDC, or application number. Returns labeler name, brand name, generic name, dosage form, route, active ingredients, DEA schedule, listing type, and packaging details. Drug products are not linked by FEI; use this tool with company name to find drugs at a company. Related: fda_search_drugs (application-level data with submissions), fda_drug_labels (full product labeling), fda_search_nsde (NSDE cross-reference).
読み取り専用
冪等
入力スキーマ
{'type': 'object', '$schema': 'http://json-schema.org/draft-07/schema#', 'properties': {'limit': {'type': 'integer', 'default': 100, 'maximum': 500, 'minimum': 1, 'description': 'Max results to return (1-500)'}, 'offset': {'type': 'integer', 'default': 0, 'maximum': 9007199254740991, 'minimum': 0, 'description': 'Result offset for pagination'}, 'company': {'type': 'string', 'maxLength': 500, 'description': 'Labeler company name (fuzzy search)'}, 'brand_name': {'type': 'string', 'maxLength': 500, 'description': 'Brand name'}, 'product_ndc': {'type': 'string', 'maxLength': 500, 'description': 'Product NDC'}, 'application_number': {'type': 'string', 'maxLength': 500, 'description': 'Application number'}}}
fda_search_nsde
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 (NDC directory), fda_search_drugs (Drugs@FDA application data).
読み取り専用
冪等
入力スキーマ
{'type': 'object', '$schema': 'http://json-schema.org/draft-07/schema#', 'properties': {'limit': {'type': 'integer', 'default': 100, 'maximum': 500, 'minimum': 1, 'description': 'Max results to return (1-500)'}, 'offset': {'type': 'integer', 'default': 0, 'maximum': 9007199254740991, 'minimum': 0, 'description': 'Result offset for pagination'}, 'package_ndc': {'type': 'string', 'maxLength': 500, 'description': 'Package NDC (exact match)'}, 'proprietary_name': {'type': 'string', 'maxLength': 500, 'description': 'Brand/proprietary name (fuzzy match)'}, 'application_number': {'type': 'string', 'maxLength': 500, 'description': 'Application number (exact match)'}}}
fda_search_oii_records
Search OII Reading Room Records
Search recent FDA Office of Inspections and Investigations reading-room records by company, FEI, record type, country, establishment type, or publish date. This is official FDA document-index metadata with direct links to the posted records, plus incremental extracted document text when available, useful for finding recent 483-style inspection evidence by account.
読み取り専用
冪等
入力スキーマ
{'type': 'object', '$schema': 'http://json-schema.org/draft-07/schema#', 'properties': {'limit': {'type': 'integer', 'default': 100, 'maximum': 500, 'minimum': 1, 'description': 'Max results to return (1-500)'}, 'state': {'type': 'string', 'maxLength': 200, 'description': 'State name'}, 'offset': {'type': 'integer', 'default': 0, 'maximum': 9007199254740991, 'minimum': 0, 'description': 'Result offset for pagination'}, 'country': {'type': 'string', 'maxLength': 200, 'description': 'Country name'}, 'date_to': {'type': 'string', 'pattern': '^\\d{4}-\\d{2}-\\d{2}$', 'description': 'End date for publish_date range (YYYY-MM-DD)'}, 'keyword': {'type': 'string', 'maxLength': 500, 'description': 'Keyword to search in the FDA-provided excerpt and extracted document text'}, 'date_from': {'type': 'string', 'pattern': '^\\d{4}-\\d{2}-\\d{2}$', 'description': 'Start date for publish_date range (YYYY-MM-DD)'}, 'fei_number': {'type': 'string', 'pattern': '^\\d{1,10}$', 'description': 'FDA Establishment Identifier (FEI number)'}, 'record_type': {'type': 'string', 'maxLength': 200, 'description': 'Record type, for example 483'}, 'company_name': {'type': 'string', 'maxLength': 500, 'description': 'Company name (fuzzy match)'}, 'establishment_type': {'type': 'string', 'maxLength': 500, 'description': 'Establishment type, for example Sterile Drug Manufacturer'}}}
fda_search_opdp_untitled_letters
Search OPDP Untitled Letters
Search official FDA OPDP untitled letters for pharmaceutical promotion and advertising issues. Filter by company, product, issue date, close-out availability, or keyword in the extracted untitled-letter text when available.
