Stay audit ready by analyzing FDA compliance gaps with AI and FDA Form 483 database
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
Dive into detailed analyses of FDA observations across six key subsystems: Facilities, Laboratory, Materials, Packaging, Production, and IT/Data Management.
Track industry-wide FDA enforcement patterns, common violations, and emerging risks based on real-time data from 483s and warning letters.
Ensure every site is fully prepared for inspections with targeted compliance interventions.
Frequently Asked Questions
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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
Learn more about FDA 483s with our comprehensive list of resources
Top FDA observations Cleaning Validation in Pharma Industry
Build understanding on the recent FDA observations in cleaning validation.
Top FDA 483 Observations in Batch Manufacturing
Top Batch Manufacturing FDA 483 Insights
FDA Observations Audit Management
Streamline FDA Audit Management with expert insights for regulatory compliance
FDA Observations CAPA
Streamline FDA CAPA management with expert insights for regulatory compliance
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