FDA Pilots One-Day Inspections for Lower-Risk Facilities, With 46 Done So Far

The US Food and Drug Administration is testing one-day inspectional assessments, shorter and more focused visits meant to let investigators cover more facilities, the agency announced on May 6. The pilot launched in April and runs alongside, rather than in place of, the agency's standard inspections.

According to the FDA, the assessments are being conducted across several of its inspectorates, covering human and animal foods, biologics, medical products and clinical research programs. Facilities are chosen using risk-based criteria such as product type, prior inspection outcomes and operational characteristics. The pilot does not apply to higher-risk or more complex facilities that need fuller inspectional coverage, the agency said.

Early results

As of late April, the FDA said it had completed approximately 46 one-day assessments. Most confirmed compliance and ended with a No Action Indicated outcome. Some assessments ran longer than one day when investigators identified significant observations, and the FDA said investigators keep the authority to expand the scope or length of any assessment.

"One-day inspections can strengthen our inspectional approach by focusing our time and resources where they are most needed—enhancing our overall effectiveness," FDA Commissioner Marty Makary said in the release. He added that the shorter visits allow "broader surveillance coverage" for the agency and, for industry, can "provide timely feedback while minimizing operational disruption, particularly for lower-risk establishments."

The agency said data from the assessments, such as recurring compliance themes, facility-specific risk scores and discrepancies between registered and actual operations, can feed risk models used to target future oversight. It stressed that the pilot "does not represent a change in enforcement policy."

AI to pick facilities

Speaking at the Food and Drug Law Institute's annual conference in Washington, Makary said artificial intelligence will help identify the low-risk facilities chosen for the shorter visits, Medical Design & Outsourcing reported. "The idea is we can do more inspections," he said, according to the publication, which also reported that the program covers facilities in the US and abroad.

The FDA said the pilot will continue through fiscal year 2026 with more assessments planned across its inspectorates. It is developing metrics to judge the approach, including inspection duration, escalation rates and how useful the findings are for risk-based decisions.

"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 Elizabeth Miller, the FDA's associate commissioner for inspections and investigations.