| # FDA Warning Letter Escalation Dataset |
| **Version:** 1.0.0 | **Records:** 14,810 | **Price:** $2,000 | **Source:** FDA (public domain) |
|
|
| ## Dataset Summary |
| **The dataset's core signal — whether an inspection escalated to a Warning Letter — is validated against FDA's own severity classifications: OAI inspections escalate at 64% versus 1.7% for NAI, a 39× relationship that confirms the data reflects real regulatory behavior.** |
|
|
| The 14,810 inspections that escalated to enforcement — every inspection followed by a Warning Letter, Injunction, or Seizure — with full citation context and exact timing (days from inspection to action, and 90/180/365-day windows). Pure signal: the dataset of what FDA findings actually precede enforcement. Built for RA/QA risk modelling and enforcement-pattern analysis. |
|
|
| Current through 2026 — the dataset includes FDA inspections from the most recent regulatory cycles |
| (covering 5,713 facilities inspected in 2026 and 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 enforcement-escalation intelligence 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 premium fields are the **escalation linkage** — computed by matching each inspection to the |
| nearest subsequent enforcement action at the same facility: |
|
|
| - **`days_inspection_to_warning_letter`** — exact day gap from the inspection's end to the nearest |
| subsequent Warning Letter / Injunction / Seizure. Always positive (directionality enforced); |
| null if no action followed. The raw day count is provided so you can set your own thresholds. |
| - **`escalated_within_90d` / `_180d` / `_365d` / `escalated_ever`** — convenience booleans derived |
| from the day gap. |
| - **`escalated_warning_letter_action_type`** — which action followed (Warning Letter, Injunction, or |
| Seizure), so you can restrict to Warning-Letter-only escalation if you wish. |
| - **`citation_count` / `cfr_codes_cited` / `citation_descriptions`** — the inspection's full citation |
| context, so the finding and its consequence sit in one row. |
| |
| ## 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.** OAI (Official Action Indicated) inspections escalate to Warning |
| Letters at **64%** versus **1.7%** for NAI (No Action Indicated) inspections — a monotone, |
| ~39× relationship 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. |
| - **Escalation timing always populated here.** Because this dataset is filtered to inspections that |
| escalated, `days_inspection_to_warning_letter` and `escalated_warning_letter_action_type` are |
| populated on every row. In the full inspection dataset these fields are null by design for the |
| large majority of inspections that never escalate, reflecting that most FDA inspections do not |
| lead to enforcement. |
| - **Null-by-design citation context.** The citation fields (`citation_count`, `cfr_codes_cited`, |
| `citation_descriptions`) can be empty/null for escalated inspections with no posted citations on |
| record. This is accurate — some inspections result in enforcement without posted 483 citations, |
| and many inspections classified NAI carry no citations at all. The `posted_citations` flag is |
| included so this is transparent. |
| |
| ## Field Definitions |
| | Field | Type | Description | |
| |-------|------|-------------| |
| | `fei_number` | string | FDA Facility Establishment Identifier (FEI) of the inspected facility. | |
| | `inspection_id` | string | FDA Data Dashboard inspection identifier (not unique per row — an inspection may span multiple product/program rows). | |
| | `legal_name` | string | Inspected facility legal name. | |
| | `inspection_end_date` | date | Date the inspection ended. | |
| | `fiscal_year` | string | FDA fiscal year of the inspection. | |
| | `classification` | string | Inspection outcome classification (full text). | |
| | `classification_code` | string | Inspection outcome code: NAI (No Action), VAI (Voluntary Action), OAI (Official Action). | |
| | `project_area` | string | FDA project area for the inspection. | |
| | `product_type` | string | Product area covered by this inspection row (Drugs, Devices, Foods, etc.). | |
| | `posted_citations` | string | FDA flag indicating whether citations were posted for this inspection. | |
| | `city` | string | Facility city. | |
| | `state` | string | Facility state/province. | |
| | `state_code` | string | Facility state code. | |
| | `country` | string | Facility country. | |
| | `firm_profile` | string | URL to the facility's FDA FirmProfile page. | |
| | `citation_count` | integer | Number of citations (483 observations) recorded for this inspection. | |
| | `cfr_codes_cited` | list<string> | Distinct CFR codes cited in this inspection. | |
| | `citation_descriptions` | list<string> | Short descriptions of the citations issued in this inspection. | |
| | `days_inspection_to_warning_letter` | integer | Days from this inspection's end to the NEAREST subsequent escalation action at the same facility (Warning Letter / Injunction / Seizure). Populated on every row in this escalation-filtered dataset (null by design only in the full inspection dataset, when no escalation followed). Always positive — directionality is enforced (the action must post-date the inspection). | |
| | `escalated_warning_letter_action_type` | string | ActionType of the nearest subsequent escalation (Warning Letter, Injunction, or Seizure); populated on every row in this escalation-filtered dataset. | |
| | `escalated_within_90d` | boolean | True if an escalation action followed within 90 days of the inspection. | |
| | `escalated_within_180d` | boolean | True if an escalation action followed within 180 days. | |
| | `escalated_within_365d` | boolean | True if an escalation action followed within 365 days. | |
| | `escalated_ever` | boolean | True if an escalation action followed at any time after the inspection. | |
| |
| ## 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/vvafiy). |
| |