読み取り専用
冪等
入力スキーマ
{'type': 'object', '$schema': 'http://json-schema.org/draft-07/schema#', 'properties': {'limit': {'type': 'integer', 'default': 100, 'maximum': 500, 'minimum': 1, 'description': 'Max results to return (1-500)'}, 'offset': {'type': 'integer', 'default': 0, 'maximum': 9007199254740991, 'minimum': 0, 'description': 'Result offset for pagination'}, 'date_to': {'type': 'string', 'pattern': '^\\d{4}-\\d{2}-\\d{2}$', 'description': 'End date for issued_date range (YYYY-MM-DD)'}, 'keyword': {'type': 'string', 'maxLength': 500, 'description': 'Keyword to search in the extracted untitled-letter text'}, 'date_from': {'type': 'string', 'pattern': '^\\d{4}-\\d{2}-\\d{2}$', 'description': 'Start date for issued_date range (YYYY-MM-DD)'}, 'company_name': {'type': 'string', 'maxLength': 500, 'description': 'Company name (fuzzy match)'}, 'has_close_out': {'type': 'boolean', 'description': 'Whether the record has a linked close-out letter'}, 'product_issue': {'type': 'string', 'maxLength': 500, 'description': 'Product or issue text from the OPDP table (partial match)'}}}
fda_search_pma
Search PMA Approvals
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).
読み取り専用
冪等
入力スキーマ
{'type': 'object', '$schema': 'http://json-schema.org/draft-07/schema#', 'properties': {'limit': {'type': 'integer', 'default': 100, 'maximum': 500, 'minimum': 1, 'description': 'Max results to return (1-500)'}, 'offset': {'type': 'integer', 'default': 0, 'maximum': 9007199254740991, 'minimum': 0, 'description': 'Result offset for pagination'}, 'company': {'type': 'string', 'maxLength': 500, 'description': 'Company name (fuzzy search)'}, 'to_date': {'type': 'string', 'pattern': '^\\d{4}-\\d{2}-\\d{2}$', 'description': 'End date for decision_date range (YYYY-MM-DD)'}, 'from_date': {'type': 'string', 'pattern': '^\\d{4}-\\d{2}-\\d{2}$', 'description': 'Start date for decision_date range (YYYY-MM-DD)'}, 'product_code': {'type': 'string', 'pattern': '^[A-Z]{2,3}$', 'maxLength': 5, 'description': 'Device product code'}}}
fda_search_recall_text
Full-Text Search Recalls
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).
読み取り専用
冪等
入力スキーマ
{'type': 'object', '$schema': 'http://json-schema.org/draft-07/schema#', 'required': ['query'], 'properties': {'limit': {'type': 'integer', 'default': 100, 'maximum': 500, 'minimum': 1, 'description': 'Max results to return (1-500)'}, 'query': {'type': 'string', 'maxLength': 500, 'minLength': 1, 'description': "Search terms (e.g. 'salmonella contamination', 'mislabeled dosage')"}, 'offset': {'type': 'integer', 'default': 0, 'maximum': 9007199254740991, 'minimum': 0, 'description': 'Result offset for pagination'}, 'date_to': {'type': 'string', 'pattern': '^\\d{4}-\\d{2}-\\d{2}$', 'description': 'End date for report_date range (YYYY-MM-DD)'}, 'date_from': {'type': 'string', 'pattern': '^\\d{4}-\\d{2}-\\d{2}$', 'description': 'Start date for report_date range (YYYY-MM-DD)'}, 'product_type': {'enum': ['Drugs', 'Devices'], 'type': 'string', 'description': 'Filter by product type'}, 'search_field': {'enum': ['reason', 'product', 'both'], 'type': 'string', 'default': 'both', 'description': 'Which field to search: reason_for_recall, product_description, or both (default: both)'}, 'classification': {'enum': ['Class I', 'Class II', 'Class III'], 'type': 'string', 'description': 'Filter by recall classification severity'}}}
fda_search_warning_letters
Search Warning Letters
Search official FDA warning letters with full-text content from the FDA website. Use keyword search for the actual letter body, or filter by company name, issuing office, subject, MARCS-CMS number, product type, or letter issue date. Adds prospecting filters: status (open|responded|closed, derived from response/closeout dates), letter_category (CGMP-manufacturing | BIMO | listing | OPDP/promotion | 503B/compounding | import â heuristic, derived from issuing_office/subject/product_type), and violation_theme (cgmp_subsystem | data_integrity | validation | bimo | listing | promotion â keyword/FTS-derived over subject+body). Set dedupe=true to collapse near-identical letters sharing a MARCS-CMS case number to one canonical row. Each row exposes derived status and letter_category, plus fei_number for one-hop navigation to fda_citations and fda_inspections. This adds narrative context beyond fda_compliance_actions, which only contains dashboard metadata. NOTE: violation_theme and letter_category are best-effort heuristics over free-text fields; keyword cannot be scoped to a parsed cited-violations sub-section because the corpus only stores subject + full letter body.
