FDA Scraper for Drug Approvals, Recalls and Device Registries

What one FDA record holds: approvals, labels, recalls, device registries

Approvals. A Drugs@FDA record is an application: the application number carrying its NDA, ANDA or BLA prefix, the sponsor name, an array of products and an array of submissions. Each product has a product number, brand name, active ingredients as name and strength pairs, dosage form, route, marketing status and a therapeutic equivalence code, plus reference drug and reference standard flags. Each submission has a type of ORIG or SUPPL, a number, a status and status date, a review priority, a class code such as Labeling or Efficacy, property codes such as Orphan, and application documents pointing at the approval letter and label PDFs. The Orange Book repeats the product with its equivalence codes, application type A or N and the approval date.

Labeling. A label record is a Structured Product Label: a set id that survives every revision, an id and version for the specific submission, an effective time, and named sections rather than free prose - boxed warning, indications and usage, dosage and administration, contraindications, warnings and cautions, adverse reactions, drug interactions, clinical pharmacology, use in specific populations, how supplied, the medication guide and the principal display panel. Consumer products carry their own set: purpose, do not use, stop use, keep out of reach of children.

Recalls. An enforcement report carries a recall number, an event id grouping products in one action, a classification of Class I, II or III, a status, the recalling firm and its full address, the reason for recall, the product description, code info such as lot and expiry, product quantity, distribution pattern, and four dates: initiation, classification, report and termination.

Devices. A cleared 510(k) is a K number with applicant, address, country code, device name, three-letter product code, advisory committee, clearance type, dates received and decided, and a decision code. A PMA adds supplement number, type and reason. A unique device identifier record is the deepest: primary and secondary identifiers with their issuing agency, brand name, version or model, labeler DUNS, GMDN terms with code and definition, product codes carrying regulation number and device class, sterilization and MRI safety, and flags for prescription, over the counter, kit and single use.

Warning letters, Form 483 citations and FDA inspection outcomes

The enforcement record is the other half of the FDA picture. Warning letters sit in a filtered table with posted date, letter issue date, company name, issuing office, subject and links to the response and closeout letters; the table ran to roughly 3,700 rows in September 2026. Each letter page adds a MARCS-CMS number, a reference number such as 320-26-120, the delivery method, the recipient name and title, the ten-digit establishment identifier of the inspected site, the inspection dates and the cited parts of 21 CFR. Trade secrets are blanked in place as (b)(4), so the text is usable but gapped.

Inspection outcomes sit on the compliance dashboard, refreshed weekly and limited to final actions. Each row is a project area within an inspection, classified No Action Indicated, Voluntary Action Indicated or Official Action Indicated, so one visit can produce several classifications. Citations are published separately, keyed to the inspection and the establishment identifier, alongside Form 483 observations, compliance actions such as injunctions and seizures, and import refusals by country, port and product code.

Around the edges sit the sets people forget: complete response letters as OCR text of scanned PDFs, drug shortage entries with availability status, the national drug code directory and its NSDE package companion, UNII and substance records, tobacco product problem reports, cosmetic and food adverse events from CAERS, and animal drug events.