Inside an FDA Inspection: What to Expect and How to Prepare

Introduction: FDA Inspections Have A Pattern

As someone who has worked closely with regulatory compliance teams, I know firsthand how nerve-wracking an FDA inspection can be—especially if it’s your first time. But over the years, I’ve learned that preparedness, transparency, and understanding the FDA’s approach can turn an intimidating process into a manageable one.

Let me walk you through the typical flow of an FDA inspection, especially for medical device companies governed by 21 CFR Part 820—the Quality System Regulation (QSR). From the moment the investigator steps through your doors to the final handshake (and potentially, a Form 483), knowing what to expect can make all the difference.

1. Pre-Announcement (If Applicable)

If you’re a domestic firm, don’t hold your breath waiting for a heads-up. Most domestic inspections are unannounced, in line with FDA policy. The goal here is to see the facility in its “everyday” operational state. However, if you’re overseas, you’re more likely to get a notification in advance. The FDA generally announces foreign inspections so companies can handle logistical and travel arrangements.

Source: FDA Inspection Guide

2. Initial Contact & Entrance Meeting

Once the investigator arrives, things move quickly. There’s usually a brief entrance meeting, where the FDA outlines the purpose, scope, and estimated duration of the inspection. This is the moment to clarify points of contact, align expectations, and ensure your team is prepared to support the inspection.

Pro tip: Have an inspection playbook or protocol ready—it keeps things smooth and avoids scrambling for documents.

3. The Role of the QSIT Guide

The FDA uses a risk-based model known as QSIT—the Quality System Inspection Technique—as their inspection framework. This guide helps the investigator determine compliance with 21 CFR Part 820 and focuses on the highest-risk areas first.

You can review the QSIT guide yourself here:

🔗 FDA QSIT Manual

Understanding QSIT will help you anticipate the investigator’s next move and prep the necessary documents in advance.

4. The Four Core Subsystems

FDA inspections usually dive deep into four major subsystems:

• Management Controls: How engaged is top management in quality? Do they allocate adequate resources and conduct meaningful management reviews?

• Corrective and Preventive Actions (CAPA): Is your CAPA process data-driven and effective? Investigators want to see root cause analysis, follow-ups, and real results. (Related reading: How to Leveraging CAPA for Actual Improvement)

• Design Controls: If your firm is involved in device design, this is a big one. Investigators will trace the product lifecycle from user needs through validation.

• Production and Process Controls (P&PC): How do you ensure product consistency? Expect a dive into process validation, equipment calibration, and manufacturing protocols.

Depending on findings, they may also review:

• Material Controls: Incoming inspections, supplier qualifications, and handling of non-conforming materials.

• Records/Documentation/Change Control: How well do you manage version control and updates to procedures?

5. Document Review & Observations

This is where the paper chase begins. Investigators will request specific records—think CAPA reports, complaints, validation data—and trace them through your processes. They’re looking for objective evidence that your systems work as intended.

Don’t be surprised if one record leads to three more. The key here is transparency and traceability.

6. Facility Walkthrough & Staff Interviews

Next up is the walkthrough—a hands-on tour of your facility. Investigators observe production lines, cleanliness, environmental controls, and often stop to interview employees.

Make sure your staff knows what to expect: they should answer questions honestly, stick to the facts, and defer if they’re unsure. No guessing!

7. Daily Wrap-Up (Optional)

Some investigators offer daily debriefs to share preliminary observations. These are informal and optional, but they’re incredibly helpful. You can address potential issues in real-time or prepare better responses for the formal closing.

If they don’t offer this, feel free to politely ask—it shows proactiveness.

8. Closing Meeting & Form FDA 483

The inspection ends with a closing meeting. If the investigator has found objectionable conditions, you’ll receive a Form FDA 483—a list of observations to review and respond to.

This is not an enforcement action, but it’s serious. A well-crafted, timely response (usually within 15 business days) shows your commitment to quality and can influence further action. An inadequate response to the observations could lead to an FDA Warning Letter.

More on Form 483:

🔗 Understanding FDA 483s

🔗 A Data Analysis of 3-Year FDA 483s

Conclusion

An FDA inspection doesn’t have to be a fire drill. With the right preparation, an understanding of the QSIT approach, and a commitment to continuous improvement, your team can face inspections with confidence rather than dread.

Personally, I’ve come to view inspections as a chance to showcase the robustness of our systems—and learn where we can do even better. After all, the ultimate goal is the same: ensuring safe, effective products reach the people who need them most.

Reference: Understanding FDA Inspections and Data

Related reading: Beyond Compliance: Leveraging CAPA for Actual Improvement

Related reading: A 3-Year FDA 483s Data Analysis

Published on: Apr. 11, 2025