The Atlas Platform
Every FDA inspection
since 2010.
If we don't have it,
nobody does.
The complete FDA inspection and enforcement intelligence platform. Searchable in under a second.
Complete and Current
The complete FDA record,
in one search.
FDA Inspections
Every inspection since 2010
Form 483s & EIRs
Structured and indexed
Warning Letters
Complete FDA archive since 2008
Searchable Observations
Indexed by investigator, CFR, keyword
Investigator Reports
Focus areas, citation patterns, trends
International Agencies
MHRA, PMDA, Health Canada, CDSCO, Swissmedic
Plus import alerts, recalls, debarment letters, and complete response letters. All continuously updated.
Data Freshness
The FDA website publishes what's already happened.
Atlas surfaces it as it's happening.
New inspection data arrives through proprietary market intelligence, typically within a business week of an inspection occurring.
The Tools
Search it. Ask it.
Monitor it. Analyze it.
Search and Discovery
AI-enabled search across the entire database. By investigator, company, CFR code, site, keyword, or any combination. Results in under 1 second.
AI Copilot
Ask any question about any investigator, observation, or CFR code. In any language. Get structured, color-coded answers your team can act on in minutes.
Custom Analytics & Alerts
Dashboards built for your exact use case, at no extra cost. Supplier tracking, peer benchmarking, trend analytics. Email and WhatsApp alerts.
Investigator Reports
6,000+ FDA investigator reports. Focus areas by CFR code, citation patterns, and how their approach has changed over time.
How Quality and Regulatory Teams Use Atlas
From inspection preparation to continuous quality improvement.
Inspection Preparation
An investigator is assigned to your site. Search their name. Full history, focus areas, citation patterns. Your team prepares with specific intelligence, not general guidelines.
Supply Chain Monitoring
Upload your supplier and external manufacturer list. Get alerted when any of them face FDA action. See the truth independently, before your supplier tells you their version.
Gap Assessment
Search any observation keyword across the full database. See what the FDA is finding across the industry. Compare against your own processes. Find the gaps your manual reviews miss.
Competitive Benchmarking
Every inspection, 483, and warning letter for any company. Custom peer groups. Trend analytics. See how your quality program compares.
Training and SOP Development
Use real FDA observations and citation patterns to build training programs grounded in what investigators actually focus on, not what a consultant remembered from 5 years ago.
Vendor Audits
Pull the complete inspection history for any supplier or external manufacturer before your audit. Know what the FDA found before you walk in the door.
Why Atlas
How Atlas compares.
| Atlas | Legacy Alternative | FDA Website | Manual Process | |
|---|---|---|---|---|
| Data completeness | 700,000+ inspections, 30,000+ 483s, 11,800+ warning letters, 5 international agencies | Comparable database size | Curated subset only | Limited to one person's effort |
| Data freshness | Typically within a business week | Slower updates | Months behind | Depends who's tracking |
| Search | AI-enabled, under 1 second | Keyword-based | Not searchable | Ctrl+F in PDFs |
| Analytics | Custom, built for your use case | Predetermined, rigid | None | Spreadsheets |
| AI capabilities | Copilot in any language | Recently announced | None | None |
| Support | Direct engineering support | Enterprise support tiers | N/A | N/A |
| Activation | Click to start | Implementation project | Free | Free but manual |
