Analyze FDA 483s & Stay Audit Ready
FDA Tracker empowers pharmaceutical companies to readily access detailed insights into FDA 483 observations and warning letters, supporting audit readiness and compliance.
How it works?
Track essential compliance metrics with insights from our FDA 483 database, including the total number of Form 483s issued, most problematic subsystems, and conversion rates of observations to warning letters.
Explore detailed analyses of FDA observations across six major subsystems: Facilities, Laboratory, Materials, Packaging, Production, and IT/Data Management, using data from our FDA inspection database.
Monitor the escalation of Form 483 observations to warning letters. FDA Tracker allows you to track and analyze these escalations, helping you understand the severity of compliance issues and take corrective action.
Access detailed profiles of FDA investigators, including their most frequently cited subsystems and inspection patterns, assisting in FDA audit checklist preparation.
Targeted Compliance Interventions
FDA Tracker's subsystem analysis helps you identify the most cited sub-systems that are most frequently cited, leading to more effective and targeted compliance interventions.
AnticipateFocus Area
With detailed profiles of FDA investigators, you can anticipate the focus areas of upcoming inspections and tailor your preparation accordingly.
Tailored Audit Preparation
Ensure your team is thoroughly prepared for FDA audits, improving your readiness and reducing the likelihood of negative audit outcomes.
Reduced Escalation of Observations
By tracking how many Form 483 observations escalate into warning letters, FDA Tracker enables your team to prioritize critical issues and take corrective actions promptly.
Frequently Asked Questions
Streamlined Regulatory Updates and Approvals
Utilize AI to automate and assist in the creation of change controls, making complex processes straightforward and error-free.