{ "openapi": "3.1.0", "info": { "title": "FDA Intel API", "version": "v1", "summary": "FDA inspection data: Form 483s, EIRs, warning letters, investigators, 21 CFR citations, plus FDA public data.", "description": "Read-only REST API over the FDA Intel catalog of FDA inspection documents and FDA public data. The same tools are available to AI assistants through the MCP server at https://fdaintel.ai/mcp.\n\nOne request is one tool call in Claude or ChatGPT, or one API call. Usage resets every month. Standard: 10,000 requests a month (up to 1,000 a day). Premium: 50,000 requests a month (up to 5,000 a day). A top-up adds 10,000 requests for $29, one time. Unused top-up requests end with the current monthly allowance period.\n\nFull reference: https://fdaintel.ai/api/docs", "contact": { "name": "FDA Intel", "url": "https://fdaintel.ai/contact" }, "termsOfService": "https://fdaintel.ai/legal/terms" }, "externalDocs": { "description": "API reference", "url": "https://fdaintel.ai/api/docs" }, "servers": [ { "url": "https://fdaintel.ai" } ], "security": [ { "apiKey": [] }, { "oauth2": [ "intel:read" ] } ], "tags": [ { "name": "Inspection documents", "description": "Form 483s, EIRs, warning letters, responses and close-out letters in the FDA Intel catalog: search, metadata, summaries and observation previews, with each document's link on FDA Intel." }, { "name": "Firms and investigators", "description": "Site profiles by firm id or FEI, and FDA investigator profiles with what each one cites most." }, { "name": "Regulations and catalog", "description": "21 CFR sections with how often FDA cites them, filter values and catalog totals." }, { "name": "FDA public data", "description": "Inspections and citations, warning-letter status, import alerts, recalls, drug shortages, registrations, 510(k), PMA, NDC, drug applications and debarment." } ], "paths": { "/api/intel/v1/call/search": { "get": { "operationId": "search", "summary": "Search FDA Intel documents", "description": "Search the FDA Intel catalog of FDA inspection documents (Form 483s, EIRs, warning letters, responses, close-out letters) by keyword, firm, FEI, investigator, regulation or topic. Returns up to 20 matches as {results:[{id,title,url,text}]}; pass an id to fetch for the document. For filters and paging use search_documents.\n\nSame as the MCP tool `search`.", "tags": [ "Inspection documents" ], "parameters": [ { "name": "query", "in": "query", "required": true, "description": "What to look for, e.g. 'Sun Pharma Halol data integrity' or 'aseptic processing 211.113'.", "schema": { "type": "string" } } ], "responses": { "200": { "description": "Success", "headers": { "X-RateLimit-Remaining": { "$ref": "#/components/headers/RateRemaining" }, "X-RateLimit-Limit": { "$ref": "#/components/headers/RateLimit" }, "X-RateLimit-Reset": { "$ref": "#/components/headers/RateReset" } }, "content": { "application/json": { "schema": { "type": "object" }, "example": { "results": [ { "id": "ex4mpl3d0c01", "title": "Form 483 · Example Pharma Ltd. · Hyderabad, Telangana, India · 2025-03-14", "url": "https://fdaintel.ai/d/ex4mpl3d0c01", "text": "Laboratory records were incomplete and out-of-specification results were not investigated." } ] } } } }, "400": { "$ref": "#/components/responses/E400" }, "401": { "$ref": "#/components/responses/E401" }, "403": { "$ref": "#/components/responses/E403" }, "404": { "$ref": "#/components/responses/E404" }, "429": { "$ref": "#/components/responses/E429" } } } }, "/api/intel/v1/call/fetch": { "get": { "operationId": "fetch", "summary": "Fetch a document", "description": "Fetch one FDA Intel document by id: its summary, observation previews and every metadata field. The full document is not included; the \"document\" field gives its type, date, observations, pages, price_usd and link on FDA Intel.\n\nSame as the MCP tool `fetch`.", "tags": [ "Inspection documents" ], "parameters": [ { "name": "id", "in": "query", "required": true, "description": "Document id from search.", "schema": { "type": "string" } } ], "responses": { "200": { "description": "Success", "headers": { "X-RateLimit-Remaining": { "$ref": "#/components/headers/RateRemaining" }, "X-RateLimit-Limit": { "$ref": "#/components/headers/RateLimit" }, "X-RateLimit-Reset": { "$ref": "#/components/headers/RateReset" } }, "content": { "application/json": { "schema": { "type": "object" }, "example": { "id": "ex4mpl3d0c01", "title": "Form 483 · Example Pharma Ltd. · Hyderabad, Telangana, India · 2025-03-14", "text": "Laboratory records were incomplete and out-of-specification results were not investigated.", "url": "https://fdaintel.ai/d/ex4mpl3d0c01", "metadata": { "id": "ex4mpl3d0c01", "doc_type": "483", "label": null, "title": "Form 483 · Example Pharma Ltd. · 2025-03-14", "firm_name": "Example Pharma Ltd.", "firm_name_on_document": "Example Pharma Ltd.", "firm_id": "3001234567", "fei": "3001234567", "street": "1 Example Road", "city": "Hyderabad", "state": "Telangana", "zip": "500001", "country": "India", "document_date": "2025-03-14", "issue_date": "2025-03-14", "inspection_start": "2025-03-03", "inspection_end": "2025-03-14", "date_estimated": false, "center_program": "Drugs (CDER)", "establishment_type": "Manufacturer", "page_count": 9, "observation_count": 6, "investigator_names": "Jane Example", "summary": "Laboratory records were incomplete and out-of-specification results were not investigated.", "marcs_cms": null, "available": true, "has_text": true, "price_cents": 9900, "url": "https://fdaintel.ai/d/ex4mpl3d0c01", "owned": false, "observations": [ { "ordinal": 1, "preview": "Laboratory controls do not include the establishment of scientifically sound…", "cfr": [ { "cite": "21 CFR 211.160", "section": "211.160", "heading": "General requirements", "inferred": false } ], "system_area": "drug:laboratory", "topics": [ "lab_controls", "data_integrity" ], "repeat": true, "severity": 3 } ], "document": { "type": "Form 483", "date": "2025-03-14", "observations": 6, "pages": 9, "price_usd": 99, "link": "https://fdaintel.ai/d/ex4mpl3d0c01", "owned": false, "available_to_buy": true }, "full_text": "not_included" } } } } }, "400": { "$ref": "#/components/responses/E400" }, "401": { "$ref": "#/components/responses/E401" }, "403": { "$ref": "#/components/responses/E403" }, "404": { "$ref": "#/components/responses/E404" }, "429": { "$ref": "#/components/responses/E429" } } } }, "/api/intel/v1/documents": { "get": { "operationId": "search_documents", "summary": "Search documents with filters", "description": "Search documents with every available filter (keyword, type, firm, FEI, investigator, place, date range, CFR section, observation text, product type, classification, topic, sector …). Returns total, a page of documents with all list fields (summary included) and next_offset.\n\nAlso callable as /api/intel/v1/call/search_documents.\n\nSame as the MCP tool `search_documents`.", "tags": [ "Inspection documents" ], "parameters": [ { "name": "q", "in": "query", "required": false, "description": "Keyword full-text search over the whole document text, title, firm and investigators. Supports \"quoted phrases\", OR, and -exclusions. Also matches an exact FEI, document id or MARCS-CMS number.", "schema": { "type": "string" } }, { "name": "doc_type", "in": "query", "required": false, "description": "Document types: 483 (Form FDA 483), 483_amended, eir (Establishment Inspection Report), 483_response, warning_letter, wl_response, untitled_letter (FDA enforcement letter below warning-letter level), untitled_letter_response, close_out_letter, import_alert, fda_correspondence, other.", "schema": { "type": "array", "items": { "type": "string", "enum": [ "483", "483_amended", "eir", "483_response", "warning_letter", "wl_response", "untitled_letter", "untitled_letter_response", "close_out_letter", "import_alert", "fda_correspondence", "other" ] } }, "style": "form", "explode": false }, { "name": "firm", "in": "query", "required": false, "description": "Firm / site name contains (case-insensitive; also matches known aliases).", "schema": { "type": "string" } }, { "name": "firm_id", "in": "query", "required": false, "description": "Exact firm id (slug from search_firms) or numeric firm id.", "schema": { "type": "string" } }, { "name": "fei", "in": "query", "required": false, "description": "Exact FDA Establishment Identifier (FEI) of the inspected site.", "schema": { "type": "string" } }, { "name": "investigator", "in": "query", "required": false, "description": "Investigator name contains (case-insensitive, any name variant).", "schema": { "type": "string" } }, { "name": "investigator_id", "in": "query", "required": false, "description": "Exact investigator id (slug from search_investigators).", "schema": { "type": "string" } }, { "name": "city", "in": "query", "required": false, "description": "City (exact, case-insensitive).", "schema": { "type": "string" } }, { "name": "state", "in": "query", "required": false, "description": "US state or province code/name (exact, case-insensitive), e.g. NJ.", "schema": { "type": "string" } }, { "name": "country", "in": "query", "required": false, "description": "Country (exact, case-insensitive), e.g. India. 'US'/'USA'/'United States' all match the United States.", "schema": { "type": "string" } }, { "name": "date_from", "in": "query", "required": false, "description": "Earliest date, inclusive: 2023, 2023-06 or 2023-06-15.", "schema": { "type": "string" } }, { "name": "date_to", "in": "query", "required": false, "description": "Latest date, inclusive: 2024, 2024-03 or 2024-03-31.", "schema": { "type": "string" } }, { "name": "date_field", "in": "query", "required": false, "description": "Which date the range applies to: document (default: issue date, else inspection end/start), issue, inspection_start, inspection_end.", "schema": { "type": "string", "enum": [ "document", "issue", "inspection_start", "inspection_end" ] } }, { "name": "cfr", "in": "query", "required": false, "description": "Cited regulation: a 21 CFR section (211.192) or a whole part (211, 820). Matches 483 observations and warning-letter violations.", "schema": { "type": "string" } }, { "name": "observation", "in": "query", "required": false, "description": "Full-text search within 483 observation statements and warning-letter violation headings only.", "schema": { "type": "string" } }, { "name": "center", "in": "query", "required": false, "description": "FDA center / program contains, e.g. CDER, CDRH, Biologics, Foods, Tobacco, compounding.", "schema": { "type": "string" } }, { "name": "establishment_type", "in": "query", "required": false, "description": "Establishment type contains, e.g. 