Complaint Investigations: Are They Required When Products Are Used Off-Label?

Q: Does FDA require complaint investigations for a “lack of effect” when there is an off-label use of the product?

Or, can we log the report into our complaint investigations system for tracking purposes, then close the report with a note saying that the product was not used as indicated — and therefore is not a true lack of effect?

A: The short answer is yes — you can log the report and close complaint investigations as you have described.

Answered by Denise Dion, EduQuest VP of Regulatory and Quality Services, 18 years as an FDA investigator and co-developer of FDA’s Quality Systems Inspection Technique (QSIT), and lead instructor of EduQuest’s 12-hour training class entitled, The CAPA Clinic: FDA Rules for Effective CAPA Systems, Failure Investigations, and Complaint Management, 


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