FDA Tracker
Know what the FDA is doing,
before your next inspection.
FDA Tracker scans every enforcement action as it is published and turns it into intelligence tailored to your products, sites, and suppliers.
Free forever. No credit card. 148,000+ FDA records since 2012.
The problem
Regulatory risk shows up too late.
The signals that predict your next 483 are public the day they are published. Most teams just have no way to see them in time.
The signals are buried
The FDA publishes warning letters, 483s, import alerts, and recalls across separate databases, as unstructured documents that no one cross-references.
Manual monitoring does not scale
Combing FDA.gov by hand is slow and incomplete, so the actions that matter to your products and suppliers slip past unnoticed.
You find out at the inspection
The pattern an inspector cites was visible across the industry for months. Without systematic intelligence, you learn it the expensive way.
Capabilities
Every FDA signal, parsed and put to work.
FDA Tracker turns the full stream of FDA enforcement activity into one searchable, enriched, and alert-driven workspace, from AI summaries and personalised alerts to investigator profiling and historical search.
One workspace for everything the FDA does.
Warning letters, Form 483 observations, import alerts, recalls, and guidances, all ingested as they are published, then summarised, scored, and cross-referenced so your quality and regulatory teams can act on signals the day they appear. Explore the live data behind it in our FDA warning letter archive.
FDA Tracker Regulatory Intelligence Modules
AI-Powered Summaries:AI Summaries of FDA Enforcement Actions
Every FDA action is automatically parsed and enriched: entities extracted, categories tagged, content summarised, and context annotated, so your team gets the insight, not the noise.
Entity Extraction.
Companies, products, manufacturing sites, and regulatory citations are automatically identified and linked across documents.
Plain-Language Summaries.
Complex FDA documents distilled into clear, actionable summaries your quality team can scan in seconds.
Intelligent Tagging.
Every action auto-tagged by therapeutic area, dosage form, violation type, and severity, so filtering and search are instant.
Personalised Alerts:Personalised FDA Regulatory Alerts
FDA Tracker learns what matters to your organisation and delivers alerts tailored to your products, manufacturing sites, and regulatory exposure.
Configurable Alert Profiles.
Set up alerts by product, site, therapeutic area, or violation type, and only see what is relevant to your operations.
Relevance Scoring.
Every FDA action is scored for relevance to your organisation so you can prioritise what needs attention right now.
Multi-Channel Delivery.
Email digests, in-app notifications, and team-level alert routing get intelligence to the right people instantly.
Supplier & Competitor Watch:FDA Supplier and Competitor Monitoring
Track FDA enforcement actions against suppliers in your approved vendor list and competitors in your market, so you can respond to supply chain risks early.
Approved Supplier Monitoring.
Upload your vendor list and get alerted the moment a supplier receives an FDA warning letter, 483 observation, or import alert.
Competitor Benchmarking.
See how enforcement trends affect competitors in your therapeutic area, and where you may face similar scrutiny.
Supply Chain Risk Signals.
Early warning for API and excipient supply disruptions before they impact your production schedule.
Trend Analytics:FDA 483 and Warning Letter Trend Analytics
Identify enforcement patterns before they become industry-wide issues. FDA Tracker surfaces emerging trends across violation types, therapeutic areas, and geographies.
483 Observation Trends.
Track citation frequency by category over time, and see data integrity, cleaning validation, or process control trends as they develop.
Warning Letter Pattern Analysis.
Identify which dosage forms, facility types, and violation categories are drawing increased FDA attention.
Geographic & Category Heatmaps.
Import alert frequency by country, product type, and reason, visualised so emerging risk areas are obvious.
Investigator Profiling:FDA Investigator Profiles and Citation Patterns
Build intelligence profiles on FDA investigators before they arrive at your site: their inspection history, citation patterns, focus areas, and enforcement track record.
Inspection History.
See every inspection an investigator has conducted: which sites, what was cited, and how often observations led to warning letters.
Citation Pattern Analysis.
Understand an investigator’s focus areas, whether they tend to cite data integrity, cleaning validation, process controls, or laboratory practices.
Pre-Inspection Preparation.
When you know who is coming, your team can prepare targeted responses for the areas that investigator is most likely to scrutinise.
Historical Intelligence:Searchable FDA Enforcement History Since 2012
Access a searchable archive of over 148,000 FDA enforcement records going back to 2012, fully indexed, enriched, and cross-referenced.
Full-Text Search.
Search across all FDA action types by keyword, company, product, violation type, or date range, with results in milliseconds.
Cross-Referenced Entities.
See every FDA action linked to a specific company, site, or product, building a complete enforcement profile over time.
