Q: Does FDA have the legal right to request an internal audit report or an annual product review report? I’ve heard that in most cases FDA won’t request those kind of reports, but instead may ask to review our Standard Operating Procedures (SOPs) related to internal auditing. What’s been your experience?
A: Yes, FDA has the legal right to request an internal audit report. But it rarely does.
According to its own compliance policy for pharmaceutical companies, FDA chooses to not routinely look at an internal audit report or your product review reports. But in special circumstances, the Agency may ask to review them if it deems them appropriate to its investigation.
Otherwise, in most routine inspections, FDA will look to see if the reviews have occurred. So you should be prepared to provide some kind of documentation, such as a review schedule or the cover page of your latest audit report.
For medical device companies, FDA field investigators are not allowed to ask for internal audit reports.
For medical device companies, FDA field investigators are not allowed to ask for internal audit reports. If the Agency wants to see them, it must submit the request in writing from a senior FDA official, usually the District Director or, for non-U.S. firms, the CDRH Compliance Branch management.
Again, in most cases, you’ll more likely be asked to provide some documentation such as an audit schedule or report cover.
Answered by Denise Dion, EduQuest VP of Regulatory and Quality Services (18 years as an FDA investigator and co-editor of FDA’s Investigations Operations Manual) and instructor of EduQuest’s 12-hour training class entitled, The CAPA Clinic: FDA Rules for Effective CAPA Systems, Failure Investigations and Complaint Management.