Pre Approval Inspection - The Exit Meeting

The exit meeting should be attended by the inspection coordinator, plant/site manager and other key management personnel including QA/QC managers. Tact, responsiveness and thorough note-taking are essential.

During the exit meeting, the inspector verbally concludes the inspection and may leave a 483 (483 is the number assigned to the form that includes the citations found by FDA inspectors) if potential violations have been observed. Any misunderstandings or misinterpretations relating to the presented facts should be cleared up at this point. It is important to remember that only facts can be discussed and it is too late to support misunderstandings with further documentation or data during the meeting.

If you dispute any of the findings that are presented, you can communicate your concerns to the FDA district office. However, it is important to remember that a good inspection coordinator should have been able to resolve such issues during the inspection, thereby avoiding confrontation during the exit meeting. If measures have already been taken or put in place to rectify any observations, these should be brought to the attention of the inspector by asking for the observations to be annotated. There are four common terms used to annotate a 483: “Reported corrected, not verified”; “Corrected and verified”; “Promised to correct” and “Under consideration”. However, the FDA inspector is under no obligation to add these comments to the 483 form observations. The site is also permitted to ask if the inspector will recommend the approval of the inspected product or site (Cover letter by the district office to the establishment inspection report – EIR).

The company should speak with a single voice, usually through the inspection coordinator or the most senior executive present at the exit meeting. At the end of the meeting, this person should also make some concluding remarks (stating, for example, that the inspection was fair, that all verbal and written findings will be taken seriously, that the inspection has been of great value to the site, that the site will maintain this high GMP level, that inspection motivates personnel) and thank the inspector for his or her time and effort.