RubyIntelligence/fda-facility-compliance-intelligence

FDA Facility Compliance Intelligence

Version: 1.0.0 | Records: 132,080 | Price: $3,500 | Source: FDA (public domain)

Dataset Summary

The dataset's core signal — whether a facility's inspections escalated to a Warning Letter — tracks FDA's own severity classifications: facilities whose most recent inspection was OAI have escalated to a Warning Letter 65.7% of the time, versus 2.5% for NAI — a ~26× relationship you can reproduce directly from this file (GROUP BY most_recent_classification_code, averaging ever_escalated_to_wl).

Complete facility-level regulatory intelligence for every FDA-regulated establishment with an inspection on record — 132,080 facilities. Each row rolls up a facility's entire FDA history: inspection outcomes (OAI/VAI/NAI), Warning Letters, recalls, import refusals, citation analytics, 510(k) device clearances, and a computed escalation summary, condensed into a transparent 0–100 risk score. Built for pharma/medtech regulatory affairs and quality (RA/QA) teams, supplier-qualification and auditing groups, due-diligence analysts, and investors who need to know a facility's compliance posture at a glance.

Current through 2026 — the dataset includes FDA inspections from the most recent regulatory cycles (5,713 facilities inspected in 2026, 14,845 in 2025), not a historical snapshot. Quarterly refreshes keep it current.

What This Replaces

Comparable facility-level FDA regulatory intelligence from incumbent enterprise platforms requires annual contracts and enterprise procurement. This dataset delivers the same facility-level regulatory history and escalation analytics as a one-time, analysis-ready download — no contract, no seat licenses, no platform lock-in.

Source

All data derives from U.S. FDA public records:

• FDA Data Dashboard API — inspections, inspection citations, inspection classifications, compliance actions (Warning Letters / Injunctions / Seizures), and import refusals.
• openFDA — 510(k) device clearances, establishment registrations, device & drug recall enforcement reports, and device classification.
• All sources are U.S. Government works in the public domain (CC0). No PII is included (no patient, reporter, or individual-inspector identities).

The Premium Fields

The value of this dataset is the computed regulatory intelligence, not the raw counts:

• facility_risk_score (0–100) — a transparent composite of a facility's regulatory exposure. The full formula is published (see Methodology) so you can audit every point or recompute with your own weights from the underlying counts, which are all included.
• ever_escalated_to_wl / fastest_escalation_days — whether, and how quickly, this facility's inspections have historically escalated to Warning Letters. Directionality is enforced: an action only counts if it post-dates the inspection.
• repeat_citation_flag / most_cited_cfr / distinct_cfr_codes — citation analytics that surface chronic, repeated deficiencies (the same CFR cited across multiple inspections).
• Raw counts alongside every signal — oai_count, warning_letter_count, recall_count, import_refusal_count, etc. are all present so you are never locked into our thresholds.

Methodology

• Entity resolution. Records are joined on the FDA FEINumber (Facility Establishment Identifier), normalized to a trimmed string across every source. 510(k) clearances and import refusals carry an FEI directly.

• Escalation matching. For each inspection, the dataset finds compliance actions at the same FEI whose action date is strictly after the inspection end date, and keeps the nearest one (smallest positive day gap). Directionality is enforced in the join itself, so a Warning Letter that predates an inspection can never be counted as escalation. Escalation actions are Warning Letters (the canonical case) plus the stronger judicial actions Injunction and Seizure; the action type is retained so you can restrict to Warning-Letter-only.

• Risk score. Computed from each facility's history with a published formula:

  facility_risk_score = min(100,
      oai_count                              × 15
    + warning_letter_count                   × 20
    + recall_count                           × 10
    + min(import_refusal_count × 2, 20)           (import-refusal contribution capped at 20)
    + (repeat_citation_flag ? 10 : 0)
    + (most_recent_classification == OAI ? 15 : 0)
    + recency_factor)
  
  recency_factor (awarded only when the most recent inspection outcome was OAI or VAI):
    +10 if that inspection was within 1 year, +5 if within 3 years, +2 if within 5 years
    (evaluated as of the 2026-06-23 build date)
  

• Recall attribution. Recall enforcement reports carry no FEI, so recalls are matched to facilities by normalized firm name (uppercased, punctuation and common legal suffixes removed). The match is deliberately restricted to unambiguous 1:1 names — a normalized name owned by exactly one facility — to prevent a multi-site chain's recalls from being falsely attributed to every location that shares its name.

