The number of warning letters sent by the U.S. Food and Drug Administration (FDA) jHow_to_avoid_7_FDA_compliance_pitfalls.jpgumped nearly 80 percent from 2007 to 2013, with life science companies contributing the most to this number.
Staying ahead of FDA compliance issues can be a difficult task, especially when you consider all the moving parts involved in the pharmaceutical and medical device manufacturing process.
The top FDA compliance pitfalls are :
1. Not Documenting Procedures
2. Inadequate Complaint Handling Processes
3. Poor Corrective Action Processes
4. Insufficient Supplier Controls
5. Audit Problems
6. Training Procedures
7. Issues with Laboratory Controls, Monitoring and Calibration.
