Analyze FDA Compliance Gaps, Stay Audit Ready with AI
Analyze FDA 483 observations, monitor warning letter trends, and proactively prepare for audits—all in one powerful compliance intelligence platform.

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FDA Tracker – AI-Powered Compliance Intelligence
Analyze FDA 483 observations, monitor warning letter trends, and proactively prepare for audits—all in one powerful compliance intelligence platform.

Analyze FDA Trends
Dive into detailed analyses of FDA observations across six key subsystems: Facilities, Laboratory, Materials, Packaging, Production, and IT/Data Management.

Anticipate Compliance Risks
Track industry-wide FDA enforcement patterns, common violations, and emerging risks based on real-time data from 483s and warning letters.
Audit Readiness Planning
Ensure every site is fully prepared for inspections with targeted compliance interventions.
Analyze FDA Compliance Trends
Track industry-wide FDA enforcement patterns, common violations, and emerging compliance risks based on real-time data from 483s and warning letters.


Understand compliance risks for companies similar to you
Analyze FDA findings across companies similar to yours, identifying top compliance risks in your sector.
Identify Your High-Risk Subsystems
Detect trends in your own compliance performance by mapping against FDA’s most-cited subsystems (Facilities, Lab Controls, Production, etc.).


Analyze FDA Investigator Profiles
Access detailed investigator insights, including their most-cited violations and enforcement history.
Generate Audit Readiness Checklists customized to your FEI
Use FDA enforcement trends and historical insights to generate customized audit checklists for your organization.

Frequently Asked Questions
What is FDA Form 483?
What is the difference between FDA Form 483 and a Warning Letter?
Where can I find FDA 483 reports?

Streamlined Regulatory Updates and Approvals
Utilize AI to automate and assist in the creation of change controls, making complex processes straightforward and error-free.
Monitor FDA Six Systems, Analyse 483s & Investigators
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FDA ESSENTIALS
Learn more about FDA 483s with our comprehensive list of resources
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