Validation

• Escalation signal validated (reproducible from this file). Grouping the shipped rows by most_recent_classification_code and averaging ever_escalated_to_wl, facilities whose most recent inspection was OAI (Official Action Indicated) have escalated to a Warning Letter at 65.7%, VAI at 6.0%, and NAI (No Action Indicated) at 2.5% — a monotone OAI > VAI > NAI ordering (~26× OAI-vs-NAI) confirming the computed escalation fields correlate correctly with inspection severity. (If escalation were a join artifact, NAI and OAI would escalate at similar rates.)
• Directionality enforced. Zero inspections have a negative inspection→action day gap; every Warning Letter counted as escalation post-dates its inspection.
• No orphaned escalations. Every recorded escalation action type exists in the source compliance-action data.
• Recall attribution restricted to unambiguous 1:1 facility-name matches to prevent false attribution (see Methodology).
• Completeness. Row counts reconcile exactly to the validated master tables.

Known Limitations

• Citation coverage. Inspection citations cover electronically generated, finalized inspections; some manually prepared Form 483s are not present in the FDA citations dataset.
• Recall attribution (~35%). Only recalls with an unambiguous 1:1 firm-name match are attributed; multi-site chains that share a normalized name are deliberately excluded to avoid false attribution, so recall counts are conservative (under- rather than over-counted).
• Inspector-level detail not included. The FDA citations API does not expose individual inspector identity, so inspector-level fields are out of scope for this version.
• Risk score is a heuristic. facility_risk_score is a transparent composite indicator, not an official FDA designation or prediction. All underlying counts are included so you can recompute it with your own weights.
• Warning Letter coverage. Warning Letters are attributed to facilities that appear in the inspection record; Warning Letters issued to firms without an inspection in the dataset are not rolled into a facility row.
• Null-by-design escalation timing. The fastest_escalation_days field is null by design for facilities that never escalated to a Warning Letter (ever_escalated_to_wl = false). This covers ~95% of facilities, reflecting that most FDA inspections do not lead to enforcement.
• Null-by-design citation field. The most_cited_cfr field is null for facilities with no posted citations on record (~64% of facilities). This is accurate — many inspections, particularly those classified NAI, result in no citations. All citation counts are included so this is transparent.

Field Definitions

Field	Type	Description
fei_number	string	FDA Facility Establishment Identifier (FEI) — the cross-source join key.
legal_name	string	Facility legal name, taken from its most recent inspection record.
city	string	Facility city (most recent inspection record).
state	string	Facility state/province (most recent inspection record).
country	string	Facility country (most recent inspection record).
product_types	list	Distinct FDA product areas inspected at this facility (e.g. Drugs, Devices, Foods).
total_inspections	integer	Count of distinct FDA inspections on record for this facility.
oai_count	integer	Inspections classified Official Action Indicated (OAI) — the most serious outcome.
vai_count	integer	Inspections classified Voluntary Action Indicated (VAI).
nai_count	integer	Inspections classified No Action Indicated (NAI).
most_recent_inspection_date	date	End date of the facility's most recent inspection.
most_recent_classification	string	Classification of the most recent inspection (full text).
most_recent_classification_code	string	Classification code of the most recent inspection (NAI/VAI/OAI).
warning_letter_count	integer	Count of Warning Letter compliance actions issued to this FEI.
recall_count	integer	Count of device + drug recalls attributed to this facility. Recalls carry no FEI, so they are matched by unambiguous 1:1 normalized firm name (see Methodology).
import_refusal_count	integer	Count of FDA import refusals recorded against this FEI.
total_citations	integer	Total inspection citations (483 observations) recorded across all inspections.
distinct_cfr_codes	integer	Number of distinct CFR codes cited across the facility's inspections.
repeat_citation_flag	boolean	True if the same CFR code was cited across 2+ distinct inspections.
most_cited_cfr	string	The CFR code cited across the most distinct inspections at this facility. Null for facilities with no posted citations on record (~64% of facilities).
ever_escalated_to_wl	boolean	True if any inspection at this facility was followed by a Warning Letter (or stronger).
fastest_escalation_days	integer	Shortest observed gap (days) from an inspection end to a subsequent Warning Letter; null by design when the facility never escalated (ever_escalated_to_wl = false), which covers ~95% of facilities.
has_510k_clearance	boolean	True if the facility holds at least one 510(k) device clearance.
count_510k	integer	Number of 510(k) device clearances linked to this facility's FEI.
facility_risk_score	float	Composite regulatory-risk score, 0–100 (higher = more regulatory exposure). Heuristic, not an official FDA designation. Formula: min(100, oai_count15 + warning_letter_count20 + recall_count10 + min(import_refusal_count2,20) + repeat_citation_flag*10 + (recent OAI)*15 + recency_factor).

Update Cadence

Quarterly, tracking FDA Data Dashboard refreshes.

License

Derived entirely from U.S. federal government public records (FDA Data Dashboard, openFDA), which are in the public domain. This structured, enriched version is provided under CC BY 4.0 — attribution required.

How to Access the Full Dataset

Full dataset available at Ruby Intelligence on Gumroad.