'Manufacturer', 'Outsourcing Facility'.", "schema": { "type": "string" } }, { "name": "product_type", "in": "query", "required": false, "description": "Product type contains (from FDA inspection data and warning letters): Drugs, Devices, Biologics, Food/Cosmetics, Veterinary, Tobacco …", "schema": { "type": "string" } }, { "name": "sector", "in": "query", "required": false, "description": "Establishment sector: drugs, devices, food, blood_biologics, vet, tobacco, bimo.", "schema": { "type": "string" } }, { "name": "inspecting_agency", "in": "query", "required": false, "description": "fda, state_under_fda_contract or state_local.", "schema": { "type": "string" } }, { "name": "classification", "in": "query", "required": false, "description": "FDA inspection classification of the matched inspection.", "schema": { "type": "array", "items": { "type": "string", "enum": [ "NAI", "VAI", "OAI" ] } }, "style": "form", "explode": false }, { "name": "system_area", "in": "query", "required": false, "description": "Quality system area of an observation/violation contains, e.g. drug:laboratory, device:capa (see list_facets).", "schema": { "type": "string" } }, { "name": "topic", "in": "query", "required": false, "description": "Observation topic, e.g. aseptic_sterility, data_integrity, cleaning_validation (exact; see list_facets).", "schema": { "type": "string" } }, { "name": "repeat", "in": "query", "required": false, "description": "Only documents with an explicit repeat observation / repeat violation.", "schema": { "type": "boolean" } }, { "name": "issuing_office", "in": "query", "required": false, "description": "Warning letters: issuing office contains.", "schema": { "type": "string" } }, { "name": "marcs_cms", "in": "query", "required": false, "description": "Exact MARCS-CMS case number (warning letters, close-outs).", "schema": { "type": "string" } }, { "name": "has_summary", "in": "query", "required": false, "description": "Only documents with (true) or without (false) a written summary.", "schema": { "type": "boolean" } }, { "name": "has_text", "in": "query", "required": false, "description": "Only documents with (true) or without (false) extracted text.", "schema": { "type": "boolean" } }, { "name": "has_observations", "in": "query", "required": false, "description": "Only documents with (true) or without (false) extracted observations.", "schema": { "type": "boolean" } }, { "name": "available", "in": "query", "required": false, "description": "Only documents that are (true) or are not (false) available to buy as a PDF.", "schema": { "type": "boolean" } }, { "name": "min_observations", "in": "query", "required": false, "description": "At least this many observations.", "schema": { "type": "integer", "minimum": 0 } }, { "name": "min_pages", "in": "query", "required": false, "description": "At least this many pages.", "schema": { "type": "integer", "minimum": 0 } }, { "name": "sort", "in": "query", "required": false, "description": "relevance (default with q), date_desc (default otherwise), date_asc, firm, observations, added_desc.", "schema": { "type": "string", "enum": [ "relevance", "date_desc", "date_asc", "firm", "observations", "added_desc" ] } }, { "name": "limit", "in": "query", "required": false, "description": "Results per page (default 25, max 100).", "schema": { "type": "integer", "minimum": 1, "maximum": 100 } }, { "name": "offset", "in": "query", "required": false, "description": "Skip this many results (use next_offset from the previous page).", "schema": { "type": "integer", "minimum": 0 } } ], "responses": { "200": { "description": "Success", "headers": { "X-RateLimit-Remaining": { "$ref": "#/components/headers/RateRemaining" }, "X-RateLimit-Limit": { "$ref": "#/components/headers/RateLimit" }, "X-RateLimit-Reset": { "$ref": "#/components/headers/RateReset" } }, "content": { "application/json": { "schema": { "type": "object" }, "example": { "total": 12, "offset": 0, "limit": 10, "returned": 1, "next_offset": 1, "results": [ { "id": "ex4mpl3d0c01", "doc_type": "483", "label": null, "title": "Form 483 · Example Pharma Ltd. · 2025-03-14", "firm_name": "Example Pharma Ltd.", "firm_name_on_document": "Example Pharma Ltd.", "firm_id": "3001234567", "fei": "3001234567", "street": "1 Example Road", "city": "Hyderabad", "state": "Telangana", "zip": "500001", "country": "India", "document_date": "2025-03-14", "issue_date": "2025-03-14", "inspection_start": "2025-03-03", "inspection_end": "2025-03-14", "date_estimated": false, "center_program": "Drugs (CDER)", "establishment_type": "Manufacturer", "page_count": 9, "observation_count": 6, "investigator_names": "Jane Example", "summary": "Laboratory records were incomplete and out-of-specification results were not investigated.", "marcs_cms": null, "available": true, "has_text": true, "price_cents": 9900, "url": "https://fdaintel.ai/d/ex4mpl3d0c01", "owned": false } ], "sort": "date_desc" } } } }, "400": { "$ref": "#/components/responses/E400" }, "401": { "$ref": "#/components/responses/E401" }, "403": { "$ref": "#/components/responses/E403" }, "404": { "$ref": "#/components/responses/E404" }, "429": { "$ref": "#/components/responses/E429" } } } }, "/api/intel/v1/documents/{id}": { "get": { "operationId": "get_document", "summary": "Get everything about a document", "description": "Everything about one document: metadata, summary, investigators (with career stats), each 483 observation's opening words with its CFR citations, system area and topics, inspection classification, warning-letter data (violations with CFR citations and response verdicts, linked 483s/EIRs, close-out), follow-on actions and other documents for the same site. The full document is not included; the \"document\" field gives its type, date, observations, pages, price_usd and link on FDA Intel.\n\nAlso callable as /api/intel/v1/call/get_document.\n\nSame as the MCP tool `get_document`.", "tags": [ "Inspection documents" ], "parameters": [ { "name": "id", "in": "path", "required": true, "description": "Document id (the public id, e.g. 'dfjgwg9kdht2', as returned by search).", "schema": { "type": "string" } } ], "responses": { "200": { "description": "Success", "headers": { "X-RateLimit-Remaining": { "$ref": "#/components/headers/RateRemaining" }, "X-RateLimit-Limit": { "$ref": "#/components/headers/RateLimit" }, "X-RateLimit-Reset": { "$ref": "#/components/headers/RateReset" } }, "content": { "application/json": { "schema": { "type": "object" }, "example": { "id": "ex4mpl3d0c01", "doc_type": "483", "label": null, "title": "Form 483 · Example Pharma Ltd. · 2025-03-14", "firm_name": "Example Pharma Ltd.", "firm_name_on_document": "Example Pharma Ltd.", "firm_id": "3001234567", "fei": "3001234567", "street": "1 Example Road", "city": "Hyderabad", "state": "Telangana", "zip": "500001", "country": "India", "document_date": "2025-03-14", "issue_date": "2025-03-14", "inspection_start": "2025-03-03", "inspection_end": "2025-03-14", "date_estimated": false, "center_program": "Drugs (CDER)", "establishment_type": "Manufacturer", "page_count": 9, "observation_count": 6, "investigator_names": "Jane Example", "summary": "Laboratory records were incomplete and out-of-specification results were not investigated.", "marcs_cms": null, "available": true, "has_text": true, "price_cents": 9900, "url": "https://fdaintel.ai/d/ex4mpl3d0c01", "owned": false, "investigators": [ { "id": "jane-example", "name": "Jane Example", "name_variants": [] } ], "observations": [ { "ordinal": 1, "preview": "Laboratory controls do not include the establishment of scientifically sound…", "cfr": [ { "cite": "21 CFR 211.160", "section": "211.160", "heading": "General requirements", "inferred": false } ], "system_area": "drug:laboratory", "topics": [ "lab_controls", "data_integrity" ], "repeat": true, "severity": 3 } ], "inspection": { "fei": "3001234567", "inspection_start": "2025-03-03", "inspection_end": "2025-03-14", "duration_days": 12, "classification": "OAI" }, "warning_letter": null, "same_site_documents": [ { "id": "ex4mpl3d0c02", "doc_type": "warning_letter", "document_date": "2025-09-30", "url": "https://fdaintel.ai/d/ex4mpl3d0c02" } ], "document": { "type": "Form 483", "date": "2025-03-14", "observations": 6, "pages": 9, "price_usd": 99, "link": "https://fdaintel.ai/d/ex4mpl3d0c01", "owned": false, "available_to_buy": true }, "full_text": "not_included" } } } }, "400": { "$ref": "#/components/responses/E400" }, "401": { "$ref": "#/components/responses/E401" }, "403": { "$ref": "#/components/responses/E403" }, "404": { "$ref": "#/components/responses/E404" }, "429": { "$ref": "#/components/responses/E429" } } } }, "/api/intel/v1/observations": { "get": { "operationId": "search_observations", "summary": "Search observations and violations", "description": "Search individual 483 observations and warning-letter violations by words, CFR section, system area, topic or repeat flag, with the same document filters as search_documents (firm, FEI, investigator, dates, type, place …). Each hit has the statement's opening words, CFR citations, area, topics and its document.\n\nAlso callable as /api/intel/v1/call/search_observations.