SILVER SPRINGS, MD — In efforts to create more efficient and direct inspectional resources, the FDA announced a pilot for one-day assessments across various inspectorates, including human foods.
“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.
This plan means the agency is conducting shorter, more focused assessments that complement the FDA’s standard inspections rather than replace them. Data collected during these concise evaluations includes recurring compliance themes, facility-specific risk scores, and discrepancies between registered and actual operations.
“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,” Makary said. “For industry, these assessments can provide timely feedback while minimizing operational disruption, particularly for lower-risk establishments.”
The FDA chooses facilities for one-day assessments on risk-based criteria, including product type, prior inspection outcomes and operational characteristics. Since its initial launch in April, the agency has completed more than 40 assessments, a majority of which resulted in “No Action Indicated” outcomes. This pilot program, which will run throughout the 2026 fiscal year, will be evaluated for effectiveness and the utility of findings.
“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, FDA Associate Commissioner for Inspections and Investigations.
In the past few months, the agency has issued a barrage of announcements, including opening comments for the definition of ultra-processed foods, evaluating the use of food preservative BHA, and redefining the meaning of “no artificial colors.”
“Food safety is the commercial baking industry’s top priority,” said Rasma Zvaners, VP of government relations for the American Bakers Association. “The American Bakers Association members are committed to maintaining rigorous safety and quality standards throughout the production process and comply with the FDA’s ‘Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food’ rule, as required by law.”
This program adds to the list of regulation-related considerations industry leaders are keeping a pulse on.
“The baking industry remains focused on providing consumers with safe, affordable, and high-quality food products while complying to regulatory frameworks that strengthen consumer confidence and protect public health,” Zvaners continued.
