So, you have come to the end of your inspectional process and now you are sitting in your conference room with the FDA inspectors waiting for them to tell you how you have done. This is a stressful time, but if you done your homework and prepared well for the inspection, there should be no reason why you should fear the outcome.
Remember, the inspection is a snapshot of your compliance program and not an absolute measure of everything associated with that program, that would be impossible in the time to do that thoroughly. So, with this in mind, your good preparation should enable you to address the majority of the questions that should arise.
It is important to keep calm during this exit interview and not to be defensive about the questions that will arise from the assessment. It is perfectly acceptable to ask questions, especially where clarification of the points is needed to enable you to fully comprehend their point of view/opinion. In relation to this, it is not unreasonable to push back if you don’t agree with the comments being made, but if you are going to do that, then it is advisable to make sure that you have all the necessary data to back up your claim and the rationale for why you disagree with their point of view. Failure to do that will result in an unwelcome response from the inspection team.
It’s important to remember that any points noted on the 483 inspectional form only represents a summary of the total assessment , so it’s vital that one understands both of the immediate and overarching implications intended by any observations noted on the form. In essence, the 483 only represents a summary and a more complete picture will be provided in the establishment inspection report which will come in the coming weeks.
Use these close out meetings to learn something from the inspection team that you can incorporate into your inspection response. Only commit to those tasks and actions that you have some control over and for which you can be sure to have completed within the proposed timeline.
Remember, you only have 15 days to respond to a 483, so it is imperative that that is completed with objective proof to neutralize any concerns raised by the inspection team. In addressing these concerns, FDA will expect a menu of remediation activities that will involve measures to produce interim controls as well as those with more far-reaching implications.
It’s important in preparing your response to assure that it is both reasonable and provided with a professional tone, especially given that the person who will probably read this will most likely be someone who has not seen your firm or its processes and so the impression they have will be solely dependent upon the observations and the quality of your responses.
One factor that will assist you to ensure success will be to keep your inspectional readiness team current in his responsibilities and to mobilize them to respond to the inspectional observations once the FDA inspectors leave the site.
Upon leaving the site, the company readiness team should dissect the 483 observations and methodically plan appropriate teams to address each of the remediation activities. This is best organized using a matrix that will itemize tasks, resources, and timelines, supplemented with frequent /daily meetings to properly integrate the necessary factors that will ensure a comprehensive coherent response.
Frequently a consultant can add value with this process by bringing a fresh pair of eyes to the table, something that may provide a broader level of perspective. This is something that is well worth considering rather than suffering the damaging consequences that could arise from a misunderstanding.
