The U.S. The Food and Drug Administration has launched a new pilot program to carry out one-day, focused inspectional assessments meant to make food safety inspections more targeted and efficient, the FDA stated on Wednesday.
“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 a press release on Wednesday.
He added that the shorter, targeted assessments allow “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 pilot, which was first launched in April, will also allow the FDA to gather data about issues such as recurring compliance themes, discrepancies between registered and actual operations, and facility-specific risk scores, that can be used to create more targeted oversight activities, the press release stated.
The areas of inspection covered by the pilot include human and animal foods, biologics, medical products, and clinical research programs. The participating facilities are selected based on risk-based criteria, including product type, prior inspection outcomes, and operational characteristics, according to the FDA.
In addition, the FDA stated that the pilot program is flexible, and when needed, the assessments can be extended past one day. The assessments are not meant to replace standard FDA inspections and do not apply to higher-risk or more complex facilities that may require more comprehensive inspections.
By the end of April, the FDA had carried out approximately 46 one-day assessments, most of which demonstrated compliance and resulted in No Action Indicated (NAI) outcomes, the press release stated.
“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,” FDA Associate Commissioner for Inspections and Investigations, Elizabeth Miller, said.
The FDA stated that it is developing evaluation metrics to assess the effectiveness of the inspections and that the pilot is set to continue through the end of 2026.
Back in February, the FDA announced the launch of the Better Regulatory Inspections for Dynamic Government Efficiency (BRIDGE) project, which it says is meant to modernize domestic food facility inspections and strengthen coordination across federal and state food safety programs, the FDA said in a press release.
The initiative has been identified as a priority within both the FDA’s Office of Inspections and Investigations (OII) and the FDA’s Human Foods Program (HFP).
The FDA stated that the program will push a data-driven and risk-based approach to food safety oversight. Among other measures, it will use improved data sharing, aligned inspection planning, and stronger coordination.
The BRIDGE project is meant to support an approach to inspections that advances the Food Safety Modernization Act’s goal for an integrated food safety system.
In describing the importance of the project, the FDA said that it will help avoid duplication in oversight and that “as the food system continues to evolve, there is an increasing need for stronger alignment, shared risk intelligence, and coordinated planning. The BRIDGE Project addresses these challenges by optimizing FDA/State collaboration, improving how inspection, compliance, and risk information are shared and used, and aligning inspection activities so oversight efforts are focused where they are most needed.”
The FDA stated that the implementation of the project will be carried out in three phases, with proof of process ending in December 2027, followed by the national implementation period from January 2028 to December 2030.
The following goals guide the project, according to the FDA: