Tools reference
FDA public data
Inspections and citations, warning-letter status, import alerts, recalls, drug shortages, registrations, 510(k), PMA, NDC, drug applications and debarment. Each tool is an MCP tool and a REST endpoint with the same name and parameters.
find_facilityFind a facility#
GET/api/intel/v1/call/find_facilityMCP tool: find_facilityread-only
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.
Parameters
NameDescription
qstring
Facility or firm name, e.g. 'Aurobindo Unit VII'.
feistring
FDA Establishment Identifier (FEI) of the facility, digits only.
countrystring
Country filter, e.g. India.
limitinteger
Max results (default 20, max 50).
Example request
curl "https://fdaintel.ai/api/intel/v1/call/find_facility?q=Example+Pharma+Unit+II&country=India" \
-H "Authorization: Bearer $FDA_INTEL_API_KEY"Example response (200, shortened, made-up values)
200 OK · application/json
{
"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."
}facility_signalFacility signal#
GET/api/intel/v1/call/facility_signalMCP tool: facility_signalread-only
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.
Parameters
NameDescription
feistringrequired
FDA Establishment Identifier (FEI) of the facility, digits only.
Example request
curl "https://fdaintel.ai/api/intel/v1/call/facility_signal?fei=3001234567" \
-H "Authorization: Bearer $FDA_INTEL_API_KEY"Example response (200, shortened, made-up values)
200 OK · application/json
{
"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."
}
]
}
}inspection_historyInspection history with citations#
GET/api/intel/v1/call/inspection_historyMCP tool: inspection_historyread-only
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.
Parameters
NameDescription
feistringrequired
FDA Establishment Identifier (FEI) of the facility, digits only.
include_citationsboolean
Include citations (default true).
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/call/inspection_history?fei=3001234567&limit=10" \
-H "Authorization: Bearer $FDA_INTEL_API_KEY"Example response (200, shortened, made-up values)
200 OK · application/json
{
"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 …"
}
]
}
]
}search_inspectionsSearch FDA inspections#
GET/api/intel/v1/call/search_inspectionsMCP tool: search_inspectionsread-only
Search FDA inspections across all firms by name, FEI, classification (NAI/VAI/OAI), project area, product type, country, state or date range. Newest first.
Parameters
NameDescription
qstring
Firm name words.
feistring
FDA Establishment Identifier (FEI) of the facility, digits only.
classificationstring
NAI, VAI or OAI. One of:
NAI, VAI, OAI.project_areastring
Project area contains, e.g. 'Drug Quality Assurance'.
product_typestring
Product type contains, e.g. Drugs, Devices.
countrystring
Country.
statestring
US state code.
date_fromstring
Earliest date, inclusive: 2023, 2023-06 or 2023-06-15.
date_tostring
Latest date, inclusive: 2024, 2024-03 or 2024-03-31.
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/call/search_inspections?classification=OAI&product_type=Drugs&country=India&date_from=2024" \
-H "Authorization: Bearer $FDA_INTEL_API_KEY"Example response (200, shortened, made-up values)
200 OK · application/json
{
"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
}
]
}search_recallsSearch recalls#
GET/api/intel/v1/call/search_recallsMCP tool: search_recallsread-only
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.
Parameters
NameDescription
firmstring
Recalling firm name words.
qstring
Words in the product description or reason, e.g. 'sterility assurance'.
feistring
FDA Establishment Identifier (FEI) of the facility, digits only.
centerstring
drug, device or food. One of:
drug, device, food.classificationstring
Class I, Class II or Class III.
statusstring
Ongoing, Completed or Terminated.
recall_numberstring
e.g. D-0123-2024.
date_fromstring
Earliest date, inclusive: 2023, 2023-06 or 2023-06-15.
date_tostring
Latest date, inclusive: 2024, 2024-03 or 2024-03-31.
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/call/search_recalls?firm=Example+Pharma¢er=drug&date_from=2023" \
-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": [
{
"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"
]
}
]
}search_import_alertsImport alerts#
GET/api/intel/v1/call/search_import_alertsMCP tool: search_import_alertsread-only
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.
Parameters
NameDescription
alert_nostring
e.g. 66-40.
firmstring
Firm name words.
feistring
FDA Establishment Identifier (FEI) of the facility, digits only.
countrystring
Country.
liststring
red (detention without examination), yellow or green (exempted). One of:
red, yellow, green.qstring
Words in an alert title.
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/call/search_import_alerts?fei=3001234567" \
-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": [
{
"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"
}
]
}warning_letter_statusWarning-letter status#
GET/api/intel/v1/call/warning_letter_statusMCP tool: warning_letter_statusread-only
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.
