# FDA Enforcement Linkage Dataset

A pre-joined, analysis-ready dataset connecting FDA inspection outcomes to enforcement actions, regulatory citations, and product recalls — covering **265,000+ inspections** across **129,000+ facilities** from 2008 to present.

## Why This Dataset Exists

FDA publishes inspection, citation, compliance, and recall data across 4-5 separate databases with no common key. Researchers, compliance teams, and analysts must manually cross-reference these systems to answer basic questions like:

- What happened after a facility failed an inspection?
- How long does FDA take to issue a Warning Letter after an OAI classification?
- Which CFR violations most frequently lead to recalls?

This dataset joins those sources into a single flat file.

## Schema

| Column | Type | Description |
|--------|------|-------------|
| `inspection_id` | int | DDAPI inspection identifier |
| `fei_number` | str | FDA Establishment Identifier |
| `firm_name` | str | Inspected facility name |
| `inspection_start_date` | date | Inspection start |
| `inspection_end_date` | date | Inspection end |
| `classification` | str | NAI / VAI / OAI |
| `product_category` | str | Drugs, Food/Cosmetics, Devices, Veterinary, etc. |
| `citation_count` | int | Number of CFR citations for this inspection |
| `cfr_violations` | str | Semicolon-delimited CFR references (e.g., "21 CFR 211.68(a)") |
| `citation_texts` | str | Full citation text descriptions |
| `compliance_action_type` | str | Warning Letter / Injunction / Seizure (null if none) |
| `compliance_action_date` | date | Date enforcement action was taken |
| `days_to_action` | int | Days between inspection end and enforcement action |
| `related_drug_recall_numbers` | str | Drug recall numbers within ±6mo–2yr of inspection |
| `related_drug_recall_statuses` | str | Status of related drug recalls |
| `related_drug_recall_count` | int | Count of related drug recalls |
| `related_device_recall_numbers` | str | Device recall numbers linked by firm + timing |
| `related_device_recall_count` | int | Count of related device recalls |

## Coverage

- **265,000+** inspection records
- **129,000+** unique facilities (by FEI number)
- **10,000+** Official Action Indicated (OAI) inspections
- **8,300+** inspections linked to compliance actions
- **4,000+** inspections linked to recalls
- **Date range**: October 2008 – present
- **Update frequency**: Quarterly

## Sources

All data derived from public FDA databases:
- [DDAPI Inspections & Classifications](https://datadashboard.fda.gov/ora/cd/inspections.htm)
- [DDAPI Inspection Citations](https://datadashboard.fda.gov/ora/cd/citations.htm)
- [DDAPI Compliance Actions](https://datadashboard.fda.gov/ora/cd/complianceactions.htm)
- [OpenFDA Drug Recalls](https://open.fda.gov/apis/drug/enforcement/)
- [OpenFDA Device Recalls](https://open.fda.gov/apis/device/enforcement/)

## Methodology

- Inspections linked to citations via `inspection_id`
- Compliance actions linked to inspections via `fei_number` + time proximity (action within 2 years of inspection end)
- Drug recalls linked via normalized firm name + time proximity (±6 months to 2 years)
- Device recalls linked via normalized firm name + time proximity (±6 months to 2 years)

## Sample

The `_sample` file contains a random 10% subset for evaluation purposes.

## License

Derived from U.S. government public data. The underlying data is in the public domain. This compiled and linked dataset is provided as-is.

## Purchase

For the full dataset: https://mandiasdata.gumroad.com/l/fda-enforcement-linkage