RubyIntelligence/fda-high-risk-facilities-watchlist

FDA High-Risk Facilities Watchlist

Version: 1.0.0 | Records: 4,574 | Price: $1,500 | Source: FDA (public domain)

Dataset Summary

Every facility on this watchlist carries a composite risk score of ≥ 50, and 84.8% have already escalated to a Warning Letter or stronger enforcement action — both figures reproduce directly from the shipped file. This is the regulatory tail: the facilities with the most serious and most recent FDA exposure.

A focused watchlist of the 4,574 highest-risk FDA-regulated facilities (risk score ≥ 50) — the facilities with the most serious and most recent regulatory exposure. The same fields as the full Facility Compliance Intelligence product, pre-filtered to the tail that matters. A fast, low-cost entry point for supplier risk screening and audit prioritization.

Current through 2026 — the watchlist includes facilities from the most recent regulatory cycles (173 facilities with their most recent inspection in 2026, 754 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 high-risk facility screening 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-heavy by construction (reproducible from this file). Because the watchlist is pre-filtered to risk score ≥ 50, averaging ever_escalated_to_wl over the shipped rows gives 84.8% — these facilities have overwhelmingly already escalated to a Warning Letter or stronger action, versus ~5% across the full population of FDA-inspected facilities. The underlying severity-graded escalation contrast (OAI inspections escalating far more often than NAI — a ~26× relationship) is validated on the full FDA Facility Compliance Intelligence product; on this pre-filtered tail escalation rates are uniformly high by design, so the contrast is intentionally compressed here.
• 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 ~15% of facilities on this watchlist — the high-risk tail is escalation-heavy, so most rows here do carry an escalation time (across the full facility population it is ~95%).
• Null-by-design citation field. The most_cited_cfr field is null for facilities with no posted citations on record (~17% of facilities on this watchlist; ~64% across the full facility population). 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 (~17% of facilities on this watchlist).
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 ~15% of facilities on this watchlist.
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_count15 + warning_letter_count20 + recall_count10 + min(import_refusal_count2,20) + 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.