Parameters
NameDescription
companystring
Company name words.
marcs_cmsstring
MARCS-CMS number.
issuing_officestring
Issuing office contains.
subjectstring
Subject contains, e.g. CGMP.
closed_outboolean
Only letters with (true) or without (false) a posted close-out.
date_fromstring
Earliest date, inclusive: 2023, 2023-06 or 2023-06-15.
date_tostring
Latest date, inclusive: 2024, 2024-03 or 2024-03-31.
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/call/warning_letter_status?company=Example+Pharma&date_from=2022" \
-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": [
{
"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
}
}
]
}
]
}drug_shortagesDrug shortages#
GET/api/intel/v1/call/drug_shortagesMCP tool: drug_shortagesread-only
FDA drug shortage list: generic name, company, presentation, status (Current, To Be Discontinued, Resolved), availability, reason and dates.
Parameters
NameDescription
qstring
Drug name words, e.g. 'cisplatin'.
companystring
Company name words.
statusstring
Current, To Be Discontinued or Resolved.
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/call/drug_shortages?q=cisplatin&status=Current" \
-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": [
{
"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
}
]
}search_registrationsEstablishment registrations#
GET/api/intel/v1/call/search_registrationsMCP tool: search_registrationsread-only
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).
Parameters
NameDescription
kindstring
drug (default) or device. One of:
drug, device.qstring
Establishment or owner name words.
feistring
FDA Establishment Identifier (FEI) of the facility, digits only.
countrystring
Country (drug) or 2-letter ISO code (device).
product_codestring
Device product code, e.g. FRN (device only).
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/call/search_registrations?kind=drug&fei=3001234567" \
-H "Authorization: Bearer $FDA_INTEL_API_KEY"Example response (200, shortened, made-up values)
200 OK · application/json
{
"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
}
]
}lookup_510k510(k) clearances#
GET/api/intel/v1/call/lookup_510kMCP tool: lookup_510kread-only
Device 510(k) clearances by K number, device / applicant words, applicant, product code or decision date range, with the device class and regulation number.
Parameters
NameDescription
k_numberstring
e.g. K213456.
qstring
Device or applicant words.
applicantstring
Applicant name words.
product_codestring
Product code, e.g. DQY.
date_fromstring
Earliest date, inclusive: 2023, 2023-06 or 2023-06-15.
date_tostring
Latest date, inclusive: 2024, 2024-03 or 2024-03-31.
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/call/lookup_510k?k_number=K000001" \
-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": [
{
"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"
}
]
}lookup_pmaPMA approvals#
GET/api/intel/v1/call/lookup_pmaMCP tool: lookup_pmaread-only
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.
Parameters
NameDescription
pma_numberstring
e.g. P200012.
qstring
Trade name, generic name or applicant words.
product_codestring
Product code.
include_supplementsboolean
Include PMA supplements (default false).
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/call/lookup_pma?q=Example+stent" \
-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": [
{
"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"
}
]
}lookup_ndcNDC directory#
GET/api/intel/v1/call/lookup_ndcMCP tool: lookup_ndcread-only
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.
Parameters
NameDescription
ndcstring
Product NDC, e.g. 0002-1433.
qstring
Brand or generic name words.
labelerstring
Labeler name words.
application_numberstring
e.g. NDA021436.
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/call/lookup_ndc?q=examplomab" \
-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": [
{
"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": []
}
]
}lookup_drug_applicationDrug applications (Drugs@FDA)#
GET/api/intel/v1/call/lookup_drug_applicationMCP tool: lookup_drug_applicationread-only
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.
Parameters
NameDescription
application_numberstring
e.g. NDA021436 or ANDA076543.
qstring
Brand name or active ingredient.
sponsorstring
Sponsor name 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/call/lookup_drug_application?application_number=ANDA000001" \
-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": [
{
"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"
}
]
}
]
}check_debarmentDebarment check#
GET/api/intel/v1/call/check_debarmentMCP tool: check_debarmentread-only
Check a person or firm name against FDA's debarment list and the clinical investigator disqualification list (name match only).
Parameters
NameDescription
qstringrequired
Person or firm name.
Example request
curl "https://fdaintel.ai/api/intel/v1/call/check_debarment?q=John+Example" \
-H "Authorization: Bearer $FDA_INTEL_API_KEY"Example response (200, shortened, made-up values)
200 OK · application/json
{
"debarments": [],
"clinical_investigator_disqualifications": [],
"note": "No match on the FDA debarment list or the clinical investigator disqualification list."
}