As part of a broader initiative to make its inspectional resources efficient, FDA has launched a pilot for one-day inspectional assessments. What does the new program involve?

By Patricia Van Arnum, Editorial Director, DCAT, pvanarnum@dcat.org

A pilot for one-day inspection assessments
As part of a broader initiative to make its inspectional resources more efficient, the US Food and Drug Administration (FDA) announced this week (May 6, 2026) that it is piloting one-day inspectional assessments to complement standard FDA inspections. Under the pilot, which launched in April (April 2026), the agency is conducting shorter, focused screening assessments.

“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, in a May 6, 2026, agency release. “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.”

FDA says the one-day inspectional assessments 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 one-day inspectional assessments are not intended to replace standard FDA inspections, according to FDA. Instead, they serve as an additional tool to complement the agency’s existing approach. FDA says investigators retain authority to expand the scope or duration of an assessment if warranted. 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, according to the agency.

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, FDA had completed approximately 46 one-day assessments. Most assessments successfully confirmed compliance, resulting in “No Action Indicated (NAI)” outcomes. Under the full FDA inspection process, following an inspection, the agency evaluates the inspection findings to determines if the facility is in compliance with applicable laws and regulations and classifies the inspection. FDA has three classifications: NAI means no objectionable conditions or practices were found during the inspection. Voluntary Action Indicated (VAI) means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action. Official Action Indicated (OAI) means regulatory and/or administrative actions are recommended.

FDA says the pilot thus far has also demonstrated flexibility, with some assessments extending beyond one day when significant observations were identified.

“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, in FDA’s May 6, 2026, release.

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