Analyze FDA 483s & Stay Audit Ready

FDA Tracker empowers pharmaceutical companies to readily access detailed insights into FDA Form 483 observations and warning letters.

How it works?

Monitor FDA Compliance  Metrics

Track critical compliance metrics, including the total number of Form 483s issued, most problematic subsystems, and conversion rates of observations to warning letters.

Analyze FDA Subsystem Specific Trends

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

Track Observation Escalations

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.

Profile FDA Investigators

Access detailed profiles of FDA investigators, including their most frequently cited subsystems and inspection patterns.

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.

Anticipate
Focus 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.