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Atlas

Atlas provides FDA inspection and enforcement intelligence for quality and regulatory teams at pharma and medical device companies.

For agents: Atlas: searchable FDA inspection intelligence covering investigators, inspected facilities and Form 483 observations for pharma and medical device quality teams

fda inspectionsform 483pharma compliancemedical device regulationinvestigator lookup

Their llms.txt

The beginning of the file, from our validated copy saved 2026-10-24T12:38:14.526Z. Cached copy · Source on atlas-compliance.ai

# Atlas

> Atlas provides FDA inspection and enforcement intelligence for quality and regulatory teams at pharma and medical device companies.

Use this file as a curated map of Atlas: what it covers, the public FDA inspection data pages, the analytics dashboards, the marketing pages, and all published blog posts.

## What Atlas covers
- FDA inspections since 2010, Form 483s and Establishment Inspection Reports (EIRs), FDA warning letters since 2008, and searchable inspectional observations indexed by investigator, CFR citation, and keyword.
- International agencies: MHRA (UK), PMDA (Japan), Health Canada, CDSCO (India), and Swissmedic.
- Also covers import alerts, recalls, debarment letters, and complete response letters.
- Each FDA investigator, inspected facility, and Form 483 has its own public page under /inspection-intelligence.

## Inspection Intelligence (public data)
- [FDA Inspection Database](https://www.atlas-compliance.ai/inspection-intelligence): Search FDA investigators, inspected facilities, and Form 483s, with the links between them mapped.
- [FDA Form 483 Database](https://www.atlas-compliance.ai/inspection-intelligence/form-483s): Form 483 records by company, facility, investigator, product area, and year, with the observations and the regulations cited.
- [FDA Investigator Lookup](https://www.atlas-compliance.ai/inspection-intelligence/investigators): Each FDA investigator's inspection history, the facilities they inspected, the Form 483 observations they issued, and their co-investigators.
- [FDA Facility Lookup](https://www.atlas-compliance.ai/inspection-intelligence/sites): Inspection history, outcomes, and Form 483s for FDA-inspected facilities, searchable by company name or city.

## Analytics dashboards
- [Atlas Analytics](https://www.atlas-compliance.ai/analytics): Interactive dashboards on FDA and international inspection trends.
- [US FDA Inspections Analytics](https://www.atlas-compliance.ai/analytics/us-fda-inspections-analytics): Contains inspection count vs year charts classified by country and action indicated, inspection count vs category chart and pie chart of top 10 CFR citations.
- [INDIA - Human Drugs - Trends](https://www.atlas-compliance.ai/analytics/india-human-drugs-trends): The recent CFR trends of fda inspections in India under category Human Drugs
- [Region Wise Top Issues](https://www.atlas-compliance.ai/analytics/region-wise-top-issues): The issues reported in US FDA inspections for following regions: NA (North America), LA (Latin America), EMEA (Europe, Middle East and Africa), APAC (Asia-Pacific)
- [Most Prevalent CFRs by GXP and Industry](https://www.atlas-compliance.ai/analytics/most-prevalent-cfrs-by-gxp-and-industry): Most prevalent CFRs by GXP and Industry - Year by Year comparison
- [EMA Annual Report](https://www.atlas-compliance.ai/analytics/ema-annual-report): EMA Annual report of the Good Clinical Practice Inspectors Working Group
- [Health Canada Inspections Report](https://www.atlas-co
…

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