FDA Announces Pilot of One-Day Inspectional Assessments

The Food and Drug Administration announced today that it is piloting one-day inspectional assessments as part of an effort to make oversight activities more targeted and efficient. The pilot, which launched in April, uses shorter, focused assessments to complement standard FDA inspections.

According to the agency, the assessments are intended to expand surveillance capacity while reducing operational disruption for lower-risk facilities. FDA Commissioner Marty Makary, MD, MPH, said the approach allows the agency to focus resources where they are most needed while maintaining regulatory rigor.

The pilot includes multiple FDA inspectorates, including biologics, medical products, human and animal foods, and clinical research programs. The agency selects facilities using risk-based criteria such as product type, operational characteristics and prior inspection history.

According to FDA, 46 one-day assessments have been completed as of late April, with most resulting in “No Action Indicated” findings. The agency noted that investigators may expand the scope or duration of an assessment if significant observations are identified.

FDA emphasized that the pilot is not intended to replace standard inspections or alter enforcement policy. The agency plans to continue the pilot through fiscal year 2026 and is evaluating metrics to assess effectiveness, including inspection duration, escalation rates, and the utility of findings in informing risk-based decision-making.