\n\nSame as the MCP tool `search_observations`.", "tags": [ "Inspection documents" ], "parameters": [ { "name": "q", "in": "query", "required": false, "description": "Full-text search in observation statements / violation headings.", "schema": { "type": "string" } }, { "name": "kind", "in": "query", "required": false, "description": "all (default), 483 or warning_letter.", "schema": { "type": "string", "enum": [ "all", "483", "warning_letter" ] } }, { "name": "cfr", "in": "query", "required": false, "description": "Cited regulation: a 21 CFR section (211.192) or a whole part (211, 820). Matches 483 observations and warning-letter violations.", "schema": { "type": "string" } }, { "name": "system_area", "in": "query", "required": false, "description": "Quality system area of an observation/violation contains, e.g. drug:laboratory, device:capa (see list_facets).", "schema": { "type": "string" } }, { "name": "topic", "in": "query", "required": false, "description": "Observation topic, e.g. aseptic_sterility, data_integrity, cleaning_validation (exact; see list_facets).", "schema": { "type": "string" } }, { "name": "repeat", "in": "query", "required": false, "description": "Only repeat observations / violations.", "schema": { "type": "boolean" } }, { "name": "firm", "in": "query", "required": false, "description": "Firm / site name contains (case-insensitive; also matches known aliases).", "schema": { "type": "string" } }, { "name": "firm_id", "in": "query", "required": false, "description": "Exact firm id (slug from search_firms) or numeric firm id.", "schema": { "type": "string" } }, { "name": "fei", "in": "query", "required": false, "description": "Exact FDA Establishment Identifier (FEI) of the inspected site.", "schema": { "type": "string" } }, { "name": "investigator", "in": "query", "required": false, "description": "Investigator name contains (case-insensitive, any name variant).", "schema": { "type": "string" } }, { "name": "investigator_id", "in": "query", "required": false, "description": "Exact investigator id (slug from search_investigators).", "schema": { "type": "string" } }, { "name": "doc_type", "in": "query", "required": false, "description": "Document types: 483 (Form FDA 483), 483_amended, eir (Establishment Inspection Report), 483_response, warning_letter, wl_response, untitled_letter (FDA enforcement letter below warning-letter level), untitled_letter_response, close_out_letter, import_alert, fda_correspondence, other.", "schema": { "type": "array", "items": { "type": "string", "enum": [ "483", "483_amended", "eir", "483_response", "warning_letter", "wl_response", "untitled_letter", "untitled_letter_response", "close_out_letter", "import_alert", "fda_correspondence", "other" ] } }, "style": "form", "explode": false }, { "name": "country", "in": "query", "required": false, "description": "Country (exact, case-insensitive), e.g. India. 'US'/'USA'/'United States' all match the United States.", "schema": { "type": "string" } }, { "name": "state", "in": "query", "required": false, "description": "US state or province code/name (exact, case-insensitive), e.g. NJ.", "schema": { "type": "string" } }, { "name": "date_from", "in": "query", "required": false, "description": "Earliest date, inclusive: 2023, 2023-06 or 2023-06-15.", "schema": { "type": "string" } }, { "name": "date_to", "in": "query", "required": false, "description": "Latest date, inclusive: 2024, 2024-03 or 2024-03-31.", "schema": { "type": "string" } }, { "name": "center", "in": "query", "required": false, "description": "FDA center / program contains, e.g. CDER, CDRH, Biologics, Foods, Tobacco, compounding.", "schema": { "type": "string" } }, { "name": "product_type", "in": "query", "required": false, "description": "Product type contains (from FDA inspection data and warning letters): Drugs, Devices, Biologics, Food/Cosmetics, Veterinary, Tobacco …", "schema": { "type": "string" } }, { "name": "limit", "in": "query", "required": false, "description": "Results per page (default 25, max 100).", "schema": { "type": "integer", "minimum": 1, "maximum": 100 } }, { "name": "offset", "in": "query", "required": false, "description": "Skip this many results (use next_offset from the previous page).", "schema": { "type": "integer", "minimum": 0 } } ], "responses": { "200": { "description": "Success", "headers": { "X-RateLimit-Remaining": { "$ref": "#/components/headers/RateRemaining" }, "X-RateLimit-Limit": { "$ref": "#/components/headers/RateLimit" }, "X-RateLimit-Reset": { "$ref": "#/components/headers/RateReset" } }, "content": { "application/json": { "schema": { "type": "object" }, "example": { "total": 140, "offset": 0, "limit": 10, "returned": 1, "next_offset": 1, "results": [ { "kind": "483_observation", "document_id": "ex4mpl3d0c01", "doc_type": "483", "firm_name": "Example Pharma Ltd.", "firm_id": "3001234567", "fei": "3001234567", "country": "India", "document_date": "2025-03-14", "ordinal": 2, "cfr": [ "211.192" ], "system_area": "drug:quality", "topics": [ "investigations" ], "repeat": false, "severity": 3, "url": "https://fdaintel.ai/d/ex4mpl3d0c01", "preview": "There is a failure to thoroughly review any unexplained discrepancy…", "owned": false } ] } } } }, "400": { "$ref": "#/components/responses/E400" }, "401": { "$ref": "#/components/responses/E401" }, "403": { "$ref": "#/components/responses/E403" }, "404": { "$ref": "#/components/responses/E404" }, "429": { "$ref": "#/components/responses/E429" } } } }, "/api/intel/v1/firms": { "get": { "operationId": "search_firms", "summary": "Search firms and sites", "description": "Find firms / inspected sites in the FDA Intel catalog by name, alias, FEI or place. A name query matches firms whose name contains every word (exact and prefix matches first); only if none do does it fall back to a short list of similar names (match: fuzzy). Returns firm ids, FEI, location, document counts and last document date.\n\nAlso callable as /api/intel/v1/call/search_firms.\n\nSame as the MCP tool `search_firms`.", "tags": [ "Firms and investigators" ], "parameters": [ { "name": "q", "in": "query", "required": false, "description": "Firm name, alias, FEI or slug.", "schema": { "type": "string" } }, { "name": "fei", "in": "query", "required": false, "description": "Exact FEI.", "schema": { "type": "string" } }, { "name": "city", "in": "query", "required": false, "description": "City.", "schema": { "type": "string" } }, { "name": "state", "in": "query", "required": false, "description": "State.", "schema": { "type": "string" } }, { "name": "country", "in": "query", "required": false, "description": "Country.", "schema": { "type": "string" } }, { "name": "limit", "in": "query", "required": false, "description": "Results per page (default 25, max 100).", "schema": { "type": "integer", "minimum": 1, "maximum": 100 } }, { "name": "offset", "in": "query", "required": false, "description": "Skip this many results (use next_offset from the previous page).", "schema": { "type": "integer", "minimum": 0 } } ], "responses": { "200": { "description": "Success", "headers": { "X-RateLimit-Remaining": { "$ref": "#/components/headers/RateRemaining" }, "X-RateLimit-Limit": { "$ref": "#/components/headers/RateLimit" }, "X-RateLimit-Reset": { "$ref": "#/components/headers/RateReset" } }, "content": { "application/json": { "schema": { "type": "object" }, "example": { "total": 1, "offset": 0, "limit": 25, "returned": 1, "next_offset": null, "results": [ { "id": "3001234567", "name": "Example Pharma Ltd.", "aliases": [ "Example Pharma Unit II" ], "fei": "3001234567", "city": "Hyderabad", "state": "Telangana", "country": "India", "establishment_type": "Manufacturer", "documents": 5, "last_document_date": "2025-09-30", "types": [ "483", "warning_letter" ], "url": "https://fdaintel.ai/firm/3001234567" } ], "match": "all_words" } } } }, "400": { "$ref": "#/components/responses/E400" }, "401": { "$ref": "#/components/responses/E401" }, "403": { "$ref": "#/components/responses/E403" }, "404": { "$ref": "#/components/responses/E404" }, "429": { "$ref": "#/components/responses/E429" } } } }, "/api/intel/v1/firms/{id}": { "get": { "operationId": "get_firm", "summary": "Firm / site profile", "description": "Full profile of a firm or site (by firm id, numeric id or FEI): all its documents (paged), investigators who inspected it, most-cited CFR sections, observation topics and system areas, inspection classifications, warning letters, and FDA public history for the FEI (inspections, compliance actions, recalls, import refusals, import alerts). Use for pre-inspection briefs.\n\nAlso callable as /api/intel/v1/call/get_firm.\n\nSame as the MCP tool `get_firm`.", "tags": [ "Firms and investigators" ], "parameters": [ { "name": "id", "in": "path", "required": true, "description": "Firm id (slug), numeric firm id, or FEI.", "schema": { "type": "string" } }, { "name": "limit", "in": "query", "required": false, "description": "Documents per page (default 100, max 500).", "schema": { "type": "integer", "minimum": 1, "maximum": 500 } }, { "name": "offset", "in": "query", "required": false, "description": "Skip this many results (use next_offset from the previous page).", "schema": { "type": "integer", "minimum": 0 } } ], "responses": { "200": { "description": "Success", "headers": { "X-RateLimit-Remaining": { "$ref": "#/components/headers/RateRemaining" }, "X-RateLimit-Limit": { "$ref": "#/components/headers/RateLimit" }, "X-RateLimit-Reset": { "$ref": "#/components/headers/RateReset" } }, "content": { "application/json": { "schema": { "type": "object" }, "example": { "firm": { "id": "3001234567", "name": "Example Pharma Ltd.", "aliases": [], "fei": "3001234567", "city": "Hyderabad", "state": "Telangana", "country": "India", "establishment_type": "Manufacturer", "url": "https://fdaintel.ai/firm/3001234567" }, "documents": { "total": 5, "offset": 0, "limit": 25, "returned": 1, "next_offset": 1, "results": [ { "id": "ex4mpl3d0c01", "doc_type": "483", "label": null, "title": "Form 483 · Example Pharma Ltd. · 2025-03-14", "firm_name": "Example Pharma Ltd.", "firm_name_on_document": "Example Pharma Ltd.", "firm_id": "3001234567", "fei": "3001234567", "street": "1 Example Road", "city": "Hyderabad", "state": "Telangana", "zip": "500001", "country": "India", "document_date": "2025-03-14", "issue_date": "2025-03-14", "inspection_start": "2025-03-03", "inspection_end": "2025-03-14", "date_estimated": false, "center_program": "Drugs (CDER)", "establishment_type": "Manufacturer", "page_count": 9, "observation_count": 6, "investigator_names": "Jane Example", "summary": "Laboratory records were incomplete and out-of-specification results were not investigated.", "marcs_cms": null, "available": true, "has_text": true, "price_cents": 9900, "url": "https://fdaintel.ai/d/ex4mpl3d0c01", "owned": false } ] }, "investigators": [ { "id": "jane-example", "name": "Jane Example", "documents": 2 } ], "top_cfr_sections": [ { "section": "211.160", "heading": "General requirements", "documents": 2, "citations": 3 } ], "top_topics": [ { "topic": "lab_controls", "observations": 4 } ], "inspection_classifications": [ { "classification": "OAI", "n": 1 }, { "classification": "VAI", "n": 2 } ], "warning_letters": [ { "document_id": "ex4mpl3d0c02", "letter_date": "2025-09-30", "subject": "CGMP/Finished Pharmaceuticals/Adulterated", "violation_count": 3, "closeout_date": null } ], "fda_history": { "summary": { "fda_inspections": 4, "oai_inspections": 1, "warning_letters": 1, "recalled_products": 0, "import_refusals": 2 } } } } } }, "400": { "$ref": "#/components/responses/E400" }, "401": { "$ref": "#/components/responses/E401" }, "403": { "$ref": "#/components/responses/E403" }, "404": { "$ref": "#/components/responses/E404" }, "429": { "$ref": "#/components/responses/E429" } } } }, "/api/intel/v1/investigators": { "get": { "operationId": "search_investigators", "summary": "Search FDA investigators", "description": "Find FDA investigators by name (fuzzy, any variant). Returns ids, document and site counts, first/last seen.