Tips to Prepare for Your Next FDA Compliance Audit (Don't Forget CFR Title 21)

August 15, 2019
February 3, 2020

Medical device manufacturers are facing more FDA scrutiny of their quality systems than ever before. In the last decade, the quality systems elements with the most FDA observations have consistently been P&PC, CAPA and Design Controls. In 2017, P&PC and CAPA subsystems alone accounted for 34% and 33%, respectively, of the total 483 observations issued by the FDA, followed by Design Controls with 13%.

But many companies haven’t been audited in years. It’s common for organizations to have an “If it’s not broke, don’t fix it” attitude toward quality. Unfortunately, this attitude can cost them millions of dollars in remediation costs when the FDA does inevitably come calling.


If your last audit was years ago, you may wonder if things have changed or what to expect. And if you’ve had recent audits with poor results, you may be seeking a way out of the costly cycle your business is trapped in. Either way, you need a prep strategy to reduce your FDA compliance risk. Use this guide to help your business approach your next FDA audit with confidence.


How to prepare for an FDA medical device audit.

  1. If you don’t have well-documented and established procedures in place, start working on that today. It is critical to not only show your compliance with FDA Quality System Regulations but also to demonstrate how your company implements those procedures on a daily basis.

  2. There’s no reason to go into an official FDA audit blind to issues that could arise. Conducting regular internal quality audits is the only way to get a clear understanding of your audit risk ahead of an official audit. Track your results on a constant basis so you can keep the focus on areas that need improvement.

  3. Get familiar with this handy FDA guide to QS systems inspections so you know what to expect ahead of time. This is a great tool to use when designing your own internal audit process, and for preparing your team to handle an audit.


What to expect during an FDA medial device audit inspection.


  1. Surprises happen. In a perfect world, you’d have prior notice that an FDA inspector will be coming. This is not required, so a surprise inspection could happen at any time. Of course, once they arrive they are required to identify themselves -- they won’t be conducting any ‘sneak’ inspections without your knowledge.

  2. It’s best to inform the rest of the company when an FDA inspector has arrived.

  3. The inspector will give you a 482 Notice of Inspection form outlining what they may inspect during the visit, and then the inspection can begin.

  4. Don’t leave the inspector alone to wander -- make sure you or another representative is guiding them through the work area and available to answer questions.

  5. The inspector will most likely identify a few issues. The best way to handle this is to confirm that you will resolve the issues as soon as possible. Be gracious and take criticism with an open mind. Don’t give in to the impulse to explain or make excuses for an issue. Just focus on solving the issue. Feel free to ask any questions necessary to clarify the inspector’s comments so you don’t have to guess at anything after the inspection.


4 Tips for passing an FDA medical device audit.


  1. Make sure you’re up to date on the specific requirements you must meet. For example, ISO 13485 is a common target for medical device manufacturers aiming to pass an FDA quality systems inspection, but it’s actually not enough to pass on its own -- it’s equally important to meet the requirements of 21 CFR part 820.

  2. Get professional help with your internal auditing process. Especially if it’s been a while since your last quality systems inspection, a third party can offer you a well-rounded and unbiased view of your compliance risk. Even better if you can find experts in FDA quality systems compliance who can offer an easy to understand visualization of your compliance risk data, so you always know exactly where you are and what to prioritize. Onebridge offers this exact expertise, here’s an example of a compliance risk dashboard we could create for you: [image of dashboard]

  3. Empower your auditor. Whether internal or external, finding quality systems issues during an internal audit means nothing if your auditor can’t get changes made to fix the issues. Commit to supporting the changes that need to be made.

  4. Inspire your colleagues to put quality systems first. Click here to learn more about building a culture of quality within your organization.


We’re here to help!

With over a decade of industry expertise, Onebridge provides a structured, risk-based approach to assessing the health of your Quality System. Our people have an extraordinary level of expertise with all aspects of quality and compliance and have worked hand-in-hand with hundreds of companies to diagnose, solve, and prevent quality issues. 

Our quality and compliance team offers more than 2 decades of experience in Life Sciences with a special focus on FDA requirements and quality systems. Our data visualization experts also offer simple, easy to read dashboards that completely revolutionize the way you share quality data across your organization.

Through an exhaustive compliance assessment of the current state of your Quality System, we can visualize your data to diagnose the health of the system and help you make better decisions that provide early treatment options for any symptoms detected.

After all, more compliance efficiency can lead to an increase in time to focus on your long-term goals. Your business goals and expectations are built directly into the treatment options we offer to mitigate any compliance risk we identify and establish solutions that are sustainable through time.


Interested in learning more about how this works? Check out our Quality & Compliance homepage to learn more about us and Download our free FDA Quality Systems Enforcement ebook. You’ll learn everything there is to know about how the FDA handles the compliance inspection process and see how, using specific data points, we can visualize the health of your system, show you exactly what changes are needed, and prioritize those changes so you reach your goals faster. 

With information about your organization’s quality systems health available in simple dashboards, creating a company-wide culture of quality first becomes much easier. We’d love to hear about your goals and challenges and help in any way we can -- contact us today.

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