REST reference

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.

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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.

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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.

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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.

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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.

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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.

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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.

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Find FDA investigators by name (fuzzy, any variant). Returns ids, document and site counts, first/last seen.

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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.

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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.

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

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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.

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

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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.

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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.

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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.

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Search FDA inspections across all firms by name, FEI, classification (NAI/VAI/OAI), project area, product type, country, state or date range. Newest first.

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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.

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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.

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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.

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FDA drug shortage list: generic name, company, presentation, status (Current, To Be Discontinued, Resolved), availability, reason and dates.

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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).

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Device 510(k) clearances by K number, device / applicant words, applicant, product code or decision date range, with the device class and regulation number.

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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.

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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.

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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.

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Check a person or firm name against FDA's debarment list and the clinical investigator disqualification list (name match only).

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