The U.S. Food and Drug Administration (FDA) has introduced a new pilot program intended to increase the efficiency and effectiveness of its current inspection efforts.
Detailed in a press release issued by the agency in early May, the FDA’s one-day inspectional assessment pilot program consists of shorter, more focused screening assessments of facilities and operations for medical products and biologics, as well as clinical research programs and human and animal foods.
The FDA says that it has already completed 46 one-day assessments through April 2026, with most of those assessments confirming compliance and resulting in “No Action Indicated” (NAI) outcomes. Results from these and future one-day assessments will also help the FDA to develop more robust risk models, which the agency can then use to better align oversight activities with actual risks.
The one-day inspectional assessments are intended to complement, not replace, standard inspections, the FDA notes in its press release, and inspectors still have the discretion to expand the scope or extend the duration of an inspection if they deem it necessary. Further, the agency says that the pilot one-day inspection program does not represent a change in the FDA’s enforcement policy.
Read the FDA press release announcing the launch of its one-day inspectional assessment program.