Expert: FDA Scrutinizes Complaint-Handling Systems

http://www.fdanews.com/newsletter/article?issueId=10464&articleId=96042
The FDA is increasingly scrutinizing manufacturers’ product complaint systems and procedures, according to David Dills, senior consultant with Parexel Consulting. The FDA has been closely examining records during inspections and evaluating whether firms find root causes of complaints and appropriately close investigation files, Dills said at the recent Center for Business Intelligence 5th Annual Product Complaints for Bio/Pharmaceuticals and Medical Devices conference.
Over the past year, the number of Form 483 observations for product complaints has been at an all-time high, Dills said, as agency field investigators are spending more time examining company complaint sections during inspections. The audits are focusing on documentation and reasons for closure of investigation files. In noting that excessive product complaints are sometimes a sign of product design flaws, Dills said that complaint files, and the reasons behind closing complaint investigations, need to stand up in court. He also said that it is important for firms to not prematurely jump to conclusions regarding the outcomes of investigations. They should wait until investigations are completed.