# 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_count*15 + warning_letter_count*20 + recall_count*10 + min(import_refusal_count*2,20) + 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](https://rubyintelligence.gumroad.com/l/izpoe).