"For Cause" Inspections
"For Cause" inspections are performed when other information, such as product quality complaints, adverse events or data from an application or other source, indicate a potential problem with a firm's products that warrants a more timely investigation. In these cases, OC drafts an Inspection Assignment that communicates to the field investigator specific issues that should be addressed in performing the inspection based on the initiating information. Then, similarly to the surveillance inspection, investigators perform the inspection, submit their reports to the district compliance branch who review the findings and make a recommendation for regulatory action when warranted. These recommendations are reviewed by OC, and a final decision is made on the appropriate regulatory action to take.
