FDA pilots one-day inspections

The US Food and Drug Administration (FDA) has announced that it is piloting one-day inspectional assessments, as part of a broader initiative to make its inspection resources more targeted and efficient. As part of this pilot, which launched in April, the agency is conducting 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. “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.”

One-day inspections also support the development of more robust risk models across FDA programs. Data gathered through these assessments — such as recurring compliance themes, facility-specific risk scores, and discrepancies between registered and actual operations — can be used to better target future oversight activities.

The pilot is being conducted across multiple FDA inspectorates, including human and animal foods, biologics, medical products, and clinical research programs. Facilities are selected using risk-based criteria such as product type, prior inspection outcomes, and operational characteristics.

As of late April 2026, the FDA has completed over 40 one-day assessments. Most 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.

The pilot will continue through fiscal year 2026, with FDA developing evaluation metrics to assess effectiveness, including inspection duration, escalation rates, and the utility of findings in informing risk-based decision-making.