\n\nAlso callable as /api/intel/v1/call/search_investigators.\n\nSame as the MCP tool `search_investigators`.", "tags": [ "Firms and investigators" ], "parameters": [ { "name": "q", "in": "query", "required": false, "description": "Investigator name or part of it.", "schema": { "type": "string" } }, { "name": "limit", "in": "query", "required": false, "description": "Results per page (default 25, max 100).", "schema": { "type": "integer", "minimum": 1, "maximum": 100 } }, { "name": "offset", "in": "query", "required": false, "description": "Skip this many results (use next_offset from the previous page).", "schema": { "type": "integer", "minimum": 0 } } ], "responses": { "200": { "description": "Success", "headers": { "X-RateLimit-Remaining": { "$ref": "#/components/headers/RateRemaining" }, "X-RateLimit-Limit": { "$ref": "#/components/headers/RateLimit" }, "X-RateLimit-Reset": { "$ref": "#/components/headers/RateReset" } }, "content": { "application/json": { "schema": { "type": "object" }, "example": { "total": 1, "offset": 0, "limit": 25, "returned": 1, "next_offset": null, "results": [ { "id": "jane-example", "name": "Jane Example", "name_variants": [ "J. Example" ], "documents": 48, "sites": 41, "first": "2016-02-09", "last": "2025-03-14", "form_483s": 44, "eirs": 4, "oai_inspections": 9, "classified_inspections": 40, "url": "https://fdaintel.ai/investigator/jane-example" } ] } } } }, "400": { "$ref": "#/components/responses/E400" }, "401": { "$ref": "#/components/responses/E401" }, "403": { "$ref": "#/components/responses/E403" }, "404": { "$ref": "#/components/responses/E404" }, "429": { "$ref": "#/components/responses/E429" } } } }, "/api/intel/v1/investigators/{id}": { "get": { "operationId": "get_investigator", "summary": "Investigator profile", "description": "Full profile of an FDA investigator: stats (483s, EIRs, average observations, inspection length, OAI share), every document (paged), sites inspected, co-investigators, the CFR sections, topics and system areas they cite most, classifications and centers by year. Use for pre-inspection briefs.\n\nAlso callable as /api/intel/v1/call/get_investigator.\n\nSame as the MCP tool `get_investigator`.", "tags": [ "Firms and investigators" ], "parameters": [ { "name": "id", "in": "path", "required": true, "description": "Investigator id (slug) from search_investigators.", "schema": { "type": "string" } }, { "name": "limit", "in": "query", "required": false, "description": "Documents per page (default 100, max 500).", "schema": { "type": "integer", "minimum": 1, "maximum": 500 } }, { "name": "offset", "in": "query", "required": false, "description": "Skip this many results (use next_offset from the previous page).", "schema": { "type": "integer", "minimum": 0 } } ], "responses": { "200": { "description": "Success", "headers": { "X-RateLimit-Remaining": { "$ref": "#/components/headers/RateRemaining" }, "X-RateLimit-Limit": { "$ref": "#/components/headers/RateLimit" }, "X-RateLimit-Reset": { "$ref": "#/components/headers/RateReset" } }, "content": { "application/json": { "schema": { "type": "object" }, "example": { "investigator": { "id": "jane-example", "name": "Jane Example", "name_variants": [ "J. Example" ], "url": "https://fdaintel.ai/investigator/jane-example" }, "stats": { "documents": 48, "sites": 41, "first": "2016-02-09", "last": "2025-03-14", "form_483s": 44, "eirs": 4, "oai_inspections": 9, "classified_inspections": 40, "avg_observations_per_483": 5.8, "avg_inspection_days": 7 }, "top_cfr_sections": [ { "section": "211.192", "heading": "Production record review", "documents": 14, "citations": 17 } ], "top_topics": [ { "topic": "investigations", "observations": 21 } ], "sites_inspected": [ { "firm_name": "Example Pharma Ltd.", "firm_id": "3001234567", "fei": "3001234567", "country": "India", "documents": 2, "last": "2025-03-14", "types": [ "483" ] } ], "co_investigators": [ { "id": "sam-sample", "name": "Sam Sample", "documents": 6 } ], "documents": { "total": 48, "offset": 0, "limit": 25, "returned": 1, "next_offset": 1, "results": [ { "id": "ex4mpl3d0c01", "doc_type": "483", "label": null, "title": "Form 483 · Example Pharma Ltd. · 2025-03-14", "firm_name": "Example Pharma Ltd.", "firm_name_on_document": "Example Pharma Ltd.", "firm_id": "3001234567", "fei": "3001234567", "street": "1 Example Road", "city": "Hyderabad", "state": "Telangana", "zip": "500001", "country": "India", "document_date": "2025-03-14", "issue_date": "2025-03-14", "inspection_start": "2025-03-03", "inspection_end": "2025-03-14", "date_estimated": false, "center_program": "Drugs (CDER)", "establishment_type": "Manufacturer", "page_count": 9, "observation_count": 6, "investigator_names": "Jane Example", "summary": "Laboratory records were incomplete and out-of-specification results were not investigated.", "marcs_cms": null, "available": true, "has_text": true, "price_cents": 9900, "url": "https://fdaintel.ai/d/ex4mpl3d0c01", "owned": false } ] } } } } }, "400": { "$ref": "#/components/responses/E400" }, "401": { "$ref": "#/components/responses/E401" }, "403": { "$ref": "#/components/responses/E403" }, "404": { "$ref": "#/components/responses/E404" }, "429": { "$ref": "#/components/responses/E429" } } } }, "/api/intel/v1/cfr": { "get": { "operationId": "search_cfr", "summary": "Search regulations (21 CFR)", "description": "Find 21 CFR sections by citation (211.192, part 820) or words in the heading/text, with how often each is cited in 483s/EIRs and warning letters.\n\nAlso callable as /api/intel/v1/call/search_cfr.\n\nSame as the MCP tool `search_cfr`.", "tags": [ "Regulations and catalog" ], "parameters": [ { "name": "q", "in": "query", "required": false, "description": "Citation or words.", "schema": { "type": "string" } }, { "name": "limit", "in": "query", "required": false, "description": "Results per page (default 25, max 100).", "schema": { "type": "integer", "minimum": 1, "maximum": 100 } }, { "name": "offset", "in": "query", "required": false, "description": "Skip this many results (use next_offset from the previous page).", "schema": { "type": "integer", "minimum": 0 } } ], "responses": { "200": { "description": "Success", "headers": { "X-RateLimit-Remaining": { "$ref": "#/components/headers/RateRemaining" }, "X-RateLimit-Limit": { "$ref": "#/components/headers/RateLimit" }, "X-RateLimit-Reset": { "$ref": "#/components/headers/RateReset" } }, "content": { "application/json": { "schema": { "type": "object" }, "example": { "total": 1, "offset": 0, "limit": 25, "returned": 1, "next_offset": null, "results": [ { "citation": "211.192", "heading": "Production record review", "part": 211, "part_heading": "Current Good Manufacturing Practice for Finished Pharmaceuticals", "subpart": "J", "subpart_heading": "Records and Reports", "status": "current", "summary": "Requires the quality control unit to review and approve production and control records before release.", "documents_483_eir": 1200, "observation_citations": 1500, "warning_letters": 300 } ] } } } }, "400": { "$ref": "#/components/responses/E400" }, "401": { "$ref": "#/components/responses/E401" }, "403": { "$ref": "#/components/responses/E403" }, "404": { "$ref": "#/components/responses/E404" }, "429": { "$ref": "#/components/responses/E429" } } } }, "/api/intel/v1/cfr/{citation}": { "get": { "operationId": "get_cfr_section", "summary": "Regulation detail", "description": "One 21 CFR section: heading, full text, summary, firms cited most, sections cited alongside, observation topics, and the documents citing it (paged).\n\nAlso callable as /api/intel/v1/call/get_cfr_section.\n\nSame as the MCP tool `get_cfr_section`.", "tags": [ "Regulations and catalog" ], "parameters": [ { "name": "citation", "in": "path", "required": true, "description": "e.g. 211.192 or 21 CFR 820.100.", "schema": { "type": "string" } }, { "name": "limit", "in": "query", "required": false, "description": "Documents per page (default 50, max 200).", "schema": { "type": "integer", "minimum": 1, "maximum": 200 } }, { "name": "offset", "in": "query", "required": false, "description": "Skip this many results (use next_offset from the previous page).", "schema": { "type": "integer", "minimum": 0 } } ], "responses": { "200": { "description": "Success", "headers": { "X-RateLimit-Remaining": { "$ref": "#/components/headers/RateRemaining" }, "X-RateLimit-Limit": { "$ref": "#/components/headers/RateLimit" }, "X-RateLimit-Reset": { "$ref": "#/components/headers/RateReset" } }, "content": { "application/json": { "schema": { "type": "object" }, "example": { "section": { "citation": "211.192", "heading": "Production record review", "part": 211, "subpart": "J", "status": "current", "summary": "Requires the quality control unit to review and approve production and control records before release.", "body": "All drug product production and control records … shall be reviewed and approved by the quality control unit …" }, "top_firms": [ { "firm_name": "Example Pharma Ltd.", "firm_id": "3001234567", "fei": "3001234567", "documents": 3 } ], "cited_alongside": [ { "section": "211.22", "heading": "Responsibilities of quality control unit", "documents": 400 } ], "top_topics": [ { "topic": "investigations", "observations": 900 } ], "documents": { "total": 1200, "offset": 0, "limit": 10, "returned": 1, "next_offset": 1, "results": [ { "id": "ex4mpl3d0c01", "doc_type": "483", "label": null, "title": "Form 483 · Example Pharma Ltd. · 2025-03-14", "firm_name": "Example Pharma Ltd.", "firm_name_on_document": "Example Pharma Ltd.", "firm_id": "3001234567", "fei": "3001234567", "street": "1 Example Road", "city": "Hyderabad", "state": "Telangana", "zip": "500001", "country": "India", "document_date": "2025-03-14", "issue_date": "2025-03-14", "inspection_start": "2025-03-03", "inspection_end": "2025-03-14", "date_estimated": false, "center_program": "Drugs (CDER)", "establishment_type": "Manufacturer", "page_count": 9, "observation_count": 6, "investigator_names": "Jane Example", "summary": "Laboratory records were incomplete and out-of-specification results were not investigated.", "marcs_cms": null, "available": true, "has_text": true, "price_cents": 9900, "url": "https://fdaintel.ai/d/ex4mpl3d0c01", "owned": false } ] } } } } }, "400": { "$ref": "#/components/responses/E400" }, "401": { "$ref": "#/components/responses/E401" }, "403": { "$ref": "#/components/responses/E403" }, "404": { "$ref": "#/components/responses/E404" }, "429": { "$ref": "#/components/responses/E429" } } } }, "/api/intel/v1/facets": { "get": { "operationId": "list_facets", "summary": "Filter values and counts", "description": "Every filter value with its document count: document types, centers, establishment types, countries, states, product types, sectors, agencies, classifications, system areas, topics, years, warning-letter offices.