license: other
license_name: tensorust-sample-license
license_link: https://tensorust.com/datasets/fda-warning-letters/
pretty_name: FDA Warning Letter Ledger (free sample)
language:
- en
tags:
- tensorust
- sample
- compliance-and-sanctions
- government-data
- finance
size_categories:
- n<1K
configs:
- config_name: sample
data_files:
- split: train
path: sample.csv
- config_name: summary
data_files:
- split: train
path: summary_by_violation_categories.csv
FDA Warning Letter Ledger: free sample (Tensorust LLC)
Every FDA warning letter in the public index, by company and violation type, with repeat recipients flagged.
Headline: A warning letter is FDA's formal notice that a company is in significant violation and must fix it, but FDA's index lists letters one at a time, with no count of who keeps getting them.
This repository is a free teaser, not the dataset. It holds 25 example rows and a summary table with no names in it. The full file has 3,722 rows and is sold by Tensorust LLC: https://tensorust.com/datasets/fda-warning-letters/.
Files here
| file | what it is |
|---|---|
sample.csv |
25 rows of the full file (the same sample shown on tensorust.com) |
summary_by_violation_categories.csv |
row counts by violation categories across the full file, no entity names (groups with fewer than 3 rows are folded into "Other") |
Summary by violation categories (largest groups)
| Violation categories | rows |
|---|---|
| Unapproved or misbranded drugs; Adulterated; Tobacco | 1,208 |
| Unapproved or misbranded drugs | 511 |
| CGMP drugs; CGMP other or devices; Adulterated | 446 |
| Food safety (FSVP, HACCP, CGMP food) | 338 |
| CGMP other or devices; Adulterated; Food safety (FSVP, HACCP, CGMP food) | 204 |
| Unapproved or misbranded drugs; Internet / COVID claims | 160 |
| (blank) | 131 |
| CGMP other or devices; Adulterated; Medical devices | 101 |
| CGMP drugs; CGMP other or devices; Unapproved or misbranded drugs; Adulterated | 66 |
| Adulterated; Compounding / outsourcing | 59 |
| Adulterated; Food safety (FSVP, HACCP, CGMP food) | 48 |
| Adulterated; Medical devices | 45 |
| TOTAL | 3,722 |
Full table: summary_by_violation_categories.csv.
What the full file has
- 3,722 rows
- Key fields: letter_date, posted_date, company, company_key, issuing_office, subject, violation_categories, response_letter, closeout_letter, letters_to_company
- Parquet and CSV, a README with sources, method and limits, and the build script
- Free 25-row sample (no personal contact data)
Coverage: 3,722 letters to 3,542 companies; the index FDA keeps online. FDA index read Nov 6, 2026.
Columns in the full file
| column | meaning |
|---|---|
letter_date |
Date on the warning letter |
posted_date |
Date FDA posted it |
company |
Recipient company |
company_key |
Ontology organization key |
issuing_office |
FDA center or office that issued it |
subject |
Subject line (violation type) as FDA lists it |
violation_categories |
Tensorust categories derived from the subject |
response_letter |
FDA posted a response letter |
closeout_letter |
FDA posted a close-out letter (issues resolved) |
letters_to_company |
Letters to the same company in the index |
first_letter |
Earliest letter to the company in the index |
latest_letter |
Latest letter to the company |
repeat_recipient |
Two or more letters to the same company |
fed_uei |
UEI of a matching federal award recipient |
fed_recipient_name |
Matching USAspending recipient |
fed_obligated_fy25_plus |
Its obligations FY2025 onward (USD) |
fed_top_agency |
Top awarding agency |
in_ontology |
Company key exists in the Tensorust ontology |
letter_url |
The letter on fda.gov |
Get the full file
| tier | price | includes |
|---|---|---|
| Warning letter file | $900 | All 3,722 warning letters in FDA's index with violation categories, close-out status, repeat-recipient counts and links. |
| Weekly warning letter feed | $6,000 a year | New letters each week as FDA posts them (it posts on Tuesdays), categorized, with repeat recipients flagged. Up to 5 users. |
| Quality and diligence license | $18,000 a year | The weekly feed firm-wide, screening of your supplier or target list, and FDA 483 and import alert joins on request. |
Email mattbusel@tensorust.com with the tier and a billing contact, and we will send a proper invoice (ACH or card). The file is delivered once the invoice is paid. Details and the live sample: https://tensorust.com/datasets/fda-warning-letters/. All datasets: https://tensorust.com/datasets/
Method and limits
The table behind FDA's warning letter page is read in four requests, two seconds apart. Letters to individual physicians and clinical investigators are removed. Company names are normalized with the ontology key to count repeat recipients and to join USAspending recipients. Categories are keyword rules on FDA's subject line.
Not FDA Form 483 observations or import alerts, and not every historical letter: it is the index FDA keeps online. A close-out flag is only set when FDA has posted one. Not regulatory advice. Letters to individual physicians and investigators are excluded.
Sources
- FDA warning letters index: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/compliance-actions-and-activities/warning-letters
- USAspending.gov recipients via the Tensorust ontology: https://www.usaspending.gov/
License
The sample and summary here are free to view, analyze and cite with attribution to "Tensorust LLC, https://tensorust.com/datasets/fda-warning-letters/". The full dataset is licensed separately per tier. No resale or redistribution of Tensorust data without a written license.
Tensorust LLC, Tuckahoe NY. mattbusel@tensorust.com | https://tensorust.com