tensorust/fda-warning-letters-sample

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