FDA: Pilot Program for One-Day Inspectional Assessments
Since April 2026, the U.S. FDA has been piloting “One-Day Inspectional Assessments” as a complement to standard FDA inspections.
The initiative aims to make FDA oversight more targeted and risk-based by conducting shorter, focused assessments. According to the agency, this approach could expand surveillance coverage while reducing operational disruption for lower-risk facilities.
The pilot covers several FDA programs, including human and animal drugs, biologics, medical devices, and clinical research. Facilities are selected based on risk factors such as product type, operational characteristics, and previous inspection outcomes.
As of late April 2026, the FDA had completed approximately 46 one-day assessments, most resulting in “No Action Indicated” outcomes. The agency emphasized that the new assessments are intended to complement - not replace - standard FDA inspections.
Source:
FDA: Press Announcements
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