読み取り専用
冪等
入力スキーマ
{'type': 'object', '$schema': 'http://json-schema.org/draft-07/schema#', 'properties': {'limit': {'type': 'integer', 'default': 100, 'maximum': 500, 'minimum': 1, 'description': 'Max results to return (1-500)'}, 'dedupe': {'type': 'boolean', 'default': False, 'description': 'Collapse letters sharing a MARCS-CMS case number to one canonical row (recommended for prospecting)'}, 'offset': {'type': 'integer', 'default': 0, 'maximum': 9007199254740991, 'minimum': 0, 'description': 'Result offset for pagination'}, 'status': {'enum': ['open', 'responded', 'closed'], 'type': 'string', 'description': 'Derived status: closed (has closeout date), responded (has response date), or open'}, 'date_to': {'type': 'string', 'pattern': '^\\d{4}-\\d{2}-\\d{2}$', 'description': 'End date for letter_issue_date range (YYYY-MM-DD)'}, 'keyword': {'type': 'string', 'maxLength': 500, 'description': 'Full-text query for the warning letter body and subject'}, 'subject': {'type': 'string', 'maxLength': 500, 'description': 'Subject line text (partial match)'}, 'date_from': {'type': 'string', 'pattern': '^\\d{4}-\\d{2}-\\d{2}$', 'description': 'Start date for letter_issue_date range (YYYY-MM-DD)'}, 'company_name': {'type': 'string', 'maxLength': 500, 'description': 'Company name (fuzzy match)'}, 'product_type': {'type': 'string', 'maxLength': 200, 'description': 'Product type from the letter page (e.g. Drugs, Devices, Food)'}, 'issuing_office': {'type': 'string', 'maxLength': 500, 'description': 'Issuing office or center name (partial match)'}, 'letter_category': {'enum': ['CGMP-manufacturing', 'BIMO', 'listing', 'OPDP/promotion', '503B/compounding', 'import'], 'type': 'string', 'description': 'Heuristic category derived from issuing_office/subject/product_type'}, 'violation_theme': {'enum': ['cgmp_subsystem', 'data_integrity', 'validation', 'bimo', 'listing', 'promotion'], 'type': 'string', 'description': 'Heuristic violation theme derived from subject and letter body text'}, 'marcs_cms_number': {'type': 'string', 'pattern': '^\\d{3,10}$', 'description': 'MARCS-CMS case number shown on the letter page'}}}
fda_substance_lookup
Substance Lookup
Look up FDA substance data by UNII code (exact match) or substance name (fuzzy match). Returns substance name, UNII, substance class, molecular formula, and related details. Use to identify active pharmaceutical ingredients.
読み取り専用
冪等
入力スキーマ
{'type': 'object', '$schema': 'http://json-schema.org/draft-07/schema#', 'properties': {'unii': {'type': 'string', 'maxLength': 20, 'description': 'UNII code (exact match)'}, 'limit': {'type': 'integer', 'default': 100, 'maximum': 500, 'minimum': 1, 'description': 'Max results to return (1-500)'}, 'offset': {'type': 'integer', 'default': 0, 'maximum': 9007199254740991, 'minimum': 0, 'description': 'Result offset for pagination'}, 'substance_name': {'type': 'string', 'maxLength': 500, 'description': 'Substance name (fuzzy match)'}}}
fda_suggest_subsidiaries
Discover Subsidiaries
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).
読み取り専用
外部アクセスあり
冪等
入力スキーマ
{'type': 'object', '$schema': 'http://json-schema.org/draft-07/schema#', 'required': ['company'], 'properties': {'cik': {'type': 'string', 'pattern': '^\\d{1,10}$', 'description': 'SEC CIK (optional, auto-resolved if omitted)'}, 'company': {'type': 'string', 'maxLength': 500, 'description': 'Company name to analyze'}}}
fda_tobacco_problems
Search Tobacco Problem Reports
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.
