FDA Intel

Tools reference

Regulations and catalog

21 CFR sections with how often FDA cites them, filter values and catalog totals. Each tool is an MCP tool and a REST endpoint with the same name and parameters.

search_cfrSearch regulations (21 CFR)#

GET/api/intel/v1/cfrMCP tool: search_cfrread-only

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.

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

Parameters

qstring
Citation or words.
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/cfr?q=211.192" \
  -H "Authorization: Bearer $FDA_INTEL_API_KEY"
Example response (200, shortened, made-up values)
200 OK · application/json
{
  "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
    }
  ]
}

get_cfr_sectionRegulation detail#

GET/api/intel/v1/cfr/{citation}MCP tool: get_cfr_sectionread-only

One 21 CFR section: heading, full text, summary, firms cited most, sections cited alongside, observation topics, and the documents citing it (paged).

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

Parameters

citationstring, in pathrequired
e.g. 211.192 or 21 CFR 820.100.
limitinteger
Documents per page (default 50, max 200).
offsetinteger
Skip this many results (use next_offset from the previous page).

Example request

curl "https://fdaintel.ai/api/intel/v1/cfr/211.192?limit=10" \
  -H "Authorization: Bearer $FDA_INTEL_API_KEY"
Example response (200, shortened, made-up values)
200 OK · application/json
{
  "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
      }
    ]
  }
}

list_facetsFilter values and counts#

GET/api/intel/v1/facetsMCP tool: list_facetsread-only

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.

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

Parameters

None.

Example request

curl "https://fdaintel.ai/api/intel/v1/facets" \
  -H "Authorization: Bearer $FDA_INTEL_API_KEY"
Example response (200, shortened, made-up values)
200 OK · application/json
{
  "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
    }
  ]
}

catalog_statsCatalog statistics#

GET/api/intel/v1/statsMCP tool: catalog_statsread-only

Approximate size of the FDA Intel catalog: documents by type, observations, warning letters, firms, investigators and the date range.

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

Parameters

None.

Example request

curl "https://fdaintel.ai/api/intel/v1/stats" \
  -H "Authorization: Bearer $FDA_INTEL_API_KEY"
Example response (200, shortened, made-up values)
200 OK · application/json
{
  "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+"
    }
  ]
}