10 Troubling Thoughts An FDA Inspector May Have At Your Biopharma Company

By Laurie A. Halloran, BSN, MS,  President & CEO of Halloran Consulting

Have you ever wondered what is going on in the mind of an inspector? While you cannot know ahead of time, the process is going to be significantly more positive if you make an effort to see the inspection from their vantage point. This will help you recognize the right and wrong way to start and manage the relationship. Unfortunately, you don’t have a choice on who your FDA inspector will be, but there are some important things to keep in mind to minimize the challenges of an unannounced visit. 

1.  “I really don’t mind accommodating people’s schedules, but putting me off a month…”

According to the Compliance Program Guidance Manual, the field investigator should immediately report to the Center contact any attempt by the sponsor/CRO/monitor to unduly delay an inspection by more than ten working days without sufficient justification.  By delaying an inspection, it could turn into a “for cause” inspection and that will change the whole tone of the inspection.  Remember, FDA can just show up with a Warrant.

2.  “How long are they going to keep me waiting in Reception?”

If the Inspector is kept waiting too long at Reception, they can assume that you have something to hide and that you are scrambling to hide things.  This could also change the tone of the inspection and make for a grumpy inspector.

3.  “Wow, what a treat to be able to go to the bathroom by myself!”

We strongly recommend you never let an FDA Inspector be unescorted, for they have been known to roam into other areas of the building as well as try to open file cabinets.  This potentially could open up your BIMO inspection into other areas as well as broaden their scope which will prolong their visit. In the case of the bathroom, your vigil must continue. Un-briefed employees (pardon the pun) with abandoned notebooks are a bathroom hazard. We recommend you scout out the bathroom to make sure less-than-desirables aren’t present, then respectfully remain outside the bathroom (ready to resume your escort).

4.  “This SME won’t look me in the eyes, hmm.”

FDA Inspectors are trained similarly to FBI agents in the science of reading body language and drawing conclusions.  A lack of eye-contact when being interviewed can give the impression you have something to hide.

5.  “I asked for that document over an hour ago!”

The inspector will time and record their request for a particular document to see how long it takes you to produce it.  If it takes longer than they would expect, they could think that you are creating the document. This is why all study documentation needs to be readily available and accessible during the inspection.  If your File Room is in a different building than where you plan to host the inspection, it may be prudent to pull all study files in advance and stage them in a temporary room closer to the “Front Room.”

6.  “If I hear one more time ‘It was not my job’…”

Pointing fingers and casting blame on others in your organization can give the impression of a lack of accountability and clear roles and responsibilities.  Without this clarity, an inspector could draw the conclusion that the study was not well controlled.

7.  “These study files look awfully clean and perfect, hmm.”

FDA assumes that study records are not going to be pristine because there are so many different flawed human beings involved in clinical research spanning several years.  If the documents look too perfect, they may think you just recently created them!

8.  “I wonder if they can explain this drug and the study design to me in ‘layman’s terms?’”

Many FDA inspectors do not have a medical or clinical research background.  Being able to explain complex diseases and therapies as simply as possible will demonstrate you have a solid understanding as well as minimize FDA from misunderstanding and jumping to conclusions.

9.  "This was an issue last time I was here, and they swore they were going to do X, Y, and Z to correct it.”

Often you will get the same regional inspector for subsequent inspections and they always review past inspection findings before they come again.  Follow up to ensure you implemented the corrective actions you said you would otherwise everything you say at this inspection could be viewed as suspect.

10.  “Please don’t make me speak to this same person again. I want to talk to the person who actually did the work!”

If you keep putting the same subject matter expert (SME) in front of the inspector and their questions are not answered satisfactorily, FDA could think you are hiding something or protecting someone.  Try to read the inspector’s demeanor and provide the person or role that they ask for.  Having just one person answer all questions could be interpreted as a lack of qualified people working on the study.  Remember, FDA can ask to speak to anyone.

Inspectors are trained to look for the things that aren’t said and aren’t done, but that doesn’t mean you should send in unprepared people who may babble or answer questions inappropriately or share more than necessary. Don’t skip conducting an “open kimono” gap analysis where the entire team can be prepared on how to respond to questions appropriately, regardless of whether you feel there are issues with the study conduct or not.  It’s an exercise meant to prepare your team so they are comfortable and confident in the process ahead.

We have covered inspection preparation to-date in our blogs “Do’s and Don’ts” and “The First 100 Minutes.” Next we will cover what triggers an inspection. The key is to understand the likelihood of one occurring to allow a sensible use of resources to prepare appropriately, while not over-preparing in a way that would risk exhausting your team.

Laurie Halloran founded Halloran Consulting Group in 1998. Her vision in forming the company was Life Science that Works: Product, Process and People. She realized through working with early stage biotechnology companies that senior level expertise is critical at early stages of navigation through the regulatory and operational challenges of product development. She has built a successful consultancy of likeminded experts who are dedicated to the idea that every company deserves the best practices and know-how in the life science world, regardless of its size, its name or its financial situation. She is recognized as an industry expert in improving the organizational effectiveness of those companies.