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We'll pull their full history live.
The most comprehensive FDA inspection dataset, structured and searchable for your specific situation.
Sub-second search · AI copilot · Custom analytics
Trusted by quality and regulatory teams at leading pharma and medical device companies
The Data Gap
30,000+ FDA 483s exist but are out of reach.
The FDA’s full record of inspections, citations, and enforcement actions sits across partial databases, manual spreadsheets, and legacy tools. Quality and regulatory teams rarely see all of it.
Limited database
The FDA website publishes a limited list of 483s and warning letters. Not searchable by investigator, CFR code, site type, peer name, or supplier name.
Manual tracking
Most quality and regulatory teams rely on human knowledge. It is neither current, comprehensive, nor consolidated.
Legacy automation
The only automated product on the market costs around $50k per license. Its data is not the most current, and its analytics are limited.
What Atlas Gives You
Atlas brings search engine intuitiveness to FDA data.
100,000+
Observations
30,000+
Form 483s & EIRs
11,800+
Warning letters
6,000+
Investigator reports
Every investigator, CFR code, company, and site, searchable in one click.
100,000+ searchable observations indexed by investigator, CFR code, company, site, and keyword from the FDA, MHRA, Health Canada, PMDA, and CDSCO.
"If we don't have the data you're looking for, nobody does."
Pratik S. Upadhyay
Top CFRs: 211.192, 211.68, 211.22
47
Inspections
31
483s Issued
Data sourced from the FDA before it is published.
Through proprietary market intelligence, Atlas captures new inspection activity typically within a business week.
Atlas/supply chain alerts
Warning Letter Issued
Supplier: Cronus Pharma, Shamshabad
2 hours ago
Form 483 Issued
Supplier: Eugia Steriles, Paravada
1 day ago
Inspection Completed — NAI
Supplier: Mylan Labs, Sinnar
3 days ago
Ask the copilot anything about any investigator, observation, or CFR code.
Atlas Copilot gives you actionable answers with color-coded breakdowns to any question. When an investigator is already at the site, use Copilot to get quick answers and prepare your operators.
Atlas/ai copilotBased on 12 inspections (2024-2026):
Primary: Investigation of deviations
CFR 211.192 — 9 of 12 inspections (75%)
Secondary: Laboratory controls
CFR 211.160 — 6 of 12 inspections (50%)
Tertiary: Equipment cleaning
CFR 211.67 — 4 of 12 inspections (33%)
Notable shift
Data integrity (211.68) focus increased 23% from 2022-2023. Recommend reviewing your ALCOA+ documentation.
Boyd inspected your Halol facility in March 2024 (NAI outcome). He cited 211.192 and 211.160. No 483 issued.
Tell us what you need. We build it in days, at no extra cost.
Supplier monitoring dashboards, investigator trend views, peer benchmarking. Feature requests go directly to engineering and ship in days, not quarters.
Atlas/analytics/supplier riskSupplier Risk Dashboard
12
Suppliers
3
At Risk
94%
Pass Rate
7
Alerts
483s Issued to Suppliers
Other Capabilities
Notifications, alerts, and more.
Get alerts on the latest inspections, build training programs, and draft investigations and CAPA responses, all from the same record.
Notifications and alerts
Get notified the moment new inspections, 483s, or warning letters land for the companies, investigators, and sites you track.
Training programs
Build investigator and CFR-specific training directly from the record, so operators are ready before an inspection begins.
Investigations and CAPA support
Use the copilot to draft full investigations and CAPA responses grounded in comparable FDA observations.
Health Canada and MHRA readiness
The same workflow extends to Health Canada, MHRA, PMDA, and CDSCO, so teams can prepare for non-FDA audits in one place.
How Quality and Regulatory Teams Use Atlas
Atlas frees up the time spent gathering data, so quality and regulatory teams can focus on using it.
Know your investigator before they arrive.
Type their name and see every inspection, every citation, their CFR focus areas, and how patterns have shifted year over year.
See supplier FDA actions before they tell you.
Upload your supplier list. Get alerted by email or WhatsApp when any of them face FDA action.
Find the gaps your manual reviews miss.
Search any observation keyword across the full database. See what the FDA is finding. Compare against your own processes.
How Atlas Works
Three steps to inspection readiness.
Search
Type any investigator name, company, CFR code, or keyword into Atlas. Results in under 1 second.
See the full picture
Complete history, structured and cross-referenced. Ask the AI copilot to explain anything.
Act on it
Monitor suppliers, competitors, or investigators. Get notified when something changes.
Trusted By Quality and Regulatory Teams
The world’s largest pharma and generics companies have replaced legacy automation with Atlas.
Used by quality, compliance, and regulatory teams across pharma, medical devices, biologics, vaccines, food, and cosmetics. The full FDA record, in one search.
“If management considers the legacy platform against Atlas, I’ll quit my job.”
VP Quality
Top-5 Global Pharma Company
The Team Behind It
Built by ex-Google, Facebook, and Microsoft engineers.
Our search and AI experience is what lets us transform the way you search and find FDA data.
1-click to find anything
Search by investigator, CFR code, company, site, or keyword and get results in under a second.
No onboarding timeline
No implementation project. No setup fees. You're searching the database the same day.
1/3 the price of legacy automation
Named-user annual subscriptions deliver more features than the incumbent at roughly one-third the cost.
The Platform
One platform that grows with your quality and regulatory teams.
Start with Atlas. Get access to our new products as we release them.
Atlas
FDA inspection and enforcement intelligence.
Every 483, EIR, and warning letter since 2010, indexed by investigator, CFR code, and site. Search in under a second. Ask the AI copilot anything.
If we don't have the data, nobody does.
Hedwig
Regulatory guidance aggregator.
Tracks policy across FDA, MHRA, Health Canada, PMDA, and CDSCO. Alerts the moment a rule changes.
Included with Atlas.
Scout
Automated gap assessment.
Upload your SOPs. Scout cross-references them against every observation in Atlas and finds the gaps manual reviews miss.
Recently launched.
Talk to us
Get the search experience on FDA data.
30-minute call. You can even test Atlas against legacy automation, if you have it.