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Preparing for Your FDA Inspection
If you sell medical devices in the USA, the FDA is coming. Whether you are located in the United States or in Europe or elsewhere abroad – you must be prepared. Making some last minute preparations could mean the difference between a good audit and one with a multitude of 483s.
It’s Like Running A Marathon
You wouldn’t expect a marathon runner to go into a race without having prepared along the way. In fact an FDA inspection is very similar to running a marathon – in as much as the analogy for preparing. There are two very important similarities that make running a successful marathon and having a successful FDA audit become a reality.
1) Don’t wait for the last minute to prepare. Like a successful marathon, you must condition your organization into compliance.
2) And second, just like the way a marathoner prepares for the big race, you will need to take specific steps in preparing for the actual audit.
This article
will concentrate mainly on the second element of preparing for
the big one. However, this may be useful for establishing a gap
analysis. It is highly recommended that you go through mock
inspections on a routine basis.
FDA Inspections
Never gauge the expectation of an FDA audit by previous audits.
Auditors are like fingerprints; you never find any two the
same. Interpretation of findings is for the most part
determined by the experience and knowledge of the inspector. In
most if not all cases the auditor will have had at least the
basic training and should be able to smoke out the worst of your
organizations closet skeletons. When preparing for an audit
always assume that you will have a seasoned highly knowledgeable
auditor. It's better to over-prepare than to underestimate the
extent of the inspection.