Find out the top mistakes to avoid during regulatory inspections! You’ll discover how to improve your regulatory inspection experience for quality, clinical trials, FDA and EMA!
Regulatory inspections begin with your first contact from an inspector. Whether dealing with notified bodies or FDA, your professionalism and willingness to work with an inspector increases the likelihood of successful inspections, with little to no impact on your company and product approval.
Organizations want their regulatory inspections to go smoothly with zero findings. They want everything to go right from the moment the inspector arrives to receiving the inspector’s report, but it doesn’t always work quite that way. They often end up wondering how to avoid common regulatory inspection mistakes.
5 Regulatory Inspection Mistakes to Avoid
Here are common mistakes to avoid and what to do instead – whether you are dealing with FDA, EMA, or other notified bodies.
1. Trying to fill silence with more information
When speaking to an inspector, it’s normal for there to be moments of silence. It’s okay.
When you answer an inspector’s question, don’t feel compelled to keep speaking. Inspectors don’t always respond to your answers. They may even intentionally create a silent moment to give you an opportunity to become nervous and say a bit more than necessary.
Trust that if an inspector needs more information, they’ll ask you.
2. Giving false information
This might seem obvious, but it happens.
If you don’t know an answer to a question, don’t guess at the answer or make one up. Tell the inspector you don’t know the answer, but you will get it – and then get the information.
If you are not the subject matter expert (SME) for the question asked, explain this to the inspector and get the SME.
Certainly don’t give false information in an attempt to hide information about your clinical trials, manufacturing facility, or any other aspect of your company. If there is an issue, fix it before the inspection or have someone experienced with regulatory inspections support your team. (Find out how we can help you here).
3. Be defensive or argumentative
When responding to an inspector, refrain from arguing, making faces, or acting as if the inspector is stupid. Such behavior could suggest to an inspector that there is more going on and he/she needs to look deeper. More questions could be asked, more documents requested.
Instead, act confident and relaxed. Sit upright, smile and appreciate that the inspector has a job to do just like you.
4. Answering for someone else
When a co-worker is questioned, do not answer for him/her. You may be trying to help, but it is not your job. Allow your co-worker to answer. If there is an issue, address it at the end of the day or in the back room.
5. Ignore an inspector’s request for information
Inspections aren’t fun. They are exhausting and require long hours. It might be tempting to not pull all requested documents because you want to go home and go to sleep, but don’t do it. If an inspector asks for something, get it…
…and if the request is for something that could cause a finding, don’t be tempted to not provide the information in the hope that the inspector will forget the request. It won’t happen.
Do not make the inspector ask for information more than once. If it’s taking longer than expected to get the information, be courteous and let the inspector know when you expect to have it.
Summary
This list of mistakes and how to avoid them might seem like a lot of information, but it’s all things that can help your organization have a more successful regulatory inspection. Hopefully, you now feel better equipped for a regulatory inspection.
If you need more help, please contact us to discover how we can help you with inspection readiness preparation, management and support during an inspection, and with resolving inspection findings.