The FDA's One-Day Inspection Pilot Is Already Running
What we know about the new "inspectional assessments."
FDA Commissioner Marty Makary announced a new inspection pilot yesterday morning at the Food and Drug Law Institute Annual Conference in Washington. The FDA also made an official announcement on its website.
The agency has been conducting one-day “screening assessments” at select facilities across human and animal foods, biologics, medical products, and clinical research programs since April.
As of late April, the FDA has completed roughly 46 of these assessments. Most resulted in No Action Indicated outcomes. A few extended past one day when investigators found something worth looking at more closely. This is an additional tool, not a replacement for standard inspections. Investigators retain full authority to extend scope and duration if warranted.
Here’s what we know.
Before we jump in, if your site was among these first ~46 assessments, we’d love to hear from you. Send us a message at thefdagroup@substack.com.
How sites get selected
According to what’s known about this program, facilities are chosen based on product type, prior inspection history, and “operational characteristics.” The announcement also specifically called out discrepancies between what a facility has registered and what’s actually happening on the floor as a risk signal feeding into site selection.
The FDA says it plans to use data from these assessments — compliance patterns, facility-specific risk scores, operational gaps — to sharpen its broader risk models going forward.
What the FDA hasn’t published yet are the specific criteria that would classify a facility as low-, moderate-, or high-risk. That’s worth watching as the pilot continues through the rest of the year.
What investigators are probably looking at
We’re speculating here! They can only do so much in one day. Based on the FDA's description of the program’s purpose, a few items are likely to be on the list.
The registered-vs-actual operations check is likely central. It’s a fast confirmation: does the facility do what it says it does? That doesn’t require a deep records review, and it directly addresses one of the stated risk signals.
A facility walkthrough. More time-intensive, but if they do this, it probably involves a visual assessment of cleanliness, equipment condition, and general housekeeping, which takes a fraction of the day and surfaces obvious problems quickly — the kind that would justify converting a screening assessment into something longer.
Maybe limited records sampling focused on recent activity rather than a comprehensive historical review. Given the time crunch, investigators would likely look for active CAPAs with no closure, unresolved complaints, and gaps in critical documentation.
Prior 483 observations are another natural focus. If a facility had findings in its last inspection, verifying whether those issues were actually addressed is a targeted check that doesn’t require starting from scratch.
Beyond that, the specific focus areas will most likely vary by program. We’d guess that investigators will prioritize the highest-consequence failure points for the product type.
To be very clear, the FDA hasn’t released detailed protocols, and until more facilities go through the process and outcomes get published, the exact scope of these assessments isn’t fully known. The safest assumption remains that anything a standard inspection could catch is technically in play. The one-day format just limits how far they can go before they’d need to extend.
A few things to think about
Treat current inspection readiness as a baseline. A screening assessment that surfaces issues will likely become a full inspection. That's built into the program design. A few suggestions in light of this, none of which should be novel or earth-shattering:
Review your facility’s prior inspection history. That record is one of the explicit factors driving site selection under this pilot. It’ll give you some sense of where you might be on the FDA’s priority list.
Confirm that your registered operations match what’s actually happening on the floor. Discrepancies are flagged as a risk signal and appear to be an early focus of these assessments.
If your facility had 483 observations in a previous inspection, document your corrective actions clearly. Investigators have reason to check on those specifically, and that’s a fast task in a one-day format.
Talk to us if you’re overdue for an audit or mock inspection.
The FDA is building evaluation metrics — escalation rates, outcome trends, investigator feedback — to determine how the program evolves beyond 2026. We’ll report on those findings as they become available.
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