This is the third of our “Ask the Expert” blogs, a series featuring the wisdom and seasoned insight of Pearl Pathways Advisors and Consultant Advisors. Pearl Pathways Director of QA/RA Services, Beckinam Nowatzke, was interviewed for this piece.
If you have any regulatory, quality, or clinical development questions for Pearl Pathways’ advisors, forward them to us and we will provide answers in future posts.
From her 20-year career spanning biotechnology, pharmaceutical, CRO, and medical device industries, Beckinam Nowatzke, MSc, CBA, RAC has extensive experience managing medical device regulatory processes and compliance systems. She has been involved in multiple inspections: from device pre-approvals to good laboratory practice, from nonclinical to animal studies. Here, Becki offers firsthand practical advice toward preparing for and navigating an FDA inspection.
Q: Can you walk us through the first steps in preparing for an FDA visit?
A: I would say the first step is to run your quality systems as if you could have an audit at any moment. Make sure your quality system is built-in every day, because you might not get a lot of time to prep. Sometimes the FDA will give you a couple days’ notice—I’ve had them call on a Friday to say they were coming Monday. For nonclinical inspections, they just show up.
Also, make sure you establish a communication tree. Have your point of contact who’s going to meet the inspector in the lobby or at the door, have a dedicated space where you put the inspector. And then have a dedicated space—typically called the war room or prep room—where you put subject matter experts and document-control personnel, basically the people who will prepare documents the FDA is going to request.
Make sure all management and the entire site is aware that the FDA is present. Have communication that’s not available to the inspector but is available to the rest of the site so that they understand what’s going on at any given time. Let them know the proper code of conduct and the proper techniques to address the FDA’s questions.
Q: What are those techniques?
A: Never argue. It’s okay to say I don’t know; I’ll get back to you. Don’t guess. Don’t provide misinformation or try to skirt the issue. Answer the question directly. If you don’t understand the question, ask the inspector to rephrase it.
Make sure they finish their question before you answer—don’t jump in. One of the tricks a lot of auditors use, and particularly the FDA, is sitting in silence. They’ll ask a question, you’ll respond, and they’ll either stare at you or go back to looking through documents. People naturally want to fill that void, right? Inspectors want you to volunteer more information and maybe lead them somewhere else. So that’s one of my big ones: Just enjoy the silence.
And don’t let them go down rabbit holes, because they will try, and it could totally derail the whole inspection. I view particularly hard inspections like boxing matches: every day is another round. Sometimes you win; sometimes they win. The point is, you need to walk out of there the victor. Make sure there’s no scope creep, that they’re not looking at other product lines. Always with courtesy and professionalism, of course.
Q: Who should be part of the team when the inspector comes?
A: Obviously you want your CEO on site. For the opening and closing meetings, get your CEO and maybe your COO or CPDO. You don’t need to have the entire C suite. It’s really dependent on the type of inspection, but you want the highest level of functional leaders available.
Once the inspection happens, have your head of quality assurance (or whoever the lead inspection person is) and one or two scribes. You don’t want anyone else in that room. The more people involved, the more conversations happen, and it gets harder to keep track of all of it.
The ability of the scribe to keep track of everything that’s going on is essential because that’s our historical record. It tells us everything they requested, every question asked, every answer provided, and every person that came into the room. If there are multiple people and multiple conversations, that makes it much harder to have an accurate historical record.
Q: How long does the typical inspection take?
A: That’s up to the inspector. It also depends on the type of inspection. Typically, the inspector is not going to come in for one day and then walk away. Remember the news about the Johnson & Johnson vaccines? FDA came in to do a regular inspection and ended up staying for months because they found all these issues.
FDA is required to do an inspection every three to five years. If they find an issue, they may call more people to come and look at your facility. And inspectors can extend that inspection until they’re satisfied they’ve found all of the observations. If everything goes well it usually doesn’t last more than five days. There are some companies that are just under constant inspection.
Q: Is there anything else you’ve realized helps in establishing rapport with an inspector?
A: Cooperation is key. Don’t try to hide things or mislead. If I’m agitated and nervous, an auditor or an FDA inspector is going to wonder what’s going on here? Why so nervous?
If something’s wrong say, Yep. You’re absolutely right. Take accountability. Say, Yes, we’ll fix that. If there’s anything that you can fix before the inspection is over, try to fix it so it doesn’t end up being an observation.
It’s very important to develop some sort of relationship with the inspector right off the bat—you want to make them feel comfortable. This is true with any auditor but specifically the FDA because they already know they’re walking into an amped-up situation. What are things you might have in common?
I’ve bonded with FDA inspectors over twins, over Fitbit, over travel. Anything you can do to have those kinds of conversations helps. Sometimes those conversations make the time go a little bit faster while you’re trying to get documentation. If you establish a relationship where you can fill those voids, it makes it a more pleasant experience for everybody in the room.