FDA Inspections: When You Know You Have Problems

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.

It engenders confidence when an inspector can see evidence that a problem has been resolved and a product-effect analysis has been performed. It portrays the firm as being responsive to self-detected problems as a normal course of business.

We know what our problems are, we have a comprehensive plan, and we are executing the plan on schedule

A common strategy for firms that anticipate a warning letter or a consent decree is to have a third party conduct a thorough systemic audit and develop a comprehensive corrective action plan. It’s a way of saying to the FDA, “You can’t force us to do anything that we aren’t already forcing ourselves to do.” The plan is in writing, the deliverables are defined, reasonable target dates are established, responsibilities assigned, and management is tracking accomplishments vs. the plan.

This can diffuse an otherwise nasty inspection, because management is demonstrating that it is taking the initiative to deeply understand its state of compliance and holding itself responsible for timely results. The FDA inspector may still give you observations, but the establishment inspection report (EIR) will note the initiative you have taken. Also, the FDA may quibble over the plan’s scope or the timetable for completion, but it is far better to have the plan be the center of discussion than inaction.

We know what our problems are and we have a plan

The difference between this position and the one above is the failure to execute according to the schedule provided in the comprehensive corrective action plan. In my opinion, failure to execute is one of the most significant issues that separate the operational wheat from the chaff. Some companies just can’t get out of their own way to accomplish meaningful change. Administration substitutes for real work, team meetings substitute for personal accountability, and production schedules take priority over executing the comprehensive compliance plan. Something else is always more important. There is no discipline, no organization alignment, and no leadership.

It becomes evident during an FDA inspection that it is all talk and no action. FDA cites repeated observations from previous inspections. With FDA on record that there will be no multiple warning letters, this places you in the cross hairs of increased enforcement action.

We know what our problems are, but we have no plan

This is perhaps the most dangerous position to be in. Consciously not taking action when there are known problems is irresponsible. When faced with an issue during an inspection, you are either forced to say that you were not aware of the problem, or that you were aware of the problem and have not taken action. Neither response is very pretty. One is actually a lie.

This signals to the FDA inspector that current good manufacturing practices compliance is not considered to be important to the firm, and that the dots have not been connected between regulatory compliance and patient safety. To be clear, management is personally legally liable for knowing its problems and resolving them. This is a real slippery slope.

We don’t know what our problems are

What problems? This describes companies that rely on FDA inspections to tell them what the problems are, and the firm is always aghast to learn about the problems and ready to call someone on the carpet. This describes management that thinks an FDA 483 form with five observations is an improvement over the previous one with 10. This also describes the company that does not have established processes to take responsibility for the effectiveness of the quality management system, such as management review of quality system performance metrics, internal compliance audits, or just generally thinking that it is someone else’s job to worry about it.

You would be surprised at the number of senior management who can’t even tell you what their top five problems are. FDA calls this “inspecting into compliance,” and it has little patience for this unenlightened perspective. These are the bottom feeders in our industry.

So, which position would you rather be in during an FDA inspection when you know you have problems?

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