Pre-Inspection Research.
Before an FDA inspection, pull the complete enforcement history for your sites, products, and peer companies in minutes.
Use cases
How quality and regulatory teams use FDA Tracker.
Pre-Inspection Risk Intelligence
Read the use case
First FDA Inspection Readiness for CDMOs
Read the use case
Audit Readiness by FDA Six Systems
Read the use caseIntelligence
From raw FDA data to intelligence you can act on.
FDA Tracker does not just collect enforcement actions. It reads them, connects them, and tells you which ones matter to you, the day they appear.
Parsed and enriched, automatically.
Every action is read by AI: entities extracted, categories tagged, a plain-language summary written, and the source linked. You get the insight, not 40 pages of PDF.
Scored to your exposure.
Each action is ranked against your products, sites, suppliers, and jurisdiction, so your team sees what is relevant to you first, not a generic firehose.
The whole picture, cross-referenced.
148,000+ records since 2012, linked by company, site, product, and investigator, so one search rebuilds a complete enforcement history in seconds.
Auto-scanning warning letters, 483s, import alerts, recalls, and guidances around the clock, with new actions parsed within minutes of publication.
Proven at Scale
Running in production at 400+ GMP facilities
New Jersey, USA
Automated HBEL-based cleaning validation with risk-based protocol generation, ensuring continuous FDA and EMA compliance.
Get started free
Start tracking the FDA in under a minute.
No procurement, no demo, no credit card. Enter a work email and you are in, with full access from the first login.
Enter your work email
Sign up free in seconds. No credit card, no trial clock, and full access from the first login.
Set your watchlist
Add the products, manufacturing sites, suppliers, and competitors you care about, and choose how you want to be alerted.
Get the signal first
AI-summarised alerts reach your inbox the day a relevant action is published, scored by how much it matters to you.
Free forever. No credit card. 148,000+ FDA records since 2012.
FAQ
Frequently asked questions
Is FDA Tracker really free?
Yes. FDA Tracker is free to use with a work email, with no credit card and no trial clock. You get AI-generated summaries, personalised alerts, and full search across the enforcement archive from the moment you sign up.
What FDA data does FDA Tracker cover?
FDA Tracker monitors the full range of FDA enforcement and regulatory activity: warning letters, Form 483 observations, import alerts, recalls, and draft and final guidances. The searchable archive holds more than 148,000 records going back to 2012, and new actions are ingested continuously as the FDA publishes them.
How quickly do alerts arrive after the FDA publishes an action?
FDA Tracker scans FDA sources around the clock. When a new action is published, it is parsed, summarised, scored for relevance, and pushed to the people who follow that product, site, or supplier, usually within minutes of publication.
How are the AI summaries generated, and can I trust them?
Each FDA document is parsed by AI that extracts the entities (companies, sites, products, citations), tags the categories, and distils a plain-language summary. Every summary links back to the original FDA document, so your team can verify the source in one click rather than taking the summary on faith.
Can I monitor my own suppliers and competitors?
Yes. Upload your approved vendor list or build a watchlist of competitors, and FDA Tracker alerts you the moment any of them receives a warning letter, 483 observation, import alert, or recall. It is an early-warning system for supply-chain and competitive risk, not just your own facilities.
Is my watchlist and company data private?
Yes. FDA Tracker reads public FDA data, but your watchlists, alert profiles, and searches are private to your account and are not shared with other organisations. Your configuration stays yours.
How is this different from searching the FDA’s own databases?
FDA enforcement data is spread across separate systems, published as unstructured documents, and never cross-referenced. FDA Tracker ingests all of it, links the entities across documents, scores each action for relevance to your products and sites, and alerts you proactively, so you stop manually combing databases and start acting on signals the day they appear.
How does FDA Tracker relate to Leucine’s other products?
FDA Tracker is built by Leucine, the team behind the AI-native MES, CLEEN cleaning validation, and LeucineOS platforms used across 400+ GMP facilities. FDA Tracker is the free, self-serve regulatory-intelligence product; the same enforcement intelligence underpins pre-inspection readiness for teams running the wider Leucine platform.
The platform
FDA Tracker is your free front door to LeucineOS.
FDA Tracker tells you what the FDA is doing. LeucineOS is the AI-native platform that acts on it: manufacturing execution, cleaning validation, document control, and quality operations on one 21 CFR Part 11 system, live across 400+ GMP facilities.
Explore LeucineOS
Get started
See the FDA before your next inspection.
Free regulatory intelligence for your quality and regulatory teams. Enter a work email and start tracking warning letters, 483s, and inspection trends today.