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Jon Speer

FDA Compliance

What to Expect During an FDA QSIT Inspection

As a medical device manufacturer, you can expect to be inspected

Published: Tuesday, March 19, 2019 - 12:03

You arrive at work one morning, and there are FDA inspectors sitting in your waiting area. If you are lucky, you may be notified ahead of time that they’re coming, but otherwise, the US. Food and Drug Administration (FDA) is fully within its rights to show up unannounced at any time.

Because of this, your company must be prepared at all times.

In past articles, I’ve shared several ways in which you can plan ahead for inspections to ensure they go as smoothly as possible. But what if you’re past that point in the process? What if you get a knock on your door, and it’s a surprise visit from an inspector? I’m sure you’d like to know what will happen next, and what you should know in the moments after the shock and panic subside—both from an inspector’s point of view and your own.

Key terms to know for a quality system inspection technique (QSIT) inspection

As you’re probably well aware, the medical device industry is packed with confusing terms and cryptic regulations. For an FDA inspection, specifically, there are some important key terms and definitions you should be familiar with:

QSIT: quality system inspection technique
The “Guide to Inspections of Quality Systems” document is the set of protocols used by the FDA to conduct an inspection.

QSR: quality system regulations
The primary regulatory requirement being inspected by the FDA is 21 CFR Part 820.

QSR subsystems: A QSIT inspection focuses on four major subsystems of the quality system that establish the basis for what FDA inspectors will review:
1. Management controls
2. CAPA: corrective and preventive action
3. Design controls
4. Production and process controls

Other inspection-related regulatory requirements include:
21 CFR 801: Labeling
21 CFR 803: Medical device reporting
21 CFR 806: Reports of corrections and removals
21 CFR 807: Establishment registration and device listing
21 CFR 810: Medical device recall authority
21 CFR 830: Unique device identification

“As applicable” means that the regulations outlined must be followed as applicable to the specific organization and medical device.
Some regulations may not be relevant to you. For example, Class I devices do not require design controls. It is up to your company to determine what is applicable to you, perhaps with the assistance of a regulatory consultant.

There are also four different types of FDA inspections, and it’s important to know what each are for and how they’re conducted.

What to expect during a QSIT inspection

When an inspector first enters your facility, he should be greeted by someone whom your company has designated as the coordinator for the inspection. This person should be someone who can escort the inspector, help guide him to the information he’d like to inspect, and address any questions or concerns he may have.

Inspectors are required by law to show their credentials upon conduction of an inspection. You may choose to record those credentials by writing down the name and ID number, but it is prohibited to make any physical copies of the credential badge. All FDA inspections must begin by the agent presenting the company with an FDA 482 form, known as a notice of inspection. If you have not received one prior to the arrival of the inspector, he should provide you with one prior to the commencement of the inspection.

One of the first things to happen will usually be some kind of introductory meeting, where the inspector explains the purpose of the inspection (it will be one of the four main types of inspection, as summarized in the QSR subsystems bulleted points). You should also have a designated area that you’ve prepared for the inspector to use as a “base” from which to work.

The QSIT method

The QSIT method is a “top-down” approach to an inspection, which means that inspectors will generally begin by asking to see your procedures first, then drilling down further into your quality records. Your records are your proof; they should demonstrate that you are following your written procedures, supported by all ongoing activities. You can expect the inspector to ask for any or all of the following:
• To see your procedures
• To interview key personnel within your organization
• To learn more about your processes
• To review the records that back up your processes

The inspector may wish to take a sampling with him because it is not possible to review absolutely everything in one sitting.

If you are having a full routine inspection, you can expect that a Level 2 baseline QSIT will be conducted, which is a comprehensive review of all four main subsystems. This is often structured to take about four days, often with one subsystem inspected per day. You can expect that individual inspectors may have their own preferences, though—for example, one may want to spend more time on a particular subsystem.

How inspectors prepare for QSIT inspections

Inspectors will prepare ahead of time to visit your particular facility. If this is your first inspection, then they’re working from a blank slate or perhaps relying on information you submitted from a pre-approval.

If you have been inspected previously, an inspector will use that information to prepare for the next one. For example, he may look at:
• Previous reports
• Previous 483 observations or warning letters
• Previous responses to 483 observations or warning letters
• Your firm’s website and marketing materials
• Any consumer complaints or recalls that have occurred since the last inspection

What if an inspector finds an issue during a QSIT inspection?

If an inspector becomes aware of potential quality issues during the course of the inspection, he may wish to conduct a more detailed inspection of specific areas within your quality system. It’s worth having someone, aside from the person coordinating the inspection, who can be available to take notes.

This note-taker can record things like specific questions asked and documents that are inspected. This will prove to be very beneficial for reference later on in the process or at a future date. In addition, if you believe there’s a strong likelihood you’ll receive a 483 observation or warning letter, you can get a head start on rectifying whatever the issue is by this record-keeping practice.

You should also expect that every inspector is different. I often refer to the fact that FDA inspectors are only human, just like the rest of us. You can expect different levels of experience, different personalities, and different interests among inspectors. For example, one may pay much closer attention to a certain area than another; this often comes down to the inspector’s own experience and personal preference.

The closing meeting of a QSIT inspection

Once the inspector has finished with each area of the QSIT that she is there to observe, she will usually remain at the facility while she summarizes her initial findings. Once she has the final report, she will request a closing meeting with the company’s inspection coordinator and any senior-level managers.

During this closing meeting, the inspector may share her findings and indicate what may or may not result in the issuance of FDA Form 483—an official list of findings that the company needs to address. If there are any observations, the inspector will usually give the company the opportunity to discuss them and make any clarifications to defend its position.

At this point in the process, if you are presented with any findings that require future action on your part, you don’t have to agree to any specific actions or time frame. You can agree to correct those findings as part of your response to the official report. You have 15 calendar days from receipt of Form 483 to send a response to the FDA. If you fail to meet this deadline, it’s likely that those observations will be upgraded to a warning letter.

Of course, an alternative end result may turn out to have no observations at all, which is the ultimate goal! 

Once you reach the conclusion phase of the inspection, the report usually indicates one of the following classifications:
• NAI: No action indicated
• VAI: Voluntary action indicated
• OAI: Official action indicated

After the QSIT inspection

Following the quality system inspection of your medical device company, the inspector will write up an official Establishment Inspection Report and communicate all findings with his district. You can usually obtain an official copy of the report within 60 days.

If you did receive any observations, then you must respond within that 15 calendar-day timeframe; otherwise, you’re free to take any voluntary actions that were mentioned as you see fit, or carry on as you were. One of my preferences is to always look for the proactive steps you can take toward continuous improvement.

As a medical device manufacturer, you can expect to be inspected. If you’re lacking the infrastructure of a true quality system, it’s going to be very hard to take advantage of the free advice and resources available to help you prepare. Quality management system software with a dedicated audit management feature designed to meet the unique needs of medical device companies can make preparing for an inspection easier. You might even look forward to your next one.

First published Feb. 17, 2019, on the Greenlight Guru blog.


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.