FDA refines strategy with one-day inspectional assessment pilot

The US Food and Drug Administration (FDA) is piloting one-day inspectional assessments to improve efficiency and narrow the focus of inspectional resources.

The initiative is not designed to replace the agency’s standard inspections, but instead act as a supportive tool in its overall strategy. It also helps the FDA to develop more robust risk models. Additionally, shorter, focused screening assessments will complement standard FDA inspections.

The move may help buffer the strain resulting from major staffing restructuring under President Trump’s current term, which includes Prasad’s exit as CBER Director last month.

Data gathered from these assessments, eg, recurring compliance themes, facility-specific risk scores, and discrepancies between registered and actual operations, aiding enhanced targeting of future oversight activities,

So far, the pilot has proven to be a flexible model, with some assessments extending beyond one day when significant observations were identified, FDA noted.

Launched in April, the pilot is expected to continue through fiscal year 2026, with additional assessments planned across inspectorates. As of late April, the FDA concluded approximately 46 one-day assessments, with most resulting in No Action Indicated (NAI) outcomes.

”We are closely analysing 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”

FDA Commissioner Marty Makary said: “One-day inspections can strengthen our inspectional approach by focusing our time and resources where they are most needed—enhancing our overall effectiveness.

“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 minimising operational disruption, particularly for lower-risk establishments.”

FDA’s Associate Commissioner for Inspections and Investigations, Elizabeth Miller, said: “We are closely analysing 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.”

In an earlier effort to improve its regulatory review processes, in February, the FDA opened PreCheck, another pilot programme. It is aimed at encouraging pharmaceutical companies in the US to build new manufacturing facilities.

Additionally, the agency recently made progress in implementing real-time clinical trials, set to advance development of promising therapies.