Imagine you’re a student trying to pass a challenging class, one where the entire grade rests on the big test at the end of the semester. Fortunately, the professor handed out a syllabus that outlines exactly what will be on that final exam. Better still, you can also find a posted list of common mistakes previous test-takers made.

Given those resources, what are the chances you would still fail? Unlikely—unless you never bothered to study the material. In that case, you’d be like me trying to explain quantum mechanics after one five-minute YouTube video. (Spoiler: It didn’t go well.)

This is the reality of FDA inspections for companies in the life sciences. The federal agency effectively publishes its “syllabus” through regulations and guidance documents, while also releasing lists of common pitfalls companies face each year—documented as Form 483 observations. In spite of those resources, many companies still find themselves scrambling when inspectors knock on the door.

Preparation is the key difference between companies that pass inspections and those that receive hefty citations. Developing an “audit culture”—where compliance isn’t a periodic scramble but a foundational business practice—will help you get there.

Preparation starts long before the auditor arrives

Nothing clears a conference room faster than the phrase “the FDA is here.” It’s the corporate equivalent of yelling “Shark!” at a beach party. Papers start flying, coffee is spilled, and someone inevitably asks, “Do we even have a quality manual?”Nothing clears a conference room faster than the phrase “the FDA is here.” It’s the corporate equivalent of yelling “Shark!” at a beach party.

Although the initial wave of panic is understandable, it doesn’t have to turn into full-blown chaos. The truth is, an FDA inspection doesn’t have to feel like a surprise audit from the boogie man. With the right preparation, clear documentation, and a culture of compliance, that heart-stopping moment can become just another day at the office (minus the caffeine-induced hysteria).

Start by putting yourself in the inspector’s shoes: You need to inspect what you expect. An audit culture at the company develops when your team knows you will check to make sure proper protocols are being followed. If you don’t inspect it, people don’t know you (and the FDA inspector) expect it. Employees can read the SOP, survive the accompanying two-hour in-person training, and nod like they understand, but it’s not until they’re face to face with you (or an inspector) that they realize, “Oh… this is why it’s important.” Internal site walks that mirror how an inspector will look through your facility will reveal potential issues before they become 483 observations. Your goal is to find the weakness before the FDA does.

In my experience, FDA inspectors typically ask questions that relate to both the applicable regulations and their real-time observations during the site visit. That’s why it’s essential to thoroughly review the relevant FDA regulations applicable to your organization ahead of time. Know what applies to your operations, how you’re meeting those requirements, and be ready to explain it clearly. A little time spent with the Code of Federal Regulations (CFR) today can save a lot of sweating tomorrow.

This means a company can prepare for approximately 80% of what will appear on the inspector’s report. The remaining 20% will depend on a variety of factors, including the inspector’s specific expertise or focus areas. By conducting mock audits and thorough internal site walks, checking processes against the CFR and your internal procedures, you prepare for that predictable 80% and drive home the idea that inspections are standard practice. It helps your team see inspections less like surprise pop quizzes and more like routine dental checkups, slightly uncomfortable but totally manageable if you’ve been flossing.

Preparing your personnel for the inspector’s questions is equally important. Untrained employees might inadvertently create problems during inspections by providing unnecessary information or simply failing to answer questions directly. Along with regular site walks, conduct mock interviews to ensure staff know how to interact appropriately with inspectors. Even the most compliant operation can go sideways if an untrained employee starts oversharing or goes off-script. A well-intentioned detour into “how we used to do it” can open doors no one asked to walk through.

Think of it like this: The inspector wants a guided tour, not a choose-your-own-adventure. Train your team to listen carefully, answer directly, and resist the urge to fill silence with nervous trivia or rambling. A calm, confident response shows you know your processes and keeps the spotlight where it belongs: on your compliance, not your improv skills.

Addressing issues should be proactive and ongoing

Of course, passing inspections shouldn’t be the primary reason your company focuses on product quality or safety. The FDA mandates that regulated companies maintain CAPA (corrective and preventive action) systems that help address problems after they arise. Each company must develop and implement its own specific processes.Passing inspections shouldn’t be the primary reason your company focuses on product quality or safety.

Despite this clear imperative, CAPA system failures frequently appear on the FDA’s list of common 483 observations. Many companies fail not because they have problems, but because they don’t properly identify, document, and address those problems through their CAPA program.

During inspections, I’ve found that auditors will ask detailed questions about your list of issues and drill down on your CAPAs for each instance. Inspectors don’t need to go digging for problems; they’ll let your own documentation do the talking. In fact, they’ll challenge you through your CAPA system, testing how well you’ve addressed known issues by holding your past work up to the light. It’s like being quizzed with your own notes, except they’ll notice if you scribbled “We’ll fix this later” in the margins. That’s why it’s crucial to ensure that documentation is not only completed or processed on time, but also well-reasoned, justified, and ready to stand up to scrutiny. Because if there’s a weak spot, the inspector will find it, circle it, and ask you to explain it.

However, auditors generally don’t ding you just for one problem that pops up; they are more focused on if you properly fixed them. One of their biggest concerns is when the same issues recur, suggesting you’ve either misunderstood the root cause or have failed to take corrective actions. When the same issue keeps showing up, it’s a sign you’re treating symptoms, not the cause. You need to get to the root before it comes back for an encore that no one wants to see or hear.

Ensure you have solid, up-to-date documentation and electronic systems

Documentation has always been the foundation of every audit in which I’ve participated. During inspections, your ability to quickly provide accurate, complete records can make the difference between a minor observation and a significant finding. When your paperwork is in order, inspectors spend less time digging and more time nodding in approval.

This is where technology changes the game. Electronic systems reduce human error, enable rapid information retrieval during inspections, and integrate across business functions. A well-designed electronic system connects complaints to investigations, investigations to CAPAs, and CAPAs to training—creating a closed loop of continuous improvement that might even make an inspector crack a smile (rumor has it they do this from time to time).

Even though it’s a significant expense up front, companies should invest in electronic systems for the time and effort saved when addressing CAPA issues and during inspections. Outdated procedures and improper documentation regularly appear on 483 observations; electronic systems help reinforce your audit culture and help ensure documentation remains current and accessible.

The time to prepare for FDA inspections isn’t when you receive notification of an upcoming audit. It’s now, through ongoing vigilance, robust quality systems, and a culture that embraces regulatory compliance as a business advantage rather than a burden.

By understanding what inspectors seek, proactively addressing issues, and maintaining comprehensive documentation, you transform the inspection from a dreaded event into a predictable, manageable process. So, treat FDA inspections like that class final: Study the syllabus, keep your materials organized, and have your cheat sheet close. If you do, you just might breeze through the inspection—or, at the very least, keep your panic to a low simmer instead of a furious boil.