The previous entry in this series addressed that moment of panic you may feel when suddenly facing questions from regulators. This time, let’s talk about what to do when inspectors from a regulatory agency show up at your facility. Future topics will look at dealing with an FDA 483 and, shudder, an FDA Warning Letter. Let’s start with the inspectors.

If the inspectors have arrived at your facility, you must be involved with either making or testing a drug or device or  performing clinical trials for a drug or device that has been submitted for marketing approval. FDA inspectors do not generally just show up at your door. If they are there, it is most commonly by prior arrangement to perform an inspection to support a marketing application, also known as a  pre-approval inspection, or because your facility has come up for routine inspection. If, one day, you find FDA inspectors at your door with no notice, odds are that this is a for-cause inspection. This means that FDA has reason to believe that something is amiss at your facility and wants to investigate further in person.

Preferably, you will be preparing for a pre-approval inspection rather than an unscheduled visit by FDA. A pre-approval inspection is something to celebrate, as it indicates that the drug/device that you manufacture, test, or performed clinical trials on has reached the point of seeking marketing approval. The inspection itself can be a tense time for you and your staff as you answer questions from the regulators, but it is important to keep in mind how few drugs or devices actually get to this point. In this type of inspection, the inspectors are looking to make sure that you are doing things the right way. Of course, this is a generalization, but this is broadly true.

The inspectors are coming: preparing to host regulators at your facility

So, the inspectors are here. What do you do? What do you say? Well, here is an example of what not to do from a recent FDA Warning Letter, “During the inspection, your firm limited the investigator’s access to the quality control laboratory. The quality control manager directed employees to stand shoulder-to-shoulder, barring our investigator from accessing portions of the laboratory and the equipment used to analyze drugs for U.S. distribution.” It is no surprise that these actions led to a Warning Letter as well an Import Alert for the company that performed these actions.

Preparation is key. How do you prepare for an inspection? There are two key components to preparation. First, it is essential to understand exactly what it is that the inspectors are seeking. Second, consider conducting an internal inspection or partner with an external company (such as Pearl Pathways) to audit your facilities, quality system, etc. before the inspectors ever show up.

So, what is it that inspectors are looking for? They want to see how your facility operates, evaluate the training of your staff, and assess recordkeeping. They will ask for documentation, a lot of documentation. They’ll want to see your facility’s policies around the specific activities that they are inspecting and the Standard Operating Procedures (SOPs) that implement those policies. They will likely ask for recent examples of when something went wrong to see how the situation was handled. They will want to speak with some members of your staff to learn about their understanding of their roles and responsibilities.

Conducting an internal audit

When conducting an internal audit of your facility and its operations, try to ask the questions that a regulatory inspector might ask. It is far better that you identify a problem than to have it turn up under the eyes of the regulators. Oh, and by the way, of all the documentation that the inspectors can (and will) request, the results of your own self-audits are off-limits. They are not allowed to request information from your internal audit program.

Prepare your staff. Identify who will host the inspectors, accompanying them throughout their visit. Train your staff to answer questions simply and honestly, and to know when to stop talking. Determine who will be responsible for gathering the documents that the inspectors request.

Responding to an identified problem

What do you do when the inspectors point out a problem? It might be an outdated SOP, or a gap in your quality effort. Take a moment and make sure that you understand exactly what the issue is. If it is something that you can clear up quickly, e.g. by updating that SOP, by all means do so. If it is something that will take time and effort to address, now is the time to start planning (and budgeting). If you disagree with the inspector, don’t argue. Instead, present your case with careful reference to the regulations, showing that you are in compliance.

Take a deep breath. The inspection won’t go on forever, though it may seem that way, and the inspectors will eventually leave. And before they do, they will sit down with you to discuss their findings, summarized in FDA Form 483.

At Pearl Pathways, we partner every day with companies to help them prepare for inspections and address issues which arise as a result of inspections. The next blog in this series will deal with what to do when the FDA inspector hands you a 483. Check back to the Pearl Pathways blog soon to find out.