\n\nAlso callable as /api/intel/v1/call/list_facets.\n\nSame as the MCP tool `list_facets`.", "tags": [ "Regulations and catalog" ], "parameters": [], "responses": { "200": { "description": "Success", "headers": { "X-RateLimit-Remaining": { "$ref": "#/components/headers/RateRemaining" }, "X-RateLimit-Limit": { "$ref": "#/components/headers/RateLimit" }, "X-RateLimit-Reset": { "$ref": "#/components/headers/RateReset" } }, "content": { "application/json": { "schema": { "type": "object" }, "example": { "scope": "visible documents", "doc_type": [ { "value": "483", "n": 6000 }, { "value": "warning_letter", "n": 9000 } ], "country": [ { "value": "India", "n": 700 } ], "topic": [ { "value": "data_integrity", "n": 1800 } ], "classification": [ { "value": "OAI", "n": 1200 } ], "year": [ { "value": 2025, "n": 1200 } ] } } } }, "400": { "$ref": "#/components/responses/E400" }, "401": { "$ref": "#/components/responses/E401" }, "403": { "$ref": "#/components/responses/E403" }, "404": { "$ref": "#/components/responses/E404" }, "429": { "$ref": "#/components/responses/E429" } } } }, "/api/intel/v1/stats": { "get": { "operationId": "catalog_stats", "summary": "Catalog statistics", "description": "Approximate size of the FDA Intel catalog: documents by type, observations, warning letters, firms, investigators and the date range.\n\nAlso callable as /api/intel/v1/call/catalog_stats.\n\nSame as the MCP tool `catalog_stats`.", "tags": [ "Regulations and catalog" ], "parameters": [], "responses": { "200": { "description": "Success", "headers": { "X-RateLimit-Remaining": { "$ref": "#/components/headers/RateRemaining" }, "X-RateLimit-Limit": { "$ref": "#/components/headers/RateLimit" }, "X-RateLimit-Reset": { "$ref": "#/components/headers/RateReset" } }, "content": { "application/json": { "schema": { "type": "object" }, "example": { "approximate": true, "documents": "20,000+", "observations": "30,000+", "warning_letters": "10,000+", "firms": "9,000+", "investigators": "2,000+", "earliest_document": "1996-01-01", "latest_document": "2025-10-31", "by_type": [ { "type": "Form 483", "documents": "6,000+" } ] } } } }, "400": { "$ref": "#/components/responses/E400" }, "401": { "$ref": "#/components/responses/E401" }, "403": { "$ref": "#/components/responses/E403" }, "404": { "$ref": "#/components/responses/E404" }, "429": { "$ref": "#/components/responses/E429" } } } }, "/api/intel/v1/call/find_facility": { "get": { "operationId": "find_facility", "summary": "Find a facility", "description": "Find FDA-regulated facilities by name (every word must match) or FEI, across FDA inspections and drug / device establishment registrations. Returns FEI, name, place, last inspection date and how many inspections. Follow with facility_signal.\n\nSame as the MCP tool `find_facility`.", "tags": [ "FDA public data" ], "parameters": [ { "name": "q", "in": "query", "required": false, "description": "Facility or firm name, e.g. 'Aurobindo Unit VII'.", "schema": { "type": "string" } }, { "name": "fei", "in": "query", "required": false, "description": "FDA Establishment Identifier (FEI) of the facility, digits only.", "schema": { "type": "string" } }, { "name": "country", "in": "query", "required": false, "description": "Country filter, e.g. India.", "schema": { "type": "string" } }, { "name": "limit", "in": "query", "required": false, "description": "Max results (default 20, max 50).", "schema": { "type": "integer", "minimum": 1, "maximum": 50 } } ], "responses": { "200": { "description": "Success", "headers": { "X-RateLimit-Remaining": { "$ref": "#/components/headers/RateRemaining" }, "X-RateLimit-Limit": { "$ref": "#/components/headers/RateLimit" }, "X-RateLimit-Reset": { "$ref": "#/components/headers/RateReset" } }, "content": { "application/json": { "schema": { "type": "object" }, "example": { "returned": 1, "results": [ { "fei": "3001234567", "name": "Example Pharma Ltd.", "city": "Hyderabad", "state": "Telangana", "country": "India", "last_inspection": "2025-03-14", "inspections": 4, "found_in": [ "inspected", "drug_registration" ] } ], "note": "Use facility_signal with an FEI for its current standing." } } } }, "400": { "$ref": "#/components/responses/E400" }, "401": { "$ref": "#/components/responses/E401" }, "403": { "$ref": "#/components/responses/E403" }, "404": { "$ref": "#/components/responses/E404" }, "429": { "$ref": "#/components/responses/E429" } } } }, "/api/intel/v1/call/facility_signal": { "get": { "operationId": "facility_signal", "summary": "Facility signal", "description": "A facility's current FDA standing by FEI, with a one-paragraph summary: last inspection and outcome (NAI/VAI/OAI), inspections in 5 years, warning letters and whether a close-out was posted, import alert status (red / yellow / green list), recent recalls, import refusals in 12 months, compliance actions, drug / device registration, and FDA Intel documents on file for the FEI.\n\nSame as the MCP tool `facility_signal`.", "tags": [ "FDA public data" ], "parameters": [ { "name": "fei", "in": "query", "required": true, "description": "FDA Establishment Identifier (FEI) of the facility, digits only.", "schema": { "type": "string" } } ], "responses": { "200": { "description": "Success", "headers": { "X-RateLimit-Remaining": { "$ref": "#/components/headers/RateRemaining" }, "X-RateLimit-Limit": { "$ref": "#/components/headers/RateLimit" }, "X-RateLimit-Reset": { "$ref": "#/components/headers/RateReset" } }, "content": { "application/json": { "schema": { "type": "object" }, "example": { "fei": "3001234567", "facility": { "name": "Example Pharma Ltd.", "street": "1 Example Road", "city": "Hyderabad", "state": "Telangana", "country": "India" }, "signal": "Last FDA inspection ended 2025-03-14 (OAI), Drug Quality Assurance. 3 inspections in 5 years (1 OAI, 2 VAI, 0 NAI). 1 warning letter on record (latest 2025-09-30), 1 without a posted close-out. Listed on import alert 66-40 (red list).", "last_inspection": { "inspection_id": 100001, "end_date": "2025-03-14", "classification": "OAI", "project_area": "Drug Quality Assurance", "product_type": "Drugs", "citations": 6 }, "inspections_last_5_years": { "inspections_5y": 3, "oai_5y": 1, "vai_5y": 2, "nai_5y": 0 }, "warning_letters": [ { "date": "2025-09-30", "marcs_cms": "700001", "subject": "CGMP/Finished Pharmaceuticals/Adulterated", "in_letter_index": true, "response_posted": false, "closeout_posted": null } ], "import_alerts": [ { "alert_no": "66-40", "list": "red", "listed_on": "2025-11-02" } ], "recent_recalls": [], "import_refusals": { "last_12_months": 2, "latest": "2025-12-01" }, "note": "From FDA public data (inspections, compliance actions, import alerts, recalls, registrations). Use inspection_history for every inspection and its citations.", "fda_intel_documents": { "total": 5, "recent": [ { "id": "ex4mpl3d0c01", "document": { "type": "Form 483", "date": "2025-03-14", "observations": 6, "pages": 9, "price_usd": 99, "link": "https://fdaintel.ai/d/ex4mpl3d0c01", "owned": false, "available_to_buy": true }, "firm_name": "Example Pharma Ltd." } ] } } } } }, "400": { "$ref": "#/components/responses/E400" }, "401": { "$ref": "#/components/responses/E401" }, "403": { "$ref": "#/components/responses/E403" }, "404": { "$ref": "#/components/responses/E404" }, "429": { "$ref": "#/components/responses/E429" } } } }, "/api/intel/v1/call/inspection_history": { "get": { "operationId": "inspection_history", "summary": "Inspection history with citations", "description": "Every FDA inspection of a facility (FEI), newest first: date, classification, project area, product type, and the 21 CFR citations FDA published for it with FDA's citation text.\n\nSame as the MCP tool `inspection_history`.", "tags": [ "FDA public data" ], "parameters": [ { "name": "fei", "in": "query", "required": true, "description": "FDA Establishment Identifier (FEI) of the facility, digits only.", "schema": { "type": "string" } }, { "name": "include_citations", "in": "query", "required": false, "description": "Include citations (default true).", "schema": { "type": "boolean" } }, { "name": "limit", "in": "query", "required": false, "description": "Results per page (default 25, max 100).", "schema": { "type": "integer", "minimum": 1, "maximum": 100 } }, { "name": "offset", "in": "query", "required": false, "description": "Skip this many results (use next_offset from the previous page).", "schema": { "type": "integer", "minimum": 0 } } ], "responses": { "200": { "description": "Success", "headers": { "X-RateLimit-Remaining": { "$ref": "#/components/headers/RateRemaining" }, "X-RateLimit-Limit": { "$ref": "#/components/headers/RateLimit" }, "X-RateLimit-Reset": { "$ref": "#/components/headers/RateReset" } }, "content": { "application/json": { "schema": { "type": "object" }, "example": { "fei": "3001234567", "total": 4, "offset": 0, "limit": 10, "returned": 1, "next_offset": 1, "results": [ { "inspection_id": 100001, "end_date": "2025-03-14", "fiscal_year": 2025, "classification": "OAI", "project_area": "Drug Quality Assurance", "product_type": "Drugs", "name": "Example Pharma Ltd.", "city": "Hyderabad", "state": null, "country": "India", "citations": [ { "cfr": "21 CFR 211.192", "short_desc": "Investigations of discrepancies, failures", "long_desc": "There was a failure to thoroughly review any unexplained discrepancy …" } ] } ] } } } }, "400": { "$ref": "#/components/responses/E400" }, "401": { "$ref": "#/components/responses/E401" }, "403": { "$ref": "#/components/responses/E403" }, "404": { "$ref": "#/components/responses/E404" }, "429": { "$ref": "#/components/responses/E429" } } } }, "/api/intel/v1/call/search_inspections": { "get": { "operationId": "search_inspections", "summary": "Search FDA inspections", "description": "Search FDA inspections across all firms by name, FEI, classification (NAI/VAI/OAI), project area, product type, country, state or date range. Newest first.\n\nSame as the MCP tool `search_inspections`.", "tags": [ "FDA public data" ], "parameters": [ { "name": "q", "in": "query", "required": false, "description": "Firm name words.", "schema": { "type": "string" } }, { "name": "fei", "in": "query", "required": false, "description": "FDA Establishment Identifier (FEI) of the facility, digits only.", "schema": { "type": "string" } }, { "name": "classification", "in": "query", "required": false, "description": "NAI, VAI or OAI.", "schema": { "type": "string", "enum": [ "NAI", "VAI", "OAI" ] } }, { "name": "project_area", "in": "query", "required": false, "description": "Project area contains, e.g. 'Drug Quality Assurance'.", "schema": { "type": "string" } }, { "name": "product_type", "in": "query", "required": false, "description": "Product type contains, e.g. Drugs, Devices.", "schema": { "type": "string" } }, { "name": "country", "in": "query", "required": false, "description": "Country.", "schema": { "type": "string" } }, { "name": "state", "in": "query", "required": false, "description": "US state code.", "schema": { "type": "string" } }, { "name": "date_from", "in": "query", "required": false, "description": "Earliest date, inclusive: 2023, 2023-06 or 2023-06-15.", "schema": { "type": "string" } }, { "name": "date_to", "in": "query", "required": false, "description": "Latest date, inclusive: 2024, 2024-03 or 2024-03-31.", "schema": { "type": "string" } }, { "name": "limit", "in": "query", "required": false, "description": "Results per page (default 25, max 100).", "schema": { "type": "integer", "minimum": 1, "maximum": 100 } }, { "name": "offset", "in": "query", "required": false, "description": "Skip this many results (use next_offset from the previous page).", "schema": { "type": "integer", "minimum": 0 } } ], "responses": { "200": { "description": "Success", "headers": { "X-RateLimit-Remaining": { "$ref": "#/components/headers/RateRemaining" }, "X-RateLimit-Limit": { "$ref": "#/components/headers/RateLimit" }, "X-RateLimit-Reset": { "$ref": "#/components/headers/RateReset" } }, "content": { "application/json": { "schema": { "type": "object" }, "example": { "total": 60, "offset": 0, "limit": 25, "returned": 1, "next_offset": 1, "results": [ { "fei": "3001234567", "name": "Example Pharma Ltd.", "city": "Hyderabad", "state": null, "country": "India", "inspection_id": 100001, "end_date": "2025-03-14", "classification": "OAI", "project_area": "Drug Quality Assurance", "product_type": "Drugs", "posted_citations": true } ] } } } }, "400": { "$ref": "#/components/responses/E400" }, "401": { "$ref": "#/components/responses/E401" }, "403": { "$ref": "#/components/responses/E403" }, "404": { "$ref": "#/components/responses/E404" }, "429": { "$ref": "#/components/responses/E429" } } } }, "/api/intel/v1/call/search_recalls": { "get": { "operationId": "search_recalls", "summary": "Search recalls", "description": "FDA recall enforcement reports (drugs, devices, food): by recalling firm, product or reason words, FEI, center, class (I, II, III), status, recall number or date range. Newest first.\n\nSame as the MCP tool `search_recalls`.", "tags": [ "FDA public data" ], "parameters": [ { "name": "firm", "in": "query", "required": false, "description": "Recalling firm name words.", "schema": { "type": "string" } }, { "name": "q", "in": "query", "required": false, "description": "Words in the product description or reason, e.g. 'sterility assurance'.", "schema": { "type": "string" } }, { "name": "fei", "in": "query", "required": false, "description": "FDA Establishment Identifier (FEI) of the facility, digits only.", "schema": { "type": "string" } }, { "name": "center", "in": "query", "required": false, "description": "drug, device or food.", "schema": { "type": "string", "enum": [ "drug", "device", "food" ] } }, { "name": "classification", "in": "query", "required": false, "description": "Class I, Class II or Class III.", "schema": { "type": "string" } }, { "name": "status", "in": "query", "required": false, "description": "Ongoing, Completed or Terminated.", "schema": { "type": "string" } }, { "name": "recall_number", "in": "query", "required": false, "description": "e.g. D-0123-2024.", "schema": { "type": "string" } }, { "name": "date_from", "in": "query", "required": false, "description": "Earliest date, inclusive: 2023, 2023-06 or 2023-06-15.", "schema": { "type": "string" } }, { "name": "date_to", "in": "query", "required": false, "description": "Latest date, inclusive: 2024, 2024-03 or 2024-03-31.", "schema": { "type": "string" } }, { "name": "limit", "in": "query", "required": false, "description": "Results per page (default 25, max 100).", "schema": { "type": "integer", "minimum": 1, "maximum": 100 } }, { "name": "offset", "in": "query", "required": false, "description": "Skip this many results (use next_offset from the previous page).", "schema": { "type": "integer", "minimum": 0 } } ], "responses": { "200": { "description": "Success", "headers": { "X-RateLimit-Remaining": { "$ref": "#/components/headers/RateRemaining" }, "X-RateLimit-Limit": { "$ref": "#/components/headers/RateLimit" }, "X-RateLimit-Reset": { "$ref": "#/components/headers/RateReset" } }, "content": { "application/json": { "schema": { "type": "object" }, "example": { "total": 1, "offset": 0, "limit": 25, "returned": 1, "next_offset": null, "results": [ { "recall_number": "D-0001-2025", "event_id": "90001", "center": "drug", "classification": "Class II", "status": "Ongoing", "firm": "Example Pharma Ltd.", "country": "India", "initiated": "2025-01-20", "classified": "2025-02-11", "terminated": null, "voluntary_mandated": "Voluntary: Firm initiated", "product": "Example tablets, 10 mg, 30-count bottles", "reason": "Failed dissolution specifications", "distribution_pattern": "Nationwide", "application_numbers": [ "ANDA000001" ] } ] } } } }, "400": { "$ref": "#/components/responses/E400" }, "401": { "$ref": "#/components/responses/E401" }, "403": { "$ref": "#/components/responses/E403" }, "404": { "$ref": "#/components/responses/E404" }, "429": { "$ref": "#/components/responses/E429" } } } }, "/api/intel/v1/call/search_import_alerts": { "get": { "operationId": "search_import_alerts", "summary": "Import alerts", "description": "FDA import alerts. With alert_no: the alert and the firms on its red / yellow / green lists. With firm, FEI, country or list: matching listed firms. With only q (or nothing): the alerts themselves by title or number.\n\nSame as the MCP tool `search_import_alerts`.", "tags": [ "FDA public data" ], "parameters": [ { "name": "alert_no", "in": "query", "required": false, "description": "e.g. 66-40.", "schema": { "type": "string" } }, { "name": "firm", "in": "query", "required": false, "description": "Firm name words.", "schema": { "type": "string" } }, { "name": "fei", "in": "query", "required": false, "description": "FDA Establishment Identifier (FEI) of the facility, digits only.", "schema": { "type": "string" } }, { "name": "country", "in": "query", "required": false, "description": "Country.", "schema": { "type": "string" } }, { "name": "list", "in": "query", "required": false, "description": "red (detention without examination), yellow or green (exempted).", "schema": { "type": "string", "enum": [ "red", "yellow", "green" ] } }, { "name": "q", "in": "query", "required": false, "description": "Words in an alert title.", "schema": { "type": "string" } }, { "name": "limit", "in": "query", "required": false, "description": "Results per page (default 25, max 100).", "schema": { "type": "integer", "minimum": 1, "maximum": 100 } }, { "name": "offset", "in": "query", "required": false, "description": "Skip this many results (use next_offset from the previous page).", "schema": { "type": "integer", "minimum": 0 } } ], "responses": { "200": { "description": "Success", "headers": { "X-RateLimit-Remaining": { "$ref": "#/components/headers/RateRemaining" }, "X-RateLimit-Limit": { "$ref": "#/components/headers/RateLimit" }, "X-RateLimit-Reset": { "$ref": "#/components/headers/RateReset" } }, "content": { "application/json": { "schema": { "type": "object" }, "example": { "total": 1, "offset": 0, "limit": 25, "returned": 1, "next_offset": null, "results": [ { "alert_no": "66-40", "alert_title": "Detention without physical examination of drugs from firms which have not met drug GMPs", "list": "red", "firm_name": "Example Pharma Ltd.", "city": "Hyderabad", "country": "India", "fei": "3001234567", "listed_on": "2025-11-02", "products": "All drug products" } ] } } } }, "400": { "$ref": "#/components/responses/E400" }, "401": { "$ref": "#/components/responses/E401" }, "403": { "$ref": "#/components/responses/E403" }, "404": { "$ref": "#/components/responses/E404" }, "429": { "$ref": "#/components/responses/E429" } } } }, "/api/intel/v1/call/warning_letter_status": { "get": { "operationId": "warning_letter_status", "summary": "Warning-letter status", "description": "FDA's warning-letter index: company, issue and posting dates, issuing office, subject, and whether a response and a close-out letter were posted. Filter by company, MARCS-CMS number, office, subject words, closed_out or date range.