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
The Results
- Responses to FDA findings trustworthy, rapid, delivery
- Remediation solution to address root causes of violations
- More robust data integrity program implemented