読み取り専用
冪等
入力スキーマ
{'type': 'object', '$schema': 'http://json-schema.org/draft-07/schema#', 'properties': {'limit': {'type': 'integer', 'default': 100, 'maximum': 500, 'minimum': 1, 'description': 'Max results to return (1-500)'}, 'offset': {'type': 'integer', 'default': 0, 'maximum': 9007199254740991, 'minimum': 0, 'description': 'Result offset for pagination'}, 'date_to': {'type': 'string', 'pattern': '^\\d{8}$', 'description': 'End date_submitted (YYYYMMDD)'}, 'date_from': {'type': 'string', 'pattern': '^\\d{8}$', 'description': 'Start date_submitted (YYYYMMDD)'}, 'product_type': {'type': 'string', 'maxLength': 500, 'description': 'Tobacco product type (searches tobacco_products array)'}, 'health_problem': {'type': 'string', 'maxLength': 500, 'description': 'Reported health problem keyword'}}}
fda_vet_events
Search Veterinary Adverse Events
Search veterinary adverse events (animal drug safety reports) by species, drug name, reaction, serious flag, or date range (YYYYMMDD format). Returns event reports including animal details, drug information, and adverse reactions. Related: fda_search_aphis (veterinary biologics facilities and establishments).
読み取り専用
冪等
入力スキーマ
{'type': 'object', '$schema': 'http://json-schema.org/draft-07/schema#', 'properties': {'limit': {'type': 'integer', 'default': 100, 'maximum': 500, 'minimum': 1, 'description': 'Max results to return (1-500)'}, 'offset': {'type': 'integer', 'default': 0, 'maximum': 9007199254740991, 'minimum': 0, 'description': 'Result offset for pagination'}, 'date_to': {'type': 'string', 'pattern': '^\\d{8}$', 'description': 'End receive_date (YYYYMMDD)'}, 'serious': {'enum': ['true', 'false'], 'type': 'string', 'description': 'Filter by serious adverse event'}, 'species': {'type': 'string', 'maxLength': 500, 'description': 'Animal species (searches animal JSONB)'}, 'date_from': {'type': 'string', 'pattern': '^\\d{8}$', 'description': 'Start receive_date (YYYYMMDD)'}, 'drug_name': {'type': 'string', 'maxLength': 500, 'description': 'Drug name (searches drug JSONB)'}}}
履歴
最近のツール変更
追加
fda_device_udi_lookup
2026年9月17日12:45
追加
fda_device_udi
2026年9月17日12:45
追加
fda_drug_labels
2026年9月17日12:45
追加
fda_clinical_result_letters
2026年9月17日12:45
追加
fda_search_nsde
2026年9月17日12:45
追加
fda_substance_lookup
2026年9月17日12:45
追加
fda_tobacco_problems
2026年9月17日12:45
追加
fda_vet_events
2026年9月17日12:45
追加
fda_consumer_events
2026年9月17日12:45
追加
fda_device_recalls
2026年9月17日12:45
追加
fda_drug_shortages
2026年9月17日12:45
追加
fda_ires_enforcement
2026年9月17日12:45
追加
fda_import_refusals
2026年9月17日12:45
追加
fda_inspection_observation_summary
2026年9月17日12:45
追加
fda_device_supply_status
2026年9月17日12:45
追加
fda_bpdr_summary
2026年9月17日12:45
追加
fda_search_import_alerts
2026年9月17日12:45
追加
fda_search_debarments
2026年9月17日12:45
追加
fda_search_oii_records
2026年9月17日12:45
追加
fda_search_opdp_untitled_letters
2026年9月17日12:45
追加
fda_search_warning_letters
2026年9月17日12:45
追加
fda_compliance_actions
2026年9月17日12:45
追加
fda_citations
2026年9月17日12:45
追加
fda_inspections
2026年9月17日12:45
追加
fda_company_full
2026年9月17日12:45
追加
fda_recall_facility_trace
2026年9月17日12:45
追加
fda_search_by_product
2026年9月17日12:45
追加
fda_search_ndc
2026年9月17日12:45
追加
fda_search_drugs
2026年9月17日12:45
追加
fda_product_code_lookup
2026年9月17日12:45
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