\n\nSame as the MCP tool `warning_letter_status`.", "tags": [ "FDA public data" ], "parameters": [ { "name": "company", "in": "query", "required": false, "description": "Company name words.", "schema": { "type": "string" } }, { "name": "marcs_cms", "in": "query", "required": false, "description": "MARCS-CMS number.", "schema": { "type": "string" } }, { "name": "issuing_office", "in": "query", "required": false, "description": "Issuing office contains.", "schema": { "type": "string" } }, { "name": "subject", "in": "query", "required": false, "description": "Subject contains, e.g. CGMP.", "schema": { "type": "string" } }, { "name": "closed_out", "in": "query", "required": false, "description": "Only letters with (true) or without (false) a posted close-out.", "schema": { "type": "boolean" } }, { "name": "date_from", "in": "query", "required": false, "description": "Earliest date, inclusive: 2023, 2023-06 or 2023-06-15.", "schema": { "type": "string" } }, { "name": "date_to", "in": "query", "required": false, "description": "Latest date, inclusive: 2024, 2024-03 or 2024-03-31.", "schema": { "type": "string" } }, { "name": "limit", "in": "query", "required": false, "description": "Results per page (default 25, max 100).", "schema": { "type": "integer", "minimum": 1, "maximum": 100 } }, { "name": "offset", "in": "query", "required": false, "description": "Skip this many results (use next_offset from the previous page).", "schema": { "type": "integer", "minimum": 0 } } ], "responses": { "200": { "description": "Success", "headers": { "X-RateLimit-Remaining": { "$ref": "#/components/headers/RateRemaining" }, "X-RateLimit-Limit": { "$ref": "#/components/headers/RateLimit" }, "X-RateLimit-Reset": { "$ref": "#/components/headers/RateReset" } }, "content": { "application/json": { "schema": { "type": "object" }, "example": { "total": 1, "offset": 0, "limit": 25, "returned": 1, "next_offset": null, "results": [ { "marcs_cms": "700001", "company": "Example Pharma Ltd.", "issued": "2025-09-30", "posted": "2025-10-14", "issuing_office": "Center for Drug Evaluation and Research (CDER)", "subject": "CGMP/Finished Pharmaceuticals/Adulterated", "response_posted": null, "closeout_posted": null, "fda_intel_documents": [ { "id": "ex4mpl3d0c02", "document": { "type": "Warning letter", "date": "2025-09-30", "observations": 3, "pages": 6, "price_usd": 99, "link": "https://fdaintel.ai/d/ex4mpl3d0c02", "owned": false, "available_to_buy": true } } ] } ] } } } }, "400": { "$ref": "#/components/responses/E400" }, "401": { "$ref": "#/components/responses/E401" }, "403": { "$ref": "#/components/responses/E403" }, "404": { "$ref": "#/components/responses/E404" }, "429": { "$ref": "#/components/responses/E429" } } } }, "/api/intel/v1/call/drug_shortages": { "get": { "operationId": "drug_shortages", "summary": "Drug shortages", "description": "FDA drug shortage list: generic name, company, presentation, status (Current, To Be Discontinued, Resolved), availability, reason and dates.\n\nSame as the MCP tool `drug_shortages`.", "tags": [ "FDA public data" ], "parameters": [ { "name": "q", "in": "query", "required": false, "description": "Drug name words, e.g. 'cisplatin'.", "schema": { "type": "string" } }, { "name": "company", "in": "query", "required": false, "description": "Company name words.", "schema": { "type": "string" } }, { "name": "status", "in": "query", "required": false, "description": "Current, To Be Discontinued or Resolved.", "schema": { "type": "string" } }, { "name": "limit", "in": "query", "required": false, "description": "Results per page (default 25, max 100).", "schema": { "type": "integer", "minimum": 1, "maximum": 100 } }, { "name": "offset", "in": "query", "required": false, "description": "Skip this many results (use next_offset from the previous page).", "schema": { "type": "integer", "minimum": 0 } } ], "responses": { "200": { "description": "Success", "headers": { "X-RateLimit-Remaining": { "$ref": "#/components/headers/RateRemaining" }, "X-RateLimit-Limit": { "$ref": "#/components/headers/RateLimit" }, "X-RateLimit-Reset": { "$ref": "#/components/headers/RateReset" } }, "content": { "application/json": { "schema": { "type": "object" }, "example": { "total": 1, "offset": 0, "limit": 25, "returned": 1, "next_offset": null, "results": [ { "generic_name": "Cisplatin Injection", "company": "Example Generics Inc.", "presentation": "50 mg/50 mL vial", "package_ndc": "00000-0001-01", "dosage_form": "Injection", "status": "Current", "availability": "Limited supply", "shortage_reason": "Demand increase", "therapeutic_categories": [ "Oncology" ], "first_posted": "2025-04-01", "updated": "2025-10-20", "discontinued": null } ] } } } }, "400": { "$ref": "#/components/responses/E400" }, "401": { "$ref": "#/components/responses/E401" }, "403": { "$ref": "#/components/responses/E403" }, "404": { "$ref": "#/components/responses/E404" }, "429": { "$ref": "#/components/responses/E429" } } } }, "/api/intel/v1/call/search_registrations": { "get": { "operationId": "search_registrations", "summary": "Establishment registrations", "description": "FDA establishment registrations. kind=drug: registered drug establishments (FEI, DUNS, operations, registration expiry). kind=device: registered device establishments (registration number, FEI, establishment types, product codes).\n\nSame as the MCP tool `search_registrations`.", "tags": [ "FDA public data" ], "parameters": [ { "name": "kind", "in": "query", "required": false, "description": "drug (default) or device.", "schema": { "type": "string", "enum": [ "drug", "device" ] } }, { "name": "q", "in": "query", "required": false, "description": "Establishment or owner name words.", "schema": { "type": "string" } }, { "name": "fei", "in": "query", "required": false, "description": "FDA Establishment Identifier (FEI) of the facility, digits only.", "schema": { "type": "string" } }, { "name": "country", "in": "query", "required": false, "description": "Country (drug) or 2-letter ISO code (device).", "schema": { "type": "string" } }, { "name": "product_code", "in": "query", "required": false, "description": "Device product code, e.g. FRN (device only).", "schema": { "type": "string" } }, { "name": "limit", "in": "query", "required": false, "description": "Results per page (default 25, max 100).", "schema": { "type": "integer", "minimum": 1, "maximum": 100 } }, { "name": "offset", "in": "query", "required": false, "description": "Skip this many results (use next_offset from the previous page).", "schema": { "type": "integer", "minimum": 0 } } ], "responses": { "200": { "description": "Success", "headers": { "X-RateLimit-Remaining": { "$ref": "#/components/headers/RateRemaining" }, "X-RateLimit-Limit": { "$ref": "#/components/headers/RateLimit" }, "X-RateLimit-Reset": { "$ref": "#/components/headers/RateReset" } }, "content": { "application/json": { "schema": { "type": "object" }, "example": { "kind": "drug", "total": 1, "offset": 0, "limit": 25, "returned": 1, "next_offset": null, "results": [ { "fei": "3001234567", "duns": "000000001", "firm_name": "Example Pharma Ltd.", "address": "1 Example Road, Hyderabad", "country": "India", "registration_expires": "2026-12-31", "operations": [ "API manufacture", "Analysis" ], "registrant_name": "Example Pharma Ltd.", "excluded": false } ] } } } }, "400": { "$ref": "#/components/responses/E400" }, "401": { "$ref": "#/components/responses/E401" }, "403": { "$ref": "#/components/responses/E403" }, "404": { "$ref": "#/components/responses/E404" }, "429": { "$ref": "#/components/responses/E429" } } } }, "/api/intel/v1/call/lookup_510k": { "get": { "operationId": "lookup_510k", "summary": "510(k) clearances", "description": "Device 510(k) clearances by K number, device / applicant words, applicant, product code or decision date range, with the device class and regulation number.\n\nSame as the MCP tool `lookup_510k`.", "tags": [ "FDA public data" ], "parameters": [ { "name": "k_number", "in": "query", "required": false, "description": "e.g. K213456.", "schema": { "type": "string" } }, { "name": "q", "in": "query", "required": false, "description": "Device or applicant words.", "schema": { "type": "string" } }, { "name": "applicant", "in": "query", "required": false, "description": "Applicant name words.", "schema": { "type": "string" } }, { "name": "product_code", "in": "query", "required": false, "description": "Product code, e.g. DQY.", "schema": { "type": "string" } }, { "name": "date_from", "in": "query", "required": false, "description": "Earliest date, inclusive: 2023, 2023-06 or 2023-06-15.", "schema": { "type": "string" } }, { "name": "date_to", "in": "query", "required": false, "description": "Latest date, inclusive: 2024, 2024-03 or 2024-03-31.", "schema": { "type": "string" } }, { "name": "limit", "in": "query", "required": false, "description": "Results per page (default 25, max 100).", "schema": { "type": "integer", "minimum": 1, "maximum": 100 } }, { "name": "offset", "in": "query", "required": false, "description": "Skip this many results (use next_offset from the previous page).", "schema": { "type": "integer", "minimum": 0 } } ], "responses": { "200": { "description": "Success", "headers": { "X-RateLimit-Remaining": { "$ref": "#/components/headers/RateRemaining" }, "X-RateLimit-Limit": { "$ref": "#/components/headers/RateLimit" }, "X-RateLimit-Reset": { "$ref": "#/components/headers/RateReset" } }, "content": { "application/json": { "schema": { "type": "object" }, "example": { "total": 1, "offset": 0, "limit": 25, "returned": 1, "next_offset": null, "results": [ { "k_number": "K000001", "applicant": "Example Devices Inc.", "device_name": "Example infusion pump", "product_code": "FRN", "device_class": "2", "regulation_number": "880.5725", "received": "2024-11-02", "decided": "2025-04-18", "decision_description": "Substantially Equivalent", "clearance_type": "Traditional", "advisory_committee": "General Hospital", "city": "Boston", "state": "MA", "country": "US" } ] } } } }, "400": { "$ref": "#/components/responses/E400" }, "401": { "$ref": "#/components/responses/E401" }, "403": { "$ref": "#/components/responses/E403" }, "404": { "$ref": "#/components/responses/E404" }, "429": { "$ref": "#/components/responses/E429" } } } }, "/api/intel/v1/call/lookup_pma": { "get": { "operationId": "lookup_pma", "summary": "PMA approvals", "description": "Device premarket approvals (PMA) by PMA number, trade / generic name or applicant words, or product code. First approvals only by default; include_supplements=true adds supplements.