Handling FDA 483 Warning Letters

Learn how USDM helped a large biotech company address FDA 483 warning letters and build a better process to manage data integrity challenges.

The Situation
  • A commercial biotech company with 12B in revenue
  • Needed to address FDA 483 warning letters, CAPAs
  • Previous analysis was done, but the root cause not successfully determined
  • Required a fast but thorough remediation solution
  • Lack of internal resources with the knowledge and experience to assess and remediate the current observations
The Solution
  • Conducted a high level audit to guide assessors to critical areas for investigation
  • Conducted an assessment of the company’s computer system validation (CSV) processes
  • Conducted an assessment of data integrity processes and practices
  • Developed tools for the customer to evaluate their CSV and data integrity capabilities in the future
  • Developed process maps to identify potential and unforeseen data integrity vulnerabilities in the future
  • Deployed reusable tools using criteria provided by the customer that was easy to understand and followed a transparent data model

Responses to FDA findings trustworthy, rapid, delivery

Remediation solution to address root causes of violations

More robust data integrity program implemented

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