Linked FDA enforcement knowledge graph: 109,238 documents

Name: Linked FDA enforcement knowledge graph: 109,238 documents (108,419 Form 483 observations, 819 Warning Letters, 17,711 recalls) resolved across 16,555 company profiles, with every document rule-classified by GMP category and facility type, and confidence-scored causal links showing how a 483 escalates into a Warning Letter and then a recall.
Creator: 483signal

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Linked FDA enforcement knowledge graph: 109,238 documents (108,419 Form 483 observations, 819 Warning Letters, 17,711 recalls) resolved across 16,555 company profiles, with every document rule-classified by GMP category and facility type, and confidence-scored causal links showing how a 483 escalates into a Warning Letter and then a recall.

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Coverage

Universe, instruments and categories.

Industry: PharmaceuticalsApplication Software
Instruments: equities
Categories: AlternativeSupply ChainReferenceSentiment
Regions: USUKAPACEurope
Sample tickers: AMRXFreseniusTEVAVTRSCAHBDXISRGDABUR.BOMRPLNTH

Dataset card

Type: not stated
Format: Tabular + text — structured records with CSV export, plus extracted full text of each 483/Warning Letter/recall, and a JSON API (200-1,000 requests/day by tier).
Volume: 109,238 documents total (108,419 Form 483s, 819 Warning Letters, 17,711 recalls) across 16,555 company profiles, refreshed daily with 1-3 business day publication lag.
Users: No disclosed user count for the self-serve subscription; freemium tiers plus a 5-seat Enterprise plan imply an installed base in the low thousands of registered users at most.
History: 17 years
Update frequency: not stated
Growth: Active — daily FDA ingestion, recalls refreshed weekly, enforcement entries current through mid-2026, and tiered paid plans (Free/Professional/Enterprise) being rolled out with API access and PDF reports still 'coming soon' (i.e. product is shipping).
Launched: ~2024-2025 — contemporary single-page SaaS built on Ghost, with paid tiers and an API recently added and features still marked 'coming soon'; no earlier archive or press footprint found.
Delivery: not stated
Entity mapping: not stated
Sample: not stated
Point-in-time: not stated
Licence: not stated

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