wapplewhite4/fda-facility-risk-scores

FDA Facility Risk Scores

Composite risk scores for 129,000+ FDA-regulated facilities based on inspection history, enforcement outcomes, regulatory citations, compliance actions, and product recalls. Updated quarterly.

Why This Dataset Exists

Assessing the regulatory risk of a pharmaceutical or food manufacturing facility currently requires manually querying multiple FDA databases, tallying inspection outcomes, and tracking enforcement history over time. This dataset computes it all into a single row per facility with a 0–100 risk score.

Built for supply chain due diligence, vendor qualification, and portfolio risk monitoring.

Schema

Column	Type	Description
fei_number	str	FDA Establishment Identifier (unique per facility)
firm_name	str	Facility name
product_categories	str	Drugs, Food/Cosmetics, Devices, Veterinary, etc.
total_inspections	int	Total FDA inspections on record
oai_count	int	Official Action Indicated — most severe classification
vai_count	int	Voluntary Action Indicated — moderate findings
nai_count	int	No Action Indicated — clean inspection
oai_rate	float	Proportion of inspections resulting in OAI
vai_rate	float	Proportion resulting in VAI
first_inspection	date	Earliest inspection on record
last_inspection	date	Most recent inspection
history_days	int	Days between first and last inspection
last_classification	str	Most recent inspection outcome
recent_oai_count	int	OAI count in the last 3 years
recent_inspection_count	int	Total inspections in the last 3 years
recent_oai_rate	float	OAI rate over last 3 years
trend_direction	str	worsening / stable / improving / no_recent_data
total_citations	int	Specific CFR violations cited
unique_cfr_violations	int	Distinct CFR sections violated
all_cfr_violations	str	Semicolon-delimited CFR references
total_compliance_actions	int	Warning Letters + Injunctions + Seizures
warning_letter_count	int	Warning Letters issued
injunction_count	int	Court injunctions
seizure_count	int	Product seizures
drug_recall_count	int	Associated drug recalls
risk_score	float	Composite score 0–100 (higher = more risk)

Risk Score Methodology

The composite risk score (0–100) weights:

• OAI rate (0–40 points) — history of serious inspection failures
• Compliance actions (0–25 points) — Warning Letters, Injunctions, Seizures
• Citations (0–15 points) — specific regulatory violations
• Recalls (0–10 points) — associated product recalls
• Recency (0–10 points) — OAI in the last year with few inspections

Coverage

• 129,000+ unique facilities
• 7,700+ with at least one OAI
• 7,000+ with compliance actions
• Date range: 2008 – present
• Update frequency: Quarterly

Sample

This is a 10% random sample. The full dataset (129,000+ facilities) is available for purchase — contact details below.

Sources

All data derived from public FDA databases: DDAPI Inspections & Classifications, DDAPI Citations, DDAPI Compliance Actions, and OpenFDA Drug Enforcement.

License

Derived from U.S. government public data. This compiled and scored dataset is provided as-is.

Contact

For the full dataset, custom queries, or API access, contact: wapplewhite4@gmail.com