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+# FDA Inspection & Escalation Dataset
+**Version:** 1.0.0 | **Records:** 271,609 | **Price:** $2,500 | **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.**
+
+Every FDA inspection on record — 271,609 inspections — enriched with citation detail, outcome classification, and the premium escalation fields that link each inspection to the Warning Letter (or stronger action) that followed it, with exact timing. Built for RA/QA teams benchmarking inspection outcomes, consultants modelling enforcement risk, and analysts studying what inspection findings actually lead to enforcement.
+
+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 inspection-level 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 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.
+- **Null-by-design escalation timing.** The `days_inspection_to_warning_letter` and
+  `escalated_warning_letter_action_type` fields are null by design for inspections not followed by a
+  Warning Letter or stronger action (`escalated_ever` = false) — the large majority of inspections,
+  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`) are empty/null for inspections with no posted citations on record. This
+  is accurate — many inspections, particularly those classified NAI, result in no citations. 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). Null by design when no escalation followed (the large majority of inspections). 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); null by design when no escalation followed. |
+| `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/dddwos).