| # 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. | |
| This is a 10% sample. Get the full dataset (265,000+ pre-joined records) on Gumroad → https://mandiasdata.gumroad.com/l/fda-enforcement-linkage | |
| ## 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 | |