The U.S. Food and Drug Administration (FDA) has announced the launch of a pilot programme for one-day inspectional assessments as part of an initiative to make inspectional resources more targeted and efficient. The pilot, which began in April, involves shorter, focused screening assessments to complement standard FDA inspections.
“One-day inspections can strengthen our inspectional approach by focusing our time and resources where they are most needed—enhancing our overall effectiveness,” said FDA Commissioner Marty Makary, M.D., M.P.H. “For the 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.”
The FDA stated that one-day inspectional assessments will also support the development of risk models across its programmes. Data collected through these assessments, including compliance themes, facility-specific risk scores, and differences between registered and actual operations, will be used to inform future oversight activities.
The pilot is being conducted across multiple FDA inspectorates, including human and animal foods, biologics, medical products, and clinical research programmes. Facilities are selected based on risk criteria such as product type, prior inspection outcomes, and operational characteristics.
As of late April 2026, the FDA has completed approximately 46 one-day assessments. Most assessments confirmed compliance, resulting in No Action Indicated (NAI) outcomes. Some assessments were extended beyond one day where significant observations were identified.
The FDA clarified that one-day inspectional assessments are not intended to replace standard inspections and will act as an additional tool within its existing framework. Investigators retain authority to expand the scope or duration of an assessment where required. The pilot does not represent a change in enforcement policy and does not apply to higher-risk or complex facilities requiring full inspection coverage.
“We are closely analyzing the operational and compliance data from these assessments—including trends in outcomes, risk signals, and investigator feedback to determine how this approach can enhance our broader inspectional strategy,” said FDA Associate Commissioner for Inspections and Investigations, Elizabeth Miller, Pharm.D.
The pilot will continue through fiscal year 2026, with further assessments planned across inspectorates. The FDA is developing evaluation metrics including inspection duration, escalation rates, and the utility of findings in risk-based decision-making.