Customer Complaint Investigation

Customer Complaint Investigation is the documented process to analyze the root cause of a reported product issue, assess risk, and determine required corrective actions. 
 
For drugs, 21 CFR 211.198 requires each complaint involving possible quality defects to be reviewed and investigated by the quality unit, with written records, evidence and conclusions.  
 
For medical devices, 21 CFR 820.198 requires evaluation, investigation or justified non-investigation, and linkage to CAPA when needed.