Upload 2 files

README.md

@@ -1,3 +1,74 @@
----
-license: cc-by-4.0
----
+# 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.
+
+## Contact
+
+For the full dataset, custom queries, or API access, contact: [your email]

fda_enforcement_linkage_sample_20260225.parquet

@@ -0,0 +1,3 @@
+version https://git-lfs.github.com/spec/v1
+oid sha256:749c509d94209150e3c50d5d47f322a73d79434393348416fb1419841c726374
+size 1027972