Insights From 250+ Regulatory Inspections

By Dan Schell, Chief Editor, Clinical Leader

Most of the people I talk to about FDA inspections either used to be behind the badge or have seen a few dozen audits up close. Elisabeth George stopped counting after 250. She didn’t just attend those inspections — she ran them. Not as a quality lead or as the person nervously defending CAPAs, but as the designated host responsible for orchestrating the whole production, often at Fortune 500 scale.

Hosting an FDA inspection isn’t just about setting out the right SOPs and hoping nobody overshares. It’s theater. There’s casting, scripting, blocking, and sometimes physical comedy (involving kicking your coworker under the table — more on that in a minute). When the curtain goes up, you’d better know your lines and hit your marks.

George spent nearly 25 years at Philips managing global inspections, from two-hour pop-ins to an eight-month saga at a U.S. facility during which she also flew to Germany and the Netherlands for separate inspections. She now consults with medtech and device companies of all sizes, preparing them to host their own regulatory shows — or triage the ones that went off script. With that kind of experience, she has some valuable tips on what your ClinOps team should be doing now, before the inspectors knock.

Be Meticulous In Your Planning For An Inspection

When the FDA shows up to a small clinical trial site, it’s usually one inspector, one room, and maybe one nervous site manager trying to find that training log from 2019. At a multinational device company like Philips Healthcare, that dynamic changes dramatically.

International audits often come with several months’ notice. Domestic inspections, not so much. But in both cases, you need to do a lot of homework and preplanning. For instance,

“You can absolutely profile an inspector by using resources such as LinkedIn, Google, and the FDA website,” she said. “Look at their 483s. Look at what product types they’ve audited. If a biologics inspector shows up to review your electromechanical device, you better be ready to give them a frame of reference right away — otherwise, they’ll go digging in all the wrong places.”

For European inspections, she took it a step further — mapping inspection schedules to human biology. “I always tried to get the second week,” referring to when FDA staff would plan three-week audit tours overseas. “The first week they’re jet lagged. The third week they’re exhausted from being there so long. But during the second week they’re sharp and still nice.”

George’s inspections often involved sprawling facilities, multiple product lines, and overlapping business units. As such, she emphasizes that you need to choreograph every aspect that you can, including who’s talking and who’s retrieving documents. Her suggested model includes a host that sits at the table with the inspector, controls the pace of the interaction, and never lets documents or people drift in unvetted. A trained notetaker or transcriptionist types live into an application such as Microsoft Teams, feeding updates to a command center in the back room. “By the time the FDA asks for a record, the back room likely is already pulling it,” she said.

She also recommended that someone from quality be present. That way, if she’s the host and talking to the investigator about a specific item, the QA person can look at that record or process and confirm it is exactly what was asked for and that it’s accurate. “More than once I've seen where the FDA asks for something like a sample of production records, and then somebody just goes and grabs the latest 10 and brings them in without ever looking at them. And then we find out that there are errors or missing information in those records.” Having that quality person involved can alleviate that problem from happening.

Know When to Speak and When to Shut Up

George’s most quoted piece of advice may sound like it belongs on a coffee mug: Answer the question that was asked — and only that. To put this into context, she recounted an inspection when a service manager started to go “off-script” during an inspection, answering a question that wasn’t his to answer, and wasn’t even the one that was asked. She was kicking him under the table, but he wasn’t getting it. Finally, she said to the FDA inspector, who she knew personally, “Can you turn your head for a second?” and then she slapped her hand over the service manager’s mouth and whispered, “Please shut the hell up!”

The inspector was laughing, but it worked. “It’s OK to say, ‘I’m sorry, that’s outside my area of expertise’” she explained. “Be prepared to sit in silence sometimes, because oversharing invites new questions, new document pulls, and often, new trouble.”

Final Notes

This is the fourth in my recent series of articles focused on regulatory inspections. The others are:

• Spiders, Mold, & SOPs: Tales From A Site Inspection Veteran
• Here's Your 483 — And Your Hug
• Why Perfect Clinical Trial Data Is A Dangerous Myth

(In April 2024, I also interviewed Patrick Stone, another former FDA inspector, for the article What To Expect From An FDA Inspection.)

While some of these include past inspectors recounting their favorite horror stories of inspections that went awry, my intent has always been to provide you with actionable and valuable information that can help prepare you for your next inspection.  

To recap this one, here are George’s most useful lessons for ClinOps professionals preparing for audits:

• Treat inspections like theater: rehearse, manage the cast, and control the script.
• Use the back room wisely: run live transcription, route all responses through one point of control.
• Research your inspector: background, specialty, and previous findings matter.
• Speak carefully: over-answers and off-topic commentary can derail you.

Don’t prepare for an audit like you’re prepping for a pop quiz; prepare like it’s opening night on Broadway. Adopting that mindset might just save you a few sleepless nights when the FDA shows up.