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schema.json

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+{
+  "dataset": "fda-high-risk-facilities-watchlist",
+  "title": "FDA High-Risk Facilities Watchlist",
+  "version": "1.0.0",
+  "source": "FDA Data Dashboard API + openFDA (U.S. Government public domain)",
+  "record_count": 4574,
+  "field_count": 25,
+  "fields": [
+    {
+      "name": "fei_number",
+      "type": "string",
+      "description": "FDA Facility Establishment Identifier (FEI) \u2014 the cross-source join key."
+    },
+    {
+      "name": "legal_name",
+      "type": "string",
+      "description": "Facility legal name, taken from its most recent inspection record."
+    },
+    {
+      "name": "city",
+      "type": "string",
+      "description": "Facility city (most recent inspection record)."
+    },
+    {
+      "name": "state",
+      "type": "string",
+      "description": "Facility state/province (most recent inspection record)."
+    },
+    {
+      "name": "country",
+      "type": "string",
+      "description": "Facility country (most recent inspection record)."
+    },
+    {
+      "name": "product_types",
+      "type": "list<string>",
+      "description": "Distinct FDA product areas inspected at this facility (e.g. Drugs, Devices, Foods)."
+    },
+    {
+      "name": "total_inspections",
+      "type": "integer",
+      "description": "Count of distinct FDA inspections on record for this facility."
+    },
+    {
+      "name": "oai_count",
+      "type": "integer",
+      "description": "Inspections classified Official Action Indicated (OAI) \u2014 the most serious outcome."
+    },
+    {
+      "name": "vai_count",
+      "type": "integer",
+      "description": "Inspections classified Voluntary Action Indicated (VAI)."
+    },
+    {
+      "name": "nai_count",
+      "type": "integer",
+      "description": "Inspections classified No Action Indicated (NAI)."
+    },
+    {
+      "name": "most_recent_inspection_date",
+      "type": "date",
+      "description": "End date of the facility's most recent inspection."
+    },
+    {
+      "name": "most_recent_classification",
+      "type": "string",
+      "description": "Classification of the most recent inspection (full text)."
+    },
+    {
+      "name": "most_recent_classification_code",
+      "type": "string",
+      "description": "Classification code of the most recent inspection (NAI/VAI/OAI)."
+    },
+    {
+      "name": "warning_letter_count",
+      "type": "integer",
+      "description": "Count of Warning Letter compliance actions issued to this FEI."
+    },
+    {
+      "name": "recall_count",
+      "type": "integer",
+      "description": "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)."
+    },
+    {
+      "name": "import_refusal_count",
+      "type": "integer",
+      "description": "Count of FDA import refusals recorded against this FEI."
+    },
+    {
+      "name": "total_citations",
+      "type": "integer",
+      "description": "Total inspection citations (483 observations) recorded across all inspections."
+    },
+    {
+      "name": "distinct_cfr_codes",
+      "type": "integer",
+      "description": "Number of distinct CFR codes cited across the facility's inspections."
+    },
+    {
+      "name": "repeat_citation_flag",
+      "type": "boolean",
+      "description": "True if the same CFR code was cited across 2+ distinct inspections."
+    },
+    {
+      "name": "most_cited_cfr",
+      "type": "string",
+      "description": "The CFR code cited across the most distinct inspections at this facility."
+    },
+    {
+      "name": "ever_escalated_to_wl",
+      "type": "boolean",
+      "description": "True if any inspection at this facility was followed by a Warning Letter (or stronger)."
+    },
+    {
+      "name": "fastest_escalation_days",
+      "type": "integer",
+      "description": "Shortest observed gap (days) from an inspection end to a subsequent Warning Letter; null if none."
+    },
+    {
+      "name": "has_510k_clearance",
+      "type": "boolean",
+      "description": "True if the facility holds at least one 510(k) device clearance."
+    },
+    {
+      "name": "count_510k",
+      "type": "integer",
+      "description": "Number of 510(k) device clearances linked to this facility's FEI."
+    },
+    {
+      "name": "facility_risk_score",
+      "type": "float",
+      "description": "Composite regulatory-risk score, 0\u2013100 (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)."
+    }
+  ]
+}