Tools reference

Inspection documents

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. Each tool is an MCP tool and a REST endpoint with the same name and parameters.

searchSearch FDA Intel documents#

GET/api/intel/v1/call/searchMCP tool: searchread-only

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.

Parameters

NameDescription

querystringrequired

What to look for, e.g. 'Sun Pharma Halol data integrity' or 'aseptic processing 211.113'.

Example request

curl "https://fdaintel.ai/api/intel/v1/call/search?query=Example+Pharma+data+integrity+211.194" \
  -H "Authorization: Bearer $FDA_INTEL_API_KEY"

Example response (200, shortened, made-up values)

200 OK · application/json

{
  "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."
    }
  ]
}

fetchFetch a document#

GET/api/intel/v1/call/fetchMCP tool: fetchread-only

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.

Parameters

NameDescription

idstringrequired

Document id from search.

Example request

curl "https://fdaintel.ai/api/intel/v1/call/fetch?id=ex4mpl3d0c01" \
  -H "Authorization: Bearer $FDA_INTEL_API_KEY"

Example response (200, shortened, made-up values)

200 OK · application/json

{
  "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"
  }
}

search_documentsSearch documents with filters#

GET/api/intel/v1/documentsMCP tool: search_documentsread-only

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.

Also callable as /api/intel/v1/call/search_documents.

Parameters

NameDescription

qstring

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.

doc_typearray of string

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. One of: 483, 483_amended, eir, 483_response, warning_letter, wl_response, untitled_letter, untitled_letter_response, close_out_letter, import_alert, fda_correspondence, other.

firmstring

Firm / site name contains (case-insensitive; also matches known aliases).

firm_idstring

Exact firm id (slug from search_firms) or numeric firm id.

feistring

Exact FDA Establishment Identifier (FEI) of the inspected site.

investigatorstring

Investigator name contains (case-insensitive, any name variant).

investigator_idstring

Exact investigator id (slug from search_investigators).

citystring

City (exact, case-insensitive).

statestring

US state or province code/name (exact, case-insensitive), e.g. NJ.

countrystring

Country (exact, case-insensitive), e.g. India. 'US'/'USA'/'United States' all match the United States.

date_fromstring

Earliest date, inclusive: 2023, 2023-06 or 2023-06-15.

date_tostring

Latest date, inclusive: 2024, 2024-03 or 2024-03-31.

date_fieldstring

Which date the range applies to: document (default: issue date, else inspection end/start), issue, inspection_start, inspection_end. One of: document, issue, inspection_start, inspection_end.

cfrstring

Cited regulation: a 21 CFR section (211.192) or a whole part (211, 820). Matches 483 observations and warning-letter violations.

observationstring

Full-text search within 483 observation statements and warning-letter violation headings only.

centerstring

FDA center / program contains, e.g. CDER, CDRH, Biologics, Foods, Tobacco, compounding.

establishment_typestring

Establishment type contains, e.g. 'Manufacturer', 'Outsourcing Facility'.

product_typestring

Product type contains (from FDA inspection data and warning letters): Drugs, Devices, Biologics, Food/Cosmetics, Veterinary, Tobacco …

sectorstring

Establishment sector: drugs, devices, food, blood_biologics, vet, tobacco, bimo.

inspecting_agencystring

fda, state_under_fda_contract or state_local.

classificationarray of string

FDA inspection classification of the matched inspection. One of: NAI, VAI, OAI.

system_areastring

Quality system area of an observation/violation contains, e.g. drug:laboratory, device:capa (see list_facets).

topicstring

Observation topic, e.g. aseptic_sterility, data_integrity, cleaning_validation (exact; see list_facets).

repeatboolean

Only documents with an explicit repeat observation / repeat violation.

issuing_officestring

Warning letters: issuing office contains.

marcs_cmsstring

Exact MARCS-CMS case number (warning letters, close-outs).

has_summaryboolean

Only documents with (true) or without (false) a written summary.

has_textboolean

Only documents with (true) or without (false) extracted text.

has_observationsboolean

Only documents with (true) or without (false) extracted observations.

availableboolean

Only documents that are (true) or are not (false) available to buy as a PDF.

min_observationsinteger

At least this many observations.

min_pagesinteger

At least this many pages.

sortstring

relevance (default with q), date_desc (default otherwise), date_asc, firm, observations, added_desc. One of: relevance, date_desc, date_asc, firm, observations, added_desc.

limitinteger

Results per page (default 25, max 100).

offsetinteger

Skip this many results (use next_offset from the previous page).

Example request

curl "https://fdaintel.ai/api/intel/v1/documents?fei=3001234567&doc_type=483%2Cwarning_letter&date_from=2020&limit=10" \
  -H "Authorization: Bearer $FDA_INTEL_API_KEY"

Example response (200, shortened, made-up values)

200 OK · application/json

{
  "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"
}

get_documentGet everything about a document#

GET/api/intel/v1/documents/{id}MCP tool: get_documentread-only

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.

Also callable as /api/intel/v1/call/get_document.

Parameters

NameDescription

idstring, in pathrequired

Document id (the public id, e.g. 'dfjgwg9kdht2', as returned by search).

Example request

curl "https://fdaintel.ai/api/intel/v1/documents/ex4mpl3d0c01" \
  -H "Authorization: Bearer $FDA_INTEL_API_KEY"

Example response (200, shortened, made-up values)

200 OK · application/json

{
  "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"
}

search_observationsSearch observations and violations#

GET/api/intel/v1/observationsMCP tool: search_observationsread-only

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.

Also callable as /api/intel/v1/call/search_observations.

Parameters

NameDescription

qstring

Full-text search in observation statements / violation headings.

kindstring

all (default), 483 or warning_letter. One of: all, 483, warning_letter.

cfrstring

Cited regulation: a 21 CFR section (211.192) or a whole part (211, 820). Matches 483 observations and warning-letter violations.

system_areastring

Quality system area of an observation/violation contains, e.g. drug:laboratory, device:capa (see list_facets).

topicstring

Observation topic, e.g. aseptic_sterility, data_integrity, cleaning_validation (exact; see list_facets).

repeatboolean

Only repeat observations / violations.

firmstring

Firm / site name contains (case-insensitive; also matches known aliases).

firm_idstring

Exact firm id (slug from search_firms) or numeric firm id.

feistring

Exact FDA Establishment Identifier (FEI) of the inspected site.

investigatorstring

Investigator name contains (case-insensitive, any name variant).

investigator_idstring

Exact investigator id (slug from search_investigators).

doc_typearray of string

countrystring

Country (exact, case-insensitive), e.g. India. 'US'/'USA'/'United States' all match the United States.

statestring

US state or province code/name (exact, case-insensitive), e.g. NJ.

date_fromstring

Earliest date, inclusive: 2023, 2023-06 or 2023-06-15.

date_tostring

Latest date, inclusive: 2024, 2024-03 or 2024-03-31.

centerstring

FDA center / program contains, e.g. CDER, CDRH, Biologics, Foods, Tobacco, compounding.

product_typestring

Product type contains (from FDA inspection data and warning letters): Drugs, Devices, Biologics, Food/Cosmetics, Veterinary, Tobacco …

limitinteger

Results per page (default 25, max 100).

offsetinteger

Skip this many results (use next_offset from the previous page).

Example request

curl "https://fdaintel.ai/api/intel/v1/observations?cfr=211.192&topic=investigations&date_from=2023&limit=10" \
  -H "Authorization: Bearer $FDA_INTEL_API_KEY"

Example response (200, shortened, made-up values)

200 OK · application/json

{
  "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
    }
  ]
}