If your facility is considered by FDA to be “lower risk,” you may be in line for a “one-day inspectional assessment.” In early May, FDA announced its launch of a pilot for shorter, focused screening assessments geared toward lower-risk establishments – for which it had already completed 46 one-day assessments in April.
What exactly is a “one-day inspectional assessment”?
It is essentially an inspection, but it is shorter and more focused “enabling timely feedback while minimizing operational disruption.” But it would not be wise to think of it as a sort of mini-inspection, as FDA made clear that “investigators retain authority to expand the scope or duration of an assessment if warranted.” Thus, an assessment would turn into a full-fledged inspection if serious non-compliances were found – as has been the case with some of the assessments FDA has conducted. While most have successfully confirmed compliance, resulting in No Action Indicated (NAI) outcomes, there have been some that have extended beyond a single day when significant observations were identified.
Despite this, it is important to understand that the assessments are not intended to replace inspections, but they do have the same potential outcomes, so do need to be taken just as seriously. While the goal of an assessment is for the inspector to be in and out in a single day, that will only occur if the facility is in compliance with all regulations or has only minor observations that are likely easily corrected.
The FDA has also noted that assessments will not be used at higher-risk or complex facilities, as these will still require comprehensive inspections. Rather, the goal is to complement standard FDA inspections; to help extend inspectional resources to enable the agency to assess more facilities without compromising regulatory rigor. Thus, facilities are selected using risk-based criteria, e.g., focusing on those with lower-risk product type, prior inspection outcomes, and operational characteristics.
Because it is a pilot, FDA is also using the data acquired from the assessments (such as recurring compliance themes, facility-specific risk scores, outcome trends, risk signals, and investigator feedback) to develop risk models and better target future oversight activities. And it is not just human and animal food facilities in the pilot, rather assessments are being conducted across the FDA realm at biologics, medical products, and clinical research establishments as well.
The pilot will continue through fiscal year 2026, with additional assessments and evaluation metrics planned to assess effectiveness, inspection duration, escalation rates, and the value of findings in informing risk-based decision-making.
The agency has not indicated if a facility would be informed of an upcoming assessment, or if these would be unannounced. In either case, being prepared at all times for an FDA inspection or “assessment” remains a key recommendation from TAG. Such preparation can — and should — include mock inspections. These inspection simulations, particularly when conducted by an external resource, can help a facility see its environment, practices, and processes through a different set of eyes and reveal areas or practices that are out of compliance — before they can become FDA inspection citations.
TAG provides mock inspections as well as risk-assessment reviews for facilities across the food chain. We can help ensure you are prepared for an FDA inspection or one-day inspectional assessment at all times.
