Preparing your company for an FDA inspection is no easy task, but if you do all the adequate preparation necessary and know all the key points your company will be inspected on, your company has a much better chance of success.  Like it or not, if your business is involved in any way with the FDA, sooner or later, your company will face inspection.  If your company is not adequately prepared your company or its products can be seized, penalized, or even brought up on charges. Instead of running from this, or trying everything you can to avoid it, there are simple steps your company can take to be as ready as you can when a surprise FDA inspection comes your way.  Here is how.

One of the most important steps you can take when preparing for an FDA inspection is to give your company enough time to prepare itself.  If your inspection is happening in a few weeks, then it will be almost impossible to prepare your company properly for the lengthy inspection.  Planning for an FDA inspection must take place over the long term, and a few weeks of half-hearted planning will just not suffice.  In order to prepare your company adequately, you will need at least 6 months give or take, of research and planning to be able to be thoroughly prepared for the audit.

One of the preparatory steps you can take for an FDA audit is hiring a pharmaceutical consultancy firm that will run mock audits until your company is adequately prepared.  They will thoroughly test your facilities in such a way that you will better understand your strong points, as well as your areas of concern.  They can update you about any new rules or regulations that you may encounter in your FDA audit, as well as give your organization advice on the best way to operate your facilities.

Another thing you will want to do when preparing for your FDA inspection is to take some time and familiarize yourself with the FDA procedural list.  Knowing what kind of questions your FDA inspector will ask in advance and can be a great advantage to your company when preparing for the inspection.  Also, doing some preparation on the FDA inspection procedures will enable you to feel more confident when the inspection comes around, as well as give you an element of control over the situation.  Whatever type of questions may be asked, you’ll be ready for them.

Another smart thing to do is to have a trusted note taker alongside of you during the entire length of the inspection.  This is important if there should be any disputes arising during the inspection, or in case you would like to dispute something down the line.  Your notetaker should also be one of the more knowledgeable employees in your company, one who could possibly assist you if questions arise.  If you prepare your company thoroughly, and if you know the inspectors’ procedures inside and out, then you have little to fear in your upcoming FDA inspection, and you should pass everything with no problems.

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