Regulatory Intelligence Platform
FDA Tracker
AI-powered surveillance that continuously scans FDA enforcement actions, regulatory updates, and compliance signals — so your quality team knows what's happening before it becomes a problem.
Warning letters, 483 observations, import alerts, product recalls, and draft guidances — parsed, summarised, and delivered with AI-generated insights tailored to your products, sites, and regulatory exposure. No more manually combing through FDA databases. FDA Tracker turns raw regulatory data into actionable intelligence your team can use today.
Auto-scanning 483 ObservationsWarning Letters
in real time.
Free Access
Start using FDA Tracker today — no cost, no commitment.
Access real-time FDA enforcement intelligence, AI-generated summaries, and personalised alerts. Enter your work email and you're in.
AI-Powered Summaries
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 — enabling instant filtering and search.
Personalised 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 — 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 — intelligence reaches the right people instantly.
Supplier & Competitor Watch
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
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 — 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
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's coming, your team can prepare targeted responses for the areas that investigator is most likely to scrutinise.
Historical Intelligence
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 — 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.
Regulatory risk doesn't wait for your next quarterly review. FDA Tracker brings every warning letter, 483 observation, import alert, and guidance update directly to your quality team — parsed, summarised, and contextualised by AI — so you can act on signals the day they appear, not weeks after.
