Scored FDA inspection risk corpus

Scored FDA inspection risk corpus: 57k inspection records and 44k citation records locally synced from published Form 483s, annual inspection/citation data and warning-letter context, transformed into three deterministic derived signals — BlindSpot (nine signal families identifying CFR areas accelerating at peer facilities, scored on external strength, site-exposure gap and consequence weight), Observation Risk Score (five-level hierarchical cohort shrinkage across district × product × process with HIGH/MODERATE/LOW/INSUFFICIENT reliability labels), and Inspection Pressure Score (Cox proportional-hazards model, 16 features, forecasting IPS-3/6/12 horizons).

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Coverage

Universe, instruments and categories.

Industry: PharmaceuticalsApplication Software
Instruments: equities
Categories: Alternative

Dataset card

Type: not stated
Format: Tabular + text served through a hosted single-facility web app, exporting date-stamped executive brief PDFs; scoring runs entirely on stored evidence snapshots with no live agency calls, so the corpus is effectively a versioned snapshot dataset. No API or bulk export is offered.
Volume: 57,000 inspection records and 44,000 citation records as of the 10 Apr 2026 snapshot, plus derived score and reliability layers. Materially smaller than category peers (one competitor indexes 148,507 Form 483s and 88,971 observations across 232,103 sites), so this is a focused analytical corpus rather than a comprehensive archive.
Users: ~0-1 — the product is explicitly a single-facility beta pilot with one named operator seat, so the current user base is effectively the pilot customer plus the builder; multi-site and multi-user workflows are only planned for a later platform rollout.
History: not stated
Update frequency: not stated
Growth: Early / pre-scale — launched around April 2026 and still in single-facility beta with one operator seat; multi-site, multi-user and enterprise workflows are explicitly deferred to a future rollout. Parent consultancy is a 1-employee firm founded 2023.
Launched: ~April 2026 — the founder's public launch announcement ('483Radar is live') and the site's own single-facility beta framing date the release to Q2 2026; the parent company LeanStorming was founded 2023.
Delivery: not stated
Entity mapping: not stated
Sample: not stated
Point-in-time: not stated
Licence: not stated

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