What to Expect When They're Inspecting

By Billy Delfs and Brynn Stanley

FDA Inspections Have Not Stopped Since the Government Shutdown

Since the shutdown commenced, there have been more than 70 Class I device recalls and 20 reported inspections. For-cause and scheduled inspections of device, drug, and biologic manufacturers have not stopped in FY2026, and neither have warning letters or recall enforcement. FDA Commissioner Marty Makary, M.D., M.P.H., has committed all available Agency resources to protect public health during the current government shutdown. For these reasons, the number of ongoing and open inspections will continue to increase in real time.

The Inspection to Recall connection

The FDA Investigations Manual discusses the process for assigning inspections in Chapter 7 – Recall Activities. When the FDA learns of a potentially violative product that may cause or has caused a Class I or a significant Class II recall, an inspection may be assigned to determine the root cause or causes of the problem (See Section 7.3.4). In carrying out these inspections, the Agency can be expected to focus on non-MDSAP sites, especially those with previous visits beyond the statutory frequencies. Sites registered as manufacturers of product approvals with high-risk classifications, such as Class III PMA medical devices and combination products are also included in this category. Distribution centers may receive lower priority for FDA inspection scheduling in cases where firms operate multiple manufacturing and specification developer establishments registered for on-market devices. In FY2025, our clients saw a renewed FDA focus on inspections of distribution centers to assess finished product controls. This shift is confirmed by the FY2025 medical device inspection data for establishments registered as “Repackager/Relabeler” in the Establishment Registration database.

An FDA focus on the non-MDSAP sites of medical device firms is reasonable because the Agency is not receiving records of notified body audits. MDSAP site registration is neither expected nor required for distribution centers handling domestic shipments.

Gardner Law encourages clients to implement programs for inspection preparedness. The program outline is a 3-P approach.

• Prioritize sites for targeting by external regulators
• Prepare the site for review and organize documents associated with expected requests
• Preserve the resources, training, and systems created within the scope of the inspection and audit plan

Prioritize, Prepare, Preserve.

P1: Prioritize

Firms can begin by creating an internal list of sites prioritized by business and compliance importance. This informs preparation efforts for the critical first step of FDA inspection readiness. Because inspection prep can interfere with ongoing business priorities, listing priority sites helps direct resources to likely inspection targets in advance.

Once the priority list is established, the preparation starts. The goal of any inspection, for companies and regulators alike, should be efficiency. This is accomplished by training individuals with quality system element ownership to interface with investigators or auditors, and by establishing an inspection support staffing plan.

P2: Prepare

The next step is subject matter training rooted in Agency foci. Fortunately, in the interest of transparency and collaboration, the FDA has made their internal inspection manuals publicly available. The standard for FDA inspections remains the Guide to Quality System Inspections Techniques, or QSIT (published 1999). The QSIT manual provides instructions for conducting quality subsystem inspections for medical devices. It is a joint publication between the Center for Devices and Radiological Health (CDRH) and the Office of Regulatory Affairs (ORA).

The QSIT manual contains series of investigational objectives and flowcharts specific to the quality system elements of 21 CFR Part 820. The majority of on-site inspection time is dedicated to Corrective and Preventive Action (CAPA) systems, Post-Market Surveillance, complaint investigations, and Adverse Event Reporting. Foundational inspection training should begin by distilling information from the corresponding chapters of the QSIT manual and then tailoring it to other FDA-regulated products outside of the medical device sphere. The FDA Reading Room, CDRH Learn, and CDER Webinars also allow industry partners to gain insight into the Agency’s perspective on critical topics.

"Inspections are a present reality. Being prepared is more than just a slogan; it’s essential to minimizing operational disruptions when faced with unannounced visits by regulators.”
–Billy Delfs, Associate Attorney, Gardner Law

P3: Preserve

The time and resources needed to accomplish the work described in the first two Ps are far from trivial. Supporting two auditors or investigators is estimated to require 25 people, four rooms (front and back rooms), and additional support from IT and facilities teams. Subject matter and general inspection training require a minimum of two hours; scribe training takes approximately three hours, and a comparable amount of time should be dedicated to facility walkthroughs. This does not include the time and resources needed to close compliance gaps discovered during preparation. Because inspection support plans are executed by the same individuals who create the documents and work products under review, staff allocations for inspection or audit preparation often negatively affect development timelines and the support of ongoing activities. Therefore, we recommend that firms create a means to preserve and display newly created materials, trainings, review lists, and staffing plans for adjustments instead of re-creations.

Thorough preservation enables organizations to scale their inspection prep programs to new product submissions, tailor them to continuous improvement initiatives such as onshoring, and quickly export them to OUS facilities with FDA’s expansion of unannounced inspections.

Uncle Sam may not be your only surprise guest. Manufacturers who distribute products in the EU need to prepare for spontaneous visits from EU Notified Bodies at facilities in the U.S. and abroad. EU MDR 2017/745, Annex IX, followed FDA's lead with a new unannounced audit requirement in paragraph 3. Now, notified bodies are required to conduct at least one unannounced audit every five years for all Class IIa, Class IIb, and Class III device manufacturing sites and critical suppliers.

Inspections aren’t something to dread; they’re your opportunity to shine! Instead of waiting for that unexpected knock, bring your team together, polish your processes, and get your compliance in top shape so you can welcome regulators with confidence. Proactive steps today turn surprise visits into moments to showcase your hard work. With Gardner Law by your side, you’ll be prepared, calm, and ready for whatever comes your way.
–Brynn Stanley, Associate Attorney, Gardner Law

How Gardner Law Can Help

Firms can transform inspection preparedness from a reactive scramble into a strategic advantage. Adopting proactive and structured approaches to inspection preparation by prioritizing high-risk sites, delivering targeted training and creating staffing support plans will ease the disruption of FDA inspections and Notified Body audits. With unannounced inspections expanding globally, the ability to stay inspection-ready is no longer optional; it’s essential. Gardner Law remains committed to guiding clients through this dynamic landscape with clarity, confidence, and compliance at the core.