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Jon Speer

FDA Compliance

How to Prepare for an FDA Inspection

Five tips to help you get ready

Published: Monday, February 8, 2016 - 15:51

During the past several years, the FDA has been more aggressive and active in performing medical device company inspections. This has led to a far greater number of companies receiving Form 483 warning letters and citations. FDA Form 483s are a good way for your medical device company to flush $400,000 down the drain.

Has it been a few years since your last inspection? You know an FDA inspection will happen. An FDA inspector could call tomorrow and announce plans to visit your facility next week. Would you be prepared? What do you need to do to get ready?

I don’t have all the answers, but I’ve been through more than a few FDA inspections. With that in mind, I’d like to share five tips to help your medical device company get ready for an FDA inspection.

1. Your quality system will be reviewed during an FDA inspection

Medical device companies in the United States must demonstrate compliance to FDA 21 CFR Part 820—Quality System Regulations. This means your quality system must have documented, established procedures as defined in FDA 21 CFR Part 820.

Drafting procedures to comply with FDA regulations is one thing; making sure your procedures align with the company’s practices is another. During an FDA inspection, both the procedures and your actual practices will be reviewed and audited.

2. Use internal quality audits to your advantage

A great tool to help you fine-tune your procedures are internal quality audits. Performing internal quality audits may be a little scary at first, especially if your processes are newly established, but internal auditing helps to identify areas of concern and potential compliance issues.

You want your internal auditing program to be much tougher than the audit you’ll experience during an FDA inspection. Use internal audits for individual processes and for a quality system overview.

Try following the FDA Guide to Inspections of Quality Systems. It provides guidance on a new inspectional process called Quality System Inspection Technique (QSIT). The FDA will use a QSIT-style approach during your FDA inspection. The QSIT approach identifies a quality system based on major subsystems, as seen in figure 1. The FDA has well-defined checklists and guidance for QSIT. Use this to your advantage.

Figure 1: FDA QSIT subsystems. Click here for larger image.

3. Being certified to ISO 13485 is somewhat irrelevant

Many medical device companies pursue and obtain ISO 13485 certification. However, being certified to ISO 13485 does not mean you meet FDA quality system regulations (QSRs).

There’s a good chance you have been through a couple of audits for compliance to an ISO standard, and you may therefore have the impression that your quality system is in decent shape.

From the FDA’s perspective, this can be misleading, because the agency is concerned that you meet 21 CFR Part 820, which is FDA law. ISO 13485 pertains to European Medical Device Directives and is therefore irrelevant during an FDA inspection. Keep this in mind, but also realize that having one quality system to meet the requirements of ISO 13485 and FDA 21 CFR part 820 is definitely possible (and recommended).

4. Prep your team for the inspection

Aside from focusing on the quality system aspects in preparation for an FDA inspection, be sure to prep your employees and team members. No one looks forward to an FDA inspection. Usually when “FDA” is brought up in the medical device industry, people start to fear the worse. As long as you’re informed and prepared, however, you need not fear an FDA inspection. Yes, regardless of how prepared you and your team are, the FDA inspection will be stressful.

Incorporate mock FDA inspections into your preparations. Use them to coach employees on what to say and how to interact. Check into training courses. Seek others who have been through an FDA inspection. Ask if they would be willing to assess your preparedness. This preparation is just as important as anything else you can do to get ready for an FDA inspection. Knowing what to expect before it happens is helpful and will reduce the anxiety.

During your preparation, go through every aspect of what could happen during an FDA inspection, from the moment an FDA inspector walks through the door, to where to hold the inspection, to the composition of the staff (and back-ups) needed during the process.

Define roles and responsibilities before the FDA shows up. Coach your team on responding to questions during an FDA inspection. If an inspector asks a question, respond specifically to the question, nothing more. For example: “Do you have a complaint procedure?” asks the inspector. Your response: “Yes.”

It’s a little bit of a “dance,” but I encourage you to only answer directly what was asked.

5. Show time starts once the FDA inspector arrives

An FDA inspector will most likely call before an inspection, but he doesn’t have to. He could show up any moment.

When you’re notified of an FDA inspection (and hopefully it’s ahead of time), you’ll feel frantic. You’ll panic, at least a little. That’s OK, and to some degree, it’s expected. If you stay prepared, then you are ready for the FDA anytime. Conduct business as normal; don’t change your business practices just because of a pending FDA inspection. Don’t feel like every open CAPA, change order, and complaint file needs to be completed and closed.

If after doing everything you can internally to prepare, you still feel you’re not ready, that’s OK. Remember, you don’t have to dive in alone and hope for the best. It’s perfectly all right to have an outside resource act as the face of your company during an FDA inspection. I’ve served this role many times.

Once the FDA inspector arrives, it’s showtime. Discreetly let everyone know.

Greet the inspector and escort him or her to a designated room that is set up in advance. The inspector will give you a Form 482 Notice of Inspection. The inspector will also provide his or her credentials, including a badge (yes, the inspector is a federal agent).

Chances are the FDA inspector will ask for a tour of your facility near the beginning of the inspection. Assign a company employee to accompany the FDA inspector at all times. OK, if the inspector needs to use the restroom, don’t go into the stall, but do wait patiently by the door.

After the tour, the FDA inspector will dive right in. Don’t feel like you need to make small talk, even though the silence can be awkward.

As the FDA inspection progresses, the inspector will find issues that you need to correct. Don’t feel obligated to fix the issues during the inspection; you won’t get extra points. In fact, FDA discourages this practice.

If the FDA inspector has a question or makes an observation that you don’t understand, ask for clarification and an explanation. It’s better you understand what the issue is during an FDA inspection rather than guess days later.

You may not agree with some of the inspector’s observations. Do your best to state your case with supporting objective evidence. But do not be argumentative. Make your case, understand the comments, and move on. Remember, the FDA makes the rules and the FDA interprets the rules. You need to comply with the rules.

Always answer questions truthfully. Don’t try to answer based on what you think the FDA inspector wants to hear. Support your responses with records and documentation. If you don’t know the answer, it’s better to say, “I don’t know” than to make up a response.


About The Author

Jon Speer’s picture

Jon Speer

Jon Speer is the founder and vice president of quality assurance and regulatory affairs at Greenlight Guru, a software company that produces the only medical device quality management software solution. Device makers in more than 50 countries use Greenlight Guru to get safer products to market faster. Speer has served more than 20 years in the medical device industry and helped dozens of devices get to market. As a thought leader and speaker, he regularly contributes to numerous industry publications. He is also the host of Global Medical Device Podcast.