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"dataset": "fda-facility-compliance-intelligence",
"title": "FDA Facility Compliance Intelligence",
"version": "1.0.0",
"source": "FDA Data Dashboard API + openFDA (U.S. Government public domain)",
"record_count": 132080,
"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)."
}
]
}
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