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AGENTIC Data Mining
● Public TOOL fda.warning_letters LAST SYNC 2026-07-19T11:01:25Z

FDA warning letters

The FDA's full warning-letter enforcement corpus, direct from fda.gov's own index -- not limited to any one product category. Covers pharmaceutical and API manufacturers, telehealth prescribers, food producers, medical device makers, and clinical investigators alike. Search which companies are under FDA action, for what violation, and whether it's resolved or still open. Every letter is enriched with resolution status, cited products, a plain-language violation summary, cited regulations, and days-open. This is a broad enforcement dataset, not a peptide-specific one -- of the 964 letters tracked, a minority (roughly 71) map to peptide vendors; those are also surfaced as a compliance flag inside commerce.peptides.

Records

964

Warning letters, all FDA-regulated industries

History

2021–2026

2021-01-04 through 2026-07-08

Resolved

Mixed

is_resolved + closeout_date on every letter

Freshness

Daily

JSON · Public · included in subscription

Live-verified 2026-07-19: 964 letters synced, 2021-01-04 through 2026-07-08. This vertical syncs with skip_coverage=true under a hyphenated slug (fda.warning-letters) in the coverage API -- catalog.json itself has no entry for this dataset.

Query parameters

companystring

Company name, partial match

productstring

Product cited in the letter, partial match

categorystring

Violation category, exact match -- cgmp | data_integrity | unapproved_drug | labeling

is_resolvedboolean

true for closed-out letters, false for active/open enforcement

cited_regulationstring

Cited CFR regulation, partial match

issued_after / issued_beforedate / date

Posted-date window (YYYY-MM-DD). Default sort is newest first.

limitnumber

Max records per response (default 25, max 50)

Shared parameters shown; the tool's full input schema is served by the MCP server at connection time.

Example calls

Request · fda.warning_letters 
{
  "tool": "fda.warning_letters",
  "params": {
    "category": "data_integrity",
    "is_resolved": false,
    "issued_after": "2025-07-15",
    "limit": 25
  }
}

Unresolved CGMP data-integrity letters posted in the last 12 months.

Request · fda.warning_letters 
{
  "tool": "fda.warning_letters",
  "params": {
    "product": "semaglutide",
    "limit": 25
  }
}

All warning letters citing a specific product.

Try in playground

Schema

Field Type Description
company_namestringCompany the letter was issued to
subjectstringFDA's own subject line for the letter
issue_date / posted_datedate / dateLetter issue date and fda.gov posting date; queries sort/filter on posted_date
letter_urlstringLink to the source letter on fda.gov -- cite this
issuing_officestringFDA office/center that issued the letter (e.g. CDER, CFSAN)
vendor_domainstringCompany's web domain, when resolvable -- the join key commerce.peptides uses
letter_refstringFDA's own letter reference/case number
cited_compoundsstringCompound names extracted from letter text, when present
is_resolvedbooleanWhether FDA has closed out the letter
closeout_datedateDate the letter was closed out, null while open
products_citedstringProducts named in the letter body -- filterable
violation_summarystringPlain-language summary of the cited violation(s)
cited_regulationsstringCFR regulations cited in the letter -- filterable
days_opennumberDays between issue and closeout (or today, if still open)
categorystringViolation category -- cgmp | data_integrity | unapproved_drug | labeling

Sample record

Sample · fda.warning_letters 
{
  "company_name": "Example Pharma Manufacturing LLC",
  "subject": "CGMP/Data Integrity",
  "issue_date": "2026-05-04",
  "posted_date": "2026-05-12",
  "letter_url": "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/example-pharma-manufacturing-llc-123456-05042026",
  "issuing_office": "CDER Office of Manufacturing Quality",
  "vendor_domain": "examplepharma.com",
  "letter_ref": "MARCS-CMS 123456",
  "cited_compounds": "Semaglutide",
  "is_resolved": false,
  "closeout_date": null,
  "products_cited": "Semaglutide injection, compounded",
  "violation_summary": "Failure to establish adequate written procedures for production and process controls; data integrity deficiencies in batch records.",
  "cited_regulations": "21 CFR 211.100(a); 21 CFR 211.192",
  "days_open": 71,
  "category": "cgmp"
}

Use it for

  • Which companies are currently under active (unresolved) FDA enforcement, and for what
  • Regulatory-risk screening on a company, product, or manufacturing partner before a deal or supplier decision
  • Category-level enforcement trend tracking (cGMP vs. data integrity vs. unapproved-drug vs. labeling)

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