---
license: cc0-1.0
task_categories:
  - text-classification
  - tabular-classification
  - tabular-regression
language:
  - en
tags:
  - federal
  - government
  - regulatory
  - united-states
  - public-data
  - cc0
  - u-s-food-and-drug-administration
  - fda
  - warning-letter
  - cder
pretty_name: "FDA Warning Letters"
size_categories:
  - unknown
homepage: https://api.ai-analytics.org/datasets/fda-warning-letters
---

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

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

```bash
# 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](https://www.law.cornell.edu/uscode/text/5/105) / [17 USC 105](https://www.law.cornell.edu/uscode/text/17/105).
- **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

```bibtex
@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.}
}
```

## Related

- [Full data catalog (100 datasets)](https://api.ai-analytics.org/datasets/)
- [Unified compliance screening (30+ enforcement lists)](https://api.ai-analytics.org/api/v1/screening/all)
- [Cross-vertical entity timeline](https://api.ai-analytics.org/api/v1/entity/AAPL/timeline)
- [OpenAPI 3.1 spec](https://api.ai-analytics.org/openapi.json)
- [llms.txt for AI agents](https://api.ai-analytics.org/llms.txt)

---
*Maintained by [AI Analytics](https://ai-analytics.org). Data is CC0; please cite the upstream agency.*