\n\nSame as the MCP tool `lookup_pma`.", "tags": [ "FDA public data" ], "parameters": [ { "name": "pma_number", "in": "query", "required": false, "description": "e.g. P200012.", "schema": { "type": "string" } }, { "name": "q", "in": "query", "required": false, "description": "Trade name, generic name or applicant words.", "schema": { "type": "string" } }, { "name": "product_code", "in": "query", "required": false, "description": "Product code.", "schema": { "type": "string" } }, { "name": "include_supplements", "in": "query", "required": false, "description": "Include PMA supplements (default false).", "schema": { "type": "boolean" } }, { "name": "limit", "in": "query", "required": false, "description": "Results per page (default 25, max 100).", "schema": { "type": "integer", "minimum": 1, "maximum": 100 } }, { "name": "offset", "in": "query", "required": false, "description": "Skip this many results (use next_offset from the previous page).", "schema": { "type": "integer", "minimum": 0 } } ], "responses": { "200": { "description": "Success", "headers": { "X-RateLimit-Remaining": { "$ref": "#/components/headers/RateRemaining" }, "X-RateLimit-Limit": { "$ref": "#/components/headers/RateLimit" }, "X-RateLimit-Reset": { "$ref": "#/components/headers/RateReset" } }, "content": { "application/json": { "schema": { "type": "object" }, "example": { "total": 1, "offset": 0, "limit": 25, "returned": 1, "next_offset": null, "results": [ { "pma_number": "P000001", "supplement": null, "applicant": "Example Devices Inc.", "trade_name": "Example Stent System", "generic_name": "Coronary drug-eluting stent", "product_code": "NIQ", "received": "2023-06-01", "decided": "2024-08-15", "decision_code": "APPR", "supplement_type": null, "supplement_reason": null, "advisory_committee": "Cardiovascular" } ] } } } }, "400": { "$ref": "#/components/responses/E400" }, "401": { "$ref": "#/components/responses/E401" }, "403": { "$ref": "#/components/responses/E403" }, "404": { "$ref": "#/components/responses/E404" }, "429": { "$ref": "#/components/responses/E429" } } } }, "/api/intel/v1/call/lookup_ndc": { "get": { "operationId": "lookup_ndc", "summary": "NDC directory", "description": "Drug products in the NDC directory by NDC, brand / generic name words, labeler or application number: dosage form, route, marketing category and dates, active ingredients.\n\nSame as the MCP tool `lookup_ndc`.", "tags": [ "FDA public data" ], "parameters": [ { "name": "ndc", "in": "query", "required": false, "description": "Product NDC, e.g. 0002-1433.", "schema": { "type": "string" } }, { "name": "q", "in": "query", "required": false, "description": "Brand or generic name words.", "schema": { "type": "string" } }, { "name": "labeler", "in": "query", "required": false, "description": "Labeler name words.", "schema": { "type": "string" } }, { "name": "application_number", "in": "query", "required": false, "description": "e.g. NDA021436.", "schema": { "type": "string" } }, { "name": "limit", "in": "query", "required": false, "description": "Results per page (default 25, max 100).", "schema": { "type": "integer", "minimum": 1, "maximum": 100 } }, { "name": "offset", "in": "query", "required": false, "description": "Skip this many results (use next_offset from the previous page).", "schema": { "type": "integer", "minimum": 0 } } ], "responses": { "200": { "description": "Success", "headers": { "X-RateLimit-Remaining": { "$ref": "#/components/headers/RateRemaining" }, "X-RateLimit-Limit": { "$ref": "#/components/headers/RateLimit" }, "X-RateLimit-Reset": { "$ref": "#/components/headers/RateReset" } }, "content": { "application/json": { "schema": { "type": "object" }, "example": { "total": 1, "offset": 0, "limit": 25, "returned": 1, "next_offset": null, "results": [ { "product_ndc": "00000-0001", "brand_name": "Examplomab", "generic_name": "examplomab", "labeler": "Example Biologics Inc.", "dosage_form": "INJECTION, SOLUTION", "routes": [ "INTRAVENOUS" ], "product_type": "HUMAN PRESCRIPTION DRUG", "marketing_category": "BLA", "application_number": "BLA000001", "marketing_start": "2023-05-01", "marketing_end": null, "active_ingredients": [ { "name": "EXAMPLOMAB", "strength": "100 mg/10mL" } ], "pharm_class": [] } ] } } } }, "400": { "$ref": "#/components/responses/E400" }, "401": { "$ref": "#/components/responses/E401" }, "403": { "$ref": "#/components/responses/E403" }, "404": { "$ref": "#/components/responses/E404" }, "429": { "$ref": "#/components/responses/E429" } } } }, "/api/intel/v1/call/lookup_drug_application": { "get": { "operationId": "lookup_drug_application", "summary": "Drug applications (Drugs@FDA)", "description": "Approved drug applications (NDA, ANDA, BLA) by application number, brand / ingredient words or sponsor: first approval, last submission, products and (by number) the submission history.\n\nSame as the MCP tool `lookup_drug_application`.", "tags": [ "FDA public data" ], "parameters": [ { "name": "application_number", "in": "query", "required": false, "description": "e.g. NDA021436 or ANDA076543.", "schema": { "type": "string" } }, { "name": "q", "in": "query", "required": false, "description": "Brand name or active ingredient.", "schema": { "type": "string" } }, { "name": "sponsor", "in": "query", "required": false, "description": "Sponsor name words.", "schema": { "type": "string" } }, { "name": "limit", "in": "query", "required": false, "description": "Results per page (default 25, max 100).", "schema": { "type": "integer", "minimum": 1, "maximum": 100 } }, { "name": "offset", "in": "query", "required": false, "description": "Skip this many results (use next_offset from the previous page).", "schema": { "type": "integer", "minimum": 0 } } ], "responses": { "200": { "description": "Success", "headers": { "X-RateLimit-Remaining": { "$ref": "#/components/headers/RateRemaining" }, "X-RateLimit-Limit": { "$ref": "#/components/headers/RateLimit" }, "X-RateLimit-Reset": { "$ref": "#/components/headers/RateReset" } }, "content": { "application/json": { "schema": { "type": "object" }, "example": { "total": 1, "offset": 0, "limit": 25, "returned": 1, "next_offset": null, "results": [ { "application_number": "ANDA000001", "sponsor": "Example Generics Inc.", "first_approval": "2019-07-02", "last_submission": "2025-02-14", "brand_names": [ "EXAMPLE TABLETS" ], "active_ingredients": [ "EXAMPLAZOLE" ], "marketing_statuses": [ "Prescription" ], "products": [ { "product_number": "001", "dosage_form": "TABLET", "strength": "10MG" } ], "submissions": [ { "type": "ORIG", "number": "1", "status": "AP", "date": "2019-07-02" } ] } ] } } } }, "400": { "$ref": "#/components/responses/E400" }, "401": { "$ref": "#/components/responses/E401" }, "403": { "$ref": "#/components/responses/E403" }, "404": { "$ref": "#/components/responses/E404" }, "429": { "$ref": "#/components/responses/E429" } } } }, "/api/intel/v1/call/check_debarment": { "get": { "operationId": "check_debarment", "summary": "Debarment check", "description": "Check a person or firm name against FDA's debarment list and the clinical investigator disqualification list (name match only).\n\nSame as the MCP tool `check_debarment`.", "tags": [ "FDA public data" ], "parameters": [ { "name": "q", "in": "query", "required": true, "description": "Person or firm name.", "schema": { "type": "string" } } ], "responses": { "200": { "description": "Success", "headers": { "X-RateLimit-Remaining": { "$ref": "#/components/headers/RateRemaining" }, "X-RateLimit-Limit": { "$ref": "#/components/headers/RateLimit" }, "X-RateLimit-Reset": { "$ref": "#/components/headers/RateReset" } }, "content": { "application/json": { "schema": { "type": "object" }, "example": { "debarments": [], "clinical_investigator_disqualifications": [], "note": "No match on the FDA debarment list or the clinical investigator disqualification list." } } } }, "400": { "$ref": "#/components/responses/E400" }, "401": { "$ref": "#/components/responses/E401" }, "403": { "$ref": "#/components/responses/E403" }, "404": { "$ref": "#/components/responses/E404" }, "429": { "$ref": "#/components/responses/E429" } } } } }, "components": { "securitySchemes": { "apiKey": { "type": "http", "scheme": "bearer", "description": "A personal API key (fdi_ak_…) from your account page, sent as Authorization: Bearer ." }, "oauth2": { "type": "oauth2", "description": "OAuth 2.1 authorization code with PKCE (S256). Clients can register themselves (RFC 7591).", "flows": { "authorizationCode": { "authorizationUrl": "https://fdaintel.ai/oauth/authorize", "tokenUrl": "https://fdaintel.ai/oauth/token", "refreshUrl": "https://fdaintel.ai/oauth/token", "scopes": { "intel:read": "Read FDA Intel data" } } } } }, "headers": { "RateLimit": { "description": "The limit that applies right now (daily cap or monthly allowance).", "schema": { "type": "integer" } }, "RateRemaining": { "description": "Requests left under that limit.", "schema": { "type": "integer" } }, "RateReset": { "description": "Seconds until that limit resets.", "schema": { "type": "integer" } } }, "schemas": { "Error": { "type": "object", "required": [ "error" ], "properties": { "error": { "type": "string" }, "error_description": { "type": "string" } } } }, "responses": { "E400": { "description": "Invalid request", "content": { "application/json": { "schema": { "$ref": "#/components/schemas/Error" }, "example": { "error": "invalid_request", "error_description": "Give a facility name (q) or an FEI number (fei)." } } } }, "E401": { "description": "Missing or invalid credential", "content": { "application/json": { "schema": { "$ref": "#/components/schemas/Error" }, "example": { "error": "unauthorized", "error_description": "Sign in to FDA Intel to use this API." } } } }, "E403": { "description": "No active plan", "content": { "application/json": { "schema": { "$ref": "#/components/schemas/Error" }, "example": { "error": "subscription_required", "error_description": "This FDA Intel account has no active Standard or Premium plan." } } } }, "E404": { "description": "Not found", "content": { "application/json": { "schema": { "$ref": "#/components/schemas/Error" }, "example": { "error": "not_found", "error_description": "No document with id ex4mpl3d0c01." } } } }, "E429": { "description": "Limit reached", "content": { "application/json": { "schema": { "$ref": "#/components/schemas/Error" }, "example": { "error": "limit_reached", "error_description": "Today's limit is reached: 1,000 requests a day on the Standard plan. It resets at midnight UTC." } } } } } } }