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
- DDAPI Inspection Citations
- DDAPI Compliance Actions
- OpenFDA Drug Recalls
- OpenFDA Device Recalls
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