Every formal FDA Warning Letter the FDA has posted since ~2005 — 1,725 letters issued by the various FDA centers (CDER, CFSAN, CTP, CDRH, CVM, CBER) to companies whose inspections found significant regulatory violations. Each letter is the agency's official 'you must fix this or face enforcement.' Warning Letters are the leading indicator for FDA enforcement — they precede consent decrees, seizures, and injunctions. Pairs with fda_recalls, fda_510k, and fda_adverse_events for the full FDA regulatory picture.

Live API

This dataset is served via a live REST API at api.ai-analytics.org. The card you're reading exists so HuggingFace's index can route AI agents + researchers to the canonical source.

API endpoint: https://api.ai-analytics.org/api/v1/fda/warning-letters/recent
Dataset landing page: https://api.ai-analytics.org/datasets/fda-warning-letters
DataCatalog (JSON-LD): https://api.ai-analytics.org/.well-known/dataset.json
DCAT-US (data.gov-compatible): https://api.ai-analytics.org/data.json

Quick start

# Recent records (JSON)
curl 'https://api.ai-analytics.org/api/v1/fda/warning-letters/recent?limit=10'

# Browse on the web
open 'https://api.ai-analytics.org/datasets/fda-warning-letters'

MCP (Model Context Protocol)

This dataset is also accessible via MCP at https://api.ai-analytics.org/mcp — Claude, ChatGPT, and other MCP-compatible agents can call it directly.

Source

Agency: U.S. Food and Drug Administration
Primary source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/compliance-actions-and-activities/warning-letters
License: CC0 1.0 Universal (derived data). Underlying federal works are US public domain under 5 USC 105 / 17 USC 105.
Update cadence: Per agency (most refresh daily via Cloudflare Cron Trigger)

Keywords

FDA, Warning Letter, CDER, CFSAN, CTP, CDRH, tobacco, cGMP, QSR, enforcement, compliance

Citation

@misc{ai_analytics_fda_warning_letters_2026,
  title  = {{name}},
  author = {AI Analytics},
  year   = {2026},
  url    = {https://api.ai-analytics.org/datasets/fda-warning-letters},
  note   = {Derived from U.S. Food and Drug Administration. License: CC0 1.0.}
}

Maintained by AI Analytics. Data is CC0; please cite the upstream agency.

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FDA Warning Letters (1,725 enforcement letters across drugs, devices, food, tobacco)