Compliance & Regulation

Preparing for an FDA Inspection – Part 1

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This is part one of a two-part series. Part two is available here.

FDA Inspection

FDA inspections can be daunting, especially for an organization that is expecting its first one. In part one of a two-blog series, here are five best practices to prepare your organization for success:

1: Understand why the FDA will perform an inspection

The first step in preparing for a successful FDA inspection is understanding why your facility and Quality System (QS) are being inspected. Whether it’s a pre-approval inspection, a biennial audit, or for‑cause, knowing where the FDA will be focusing will help you focus on how to prepare.

2: Learn what an FDA Investigation is like

Another key understanding is that an FDA inspection is not just another audit. The inspection is not the same as an ISO 13485 certification audit, internal audit, or supplier audit. While not all FDA investigators are identical, in general, FDA inspections are much more rigorous and intense in nature.

Thus, educating yourself and your organization on what to expect during an FDA inspection is important. Many resources are available at the FDA’s website, including guides for medical device manufacturers and their Quality System Inspection Technique (QSIT). Another aspect to know is an inspection will assess compliance to 21 CFR 820 (the Quality System), as well as other parts, including 803 (MDR), 821 (Tracking), 806 (Corrections and Removals), and 807 (Registration and Listing).

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3: Identify Subject Matter Experts (SMEs) for processes and devices

Identify subject matter experts (SMEs) for QS processes and devices. These individuals should be knowledgeable with the subject matter, as well as able to communicate well with the investigator. While your organization’s records should speak for themselves, having an individual who can guide an investigator as necessary makes the inspection run more smoothly and efficiently.

4: Perform an assessment and address gaps

For an organization preparing for its first FDA inspection, review your Quality System procedures and records, with increased attention to the areas relevant to the anticipated focus of the inspection.

Many organizations also design their Quality Systems for ISO 13485 compliance, and while ISO 13485 and the FDA Quality Systems Regulations (QSR) are similar, there are some differences. Note, the FDA has indicated that harmonizing and modernizing the Quality System Regulation (QSR) with ISO 13485 is an active initiative. Until then, ensure your Quality System covers all aspects required by the FDA. One available tool that maps the FDA 21 CFR to ISO 13485:2016 is AAMI TIR102:2019.

Also audit your recent Quality Systems records for 2 reasons, 1) identify any issues for compliance to your organization’s procedures, and 2) familiarize yourself with any issues so they can be reviewed clearly by the SME if those topics come up in the investigation.  Use a reputable auditor that is familiar with FDA inspections and how investigators are trained. Involve your SMEs so they are prepared as well.

Records to review include those associated with the particular device of focus. For example, in a Pre-Market Approval (PMA) inspection, ensure an SME can walk an investigator through the Design History File of the device to demonstrate the design controls were adequately met. Before the FDA arrives is a good time to ensure that there is evidence that all design inputs are verified and all user needs and all intended uses have been validated.

Ensure that your firm is registered and that your device listings are up to date.

RELATED POST: Complying with FDA Design Control Requirements Using Requirements Management Principles

5: Perform mock inspection(s)

Mock inspections serve a number of purposes when preparing for an FDA inspection. They allow individuals that may be involved, including SMEs, an opportunity to practice, can identify areas of concern that can be addressed before the FDA arrives, and give your organization an opportunity to practice the logistics of hosting an FDA inspection.

Again, use an experienced auditor familiar with FDA inspections and the mindset of FDA investigators. 

As with any large endeavor, preparation is key. These best practices provide you with the path and resources to educate and prepare your organization for an FDA inspection.

Visit part two of this blog series for best practices and tips regarding the logistics of running a smooth and efficient inspection.

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Michelle Wu
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