People often ask me how best to prepare for a Food and Drug Administration (FDA) inspection when you know that you have problems. My first response is that they have already taken the first step: acknowledging that there are problems. Believe me; that is a huge first step. Just like Alcoholics Anonymous 12-step program, it’s not until you are willing to admit this aloud that you are on the road to recovery. But just knowing that problems exist is not enough to survive an FDA inspection.

Below are the various positions in which firms find themselves when the FDA comes knocking. You can decide which of these scenarios is the best possible position.

We know what our problems were, but they have been resolved

Let’s say an FDA investigator stumbled on a manufacturing work-order system that allowed changes to production equipment without a review by the quality assurance department on the effect the changes had on the state of validation. The best position to be in is to say that you were made aware of the problem, the system has been revised and employees trained, a retrospective review of maintenance work orders was conducted for product effect, and appropriate action taken.

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