Industryiceberg

Structured, FEI-mapped FDA GMP inspection observation database covering 2008-2026: each observation record carries the FDA Facility Establishment Identifier, legal entity name, inspection end date, the specific Act/CFR citation breached, the programme-area system classification (Quality, Facilities & Equipment, Laboratory Controls, Production, Packaging & Labelling), the full observation narrative, and a mapped link to the source Form 483 and any related warning letter, with country-level and programme-area trend aggregation on top

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Coverage

Universe, instruments and categories.

Industry: PharmaceuticalsApplication Software
Instruments: equities
Categories: AlternativeReferenceESGSentiment
Regions: USAPACOther
Sample tickers: APTEC.TOLUPIN.NSSUNPHARMA.NSGRANULES.NSBMYVRTX

Dataset card

Type: not stated
Format: Tabular (backend database queried through a web dashboard with trend charts, a country map and a record table carrying document links)
Volume: 18 years of FDA GMP observation history (2008-2026); one programme-area slice alone shows 5,496 observations mapped to 270 Forms 483 and 29 warning letters, so the full multi-programme corpus is plausibly in the low hundreds of thousands of observation records (request the exact total — the dashboard's headline counters render client-side and did not print at crawl time)
Users: Low — est. tens to low hundreds of enterprise seats (inferred from an 11-person IT-services company selling an enterprise GMP intelligence platform through a demo-request funnel)
History: 18 years
Update frequency: not stated
Growth: Active (dashboard carries observations with inspection end dates in January and February 2026 and links to warning letters issued late 2025, so the ingest pipeline is current; demo-request funnel live)
Launched: Est. 2023-2025 for the CompliSense product (an 11-person IT-services company with no funding record applying AI to public FDA data in the current regulatory-AI wave); the data it indexes reaches back to 2008
Delivery: not stated
Entity mapping: not stated
Sample: not stated
Point-in-time: not stated
Licence: not stated

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