To better deploy field resources, FDA is kicking off a new pilot program under which regulators are leveraging “one-day inspection assessments” to supplement traditional field visits.
The new strategy, which aims to make the agency’s testing resources “more targeted and efficient,” relies on shorter, more focused test evaluations, according to a May 6 press release.
The data collected through the rapid assessment can be used to pinpoint recurring compliance themes, manufacturing facility-specific risk scores, and discrepancies regarding a facility’s registration practices, which could help coordinate future oversight efforts, FDA said.
The agency has been rolling out pilots since April across multiple focus areas, including human and animal food, as well as biologics, pharmaceuticals and clinical research programs, according to the announcement. Facilities for same-day inspections are selected using criteria associated with potential risk factors, such as product type, operational characteristics, and the site’s previous inspection history.
Bloomberg Law reported Wednesday that artificial intelligence is playing a key role in how the FDA targets evaluations, citing comments from FDA Commissioner Marty McCulley, M.D., at the 2026 Food and Drug Law Institute Conference in Washington, D.C.
“The one-day test is a screening test at a low-risk facility that our AI has determined is low-risk,” McCurry said, as quoted in the report. “The idea is to be able to do more testing.”
The FDA said it has conducted 46 of these one-day assessments since late last month, most of which were successful in confirming production and quality compliance, earning FDA inspection classifications of “no action.”
When key observations were made during FDA’s abbreviated facility visit, FDA noted that the program has flexibility to extend beyond the one-day period.
The regulator emphasized that the assessment “does not replace standard FDA testing,” but rather “supplements FDA’s existing approach.”
“Investigators reserve the authority to expand the scope and duration of evaluations when warranted,” the FDA clarified. “The pilot does not represent a change in enforcement policy and does not apply to high-risk or more complex facilities that require more comprehensive testing coverage.”
The testing program is expected to continue through the end of the year, and the FDA said it is developing metrics to weigh the effectiveness of the evaluations during the trial period.
Prior to the program’s launch last month, the FDA took another look at test results in March, releasing for the first time draft guidance (PDF) on how companies can best respond after receiving a Form 483.
If FDA identifies unfavorable conditions during a facility visit, a Form 483 will be given to the manufacturer, but these are observations only and do not represent FDA’s final conclusions regarding the facility’s compliance with good manufacturing practices.
While clarifying best practices may be helpful for 483 and new companies responding for the first time, the FDA’s decision to express expectations could also signal “a call to the industry that there will be increased regulatory oversight of testing,” Sonia Nath, head of law firm Cooley’s life sciences and healthcare regulatory practice group, told Fiers in a recent interview.
On the other hand, faster testing tools could actually be beneficial to the FDA, given the agency’s long struggle to reduce its backlog of on-site tests following the COVID-19 pandemic.
Early last year, there were growing concerns that the agency would struggle to meet its already strained testing workload after drastic cuts to the agency’s workforce under the second Trump administration, with the Department of Health and Human Services emphasizing at the time that the cuts were specifically aimed at saving testing staff.
