In a bid to better deploy its boots-on-the-ground resources, the FDA is pulling back the curtain on a new pilot program, under which the regulator is leveraging “one-day inspectional assessments” to complement its traditional site visits.
The new strategy, which seeks to make the agency’s inspectional resources “more targeted and efficient,” relies on shorter and more focused screening assessments, according to a May 6 press release.
Data gathered via the speedy assessments could be used to pinpoint recurring compliance themes, manufacturing facility-specific risk scores and discrepancies around sites’ registered operations, potentially helping tailor future oversight efforts, the FDA said.
Beginning in April, the agency is rolling out the pilot across multiple areas of focus, including biologics, medical products and clinical research programs, alongside human and animal foods, per the announcement. Facilities will be selected for the single-day examinations using criteria tied to potential risk factors, including product type, operational characteristics and the sites’ prior inspection track records.
Artificial Intelligence is apparently playing a key role in how the FDA is targeting the assessments, Bloomberg Law reported Wednesday, citing comments made by agency commissioner Marty Makary, M.D., at the 2026 Food and Drug Law Institute conference in Washington D.C.
“The one-day inspections are a screening inspection in low-risk facilities that our AI is identifying as low risk,” Makary said, as quoted by the outlet. “The idea is we can do more inspections.”
The FDA says it has conducted 46 of these one-day assessments since late last month, noting that most have resulted in successful confirmation of production and quality compliance, earning the agency’s “No Action Indicated” inspection classification.
When significant observations were made during the agency’s abbreviated facility visits, the FDA noted that the program has the flexibility to extend beyond the one-day timeframe.
The regulator stressed that the assessments “are not intended to replace standard FDA inspections,” but rather “complement the agency’s existing approach.”
“Investigators retain authority to expand the scope or duration of an assessment if warranted,” the FDA clarified. “The pilot does not represent a change in enforcement policy and does not apply to higher-risk or more complex facilities that require more comprehensive inspectional coverage.”
The pilot program is slated to carry on through the end of the year, with the FDA noting that it’s developing metrics to weigh the assessments’ effectiveness over the trial run.
Prior to the program’s launch last month, the FDA sought to tackle inspection outcomes from another angle in March, unveiling for the first time draft guidance (PDF) on how companies should best respond after receiving a Form 483.
Form 483s are handed down to manufacturers when the FDA identifies objectionable conditions during facility visits, but they are just observations and do not represent the agency’s final conclusion about an establishment’s compliance with good manufacturing practices.
While the articulation of best practices could serve first-time 483 responders and new companies well, the FDA’s decision to lay out expectations may also signal “a call to industry that there’s going to be increased regulatory scrutiny on inspections,” Sonia Nath, chair of the life sciences and healthcare regulatory practice group at law firm Cooley, told Fierce in a recent interview.
Meanwhile, a speedier inspection tool could indeed serve the FDA well, given the agency’s long-term struggle to whittle down its backlog of site examinations following the COVID-19 pandemic.
Concerns mounted early last year that the FDA might struggle further to carry out its already strained inspectional duties following massive cuts to the agency’s staff under the second Trump administration, though at the time, the Department of Health and Human Services emphasized that the downsizing effort was aiming to spare inspection staff specifically.