These assessments are not intended to replace standard FDA inspections. Investigators retain the authority to expand the scope or duration of an assessment when warranted.

“One-day inspections can strengthen our inspectional approach by focusing our time and resources where they are most needed—enhancing our overall effectiveness,” explained FDA Commissioner Marty Makary, M.D., M.P.H. “For FDA, the ability to conduct shorter, targeted assessments allows for broader surveillance coverage, enabling the agency to assess more facilities and gather critical insights without compromising regulatory rigor. For industry, these assessments can provide timely feedback while minimizing operational disruption, particularly for lower-risk establishments.”

Piloting began in April and will continue through fiscal year 2026, and includes human and animal foods inspectorates, as well as biologics, medical products, and clinical research programs. Facilities are being selected for the pilot assessments using risk-based criteria such as product type, prior inspection outcomes, and operational characteristics.

As of late April, FDA has completed approximately 46 one-day assessments. Most assessments successfully confirmed compliance, resulting in No Action Indicated (NAI) outcomes. The pilot has also demonstrated flexibility, with some assessments extending beyond one day when significant observations were identified.

The pilot does not represent a change in enforcement policy and does not apply to higher-risk or more complex facilities that require more comprehensive inspectional coverage.

FDA is currently developing evaluation metrics to assess the effectiveness of one-day inspectional assessments, including inspection duration, escalation rates, and the utility of findings in informing risk-based decision-making.