Implemented as part of a broader initiative to make more targeted and efficient use of inspection resources, the pilot program will use artificial intelligence to enable shorter, focused screenings to complement standard FDA inspections.
The FDA is piloting one-day inspections of simpler and lower-risk facilities to expand and strengthen its oversight.
Risk-based criteria such as the type of product, prior inspection outcomes and operational characteristics will inform facility selection. The FDA is using artificial intelligence (AI) to identify low-risk sites suitable for one-day inspections, Commissioner Marty Makary said at a Food and Drug Law Institute event attended by Bloomberg Law.
Conducting shorter, targeted assessments allows for broader surveillance coverage, enabling the FDA to “assess more facilities and gather critical insights without compromising regulatory rigor,” Makary explained in a statement. For the industry, the assessments “can provide timely feedback while minimizing operational disruption, particularly for lower-risk establishments,” he added.
Facilities involved with biologics, medical products and clinical research programs are eligible for one-day inspections. The FDA plans to run the pilot through its 2026 financial year, performing more assessments across inspectorates and developing metrics such as inspection duration and escalation rates to assess effectiveness.
The FDA will feed evidence collected during one-day inspections into its risk models. By evaluating more facilities, the agency said it could detect recurring compliance themes, develop facility-specific risk scores and find discrepancies between registered and actual operations to inform improvements to its oversight efforts.
While the FDA only disclosed the pilot on Wednesday, officials began performing one-day inspections last month and had completed 46 visits by the time the agency announced the program. Most one-day inspections confirmed the compliance of the facility, leading officials to conclude that no action was needed.
However, in some cases, inspectors made significant observations. When that happened, the inspectors extended their assessments to conduct multi-day evaluations. The switch from one-day visits to more traditional assessments shows the flexibility of the program, the FDA said.
Full FDA inspections of drug manufacturing facilities entail evaluating at least four of the six systems defined by the agency, namely quality, facilities and equipment, materials, production, packaging and labeling, and laboratory control systems. Inspectors must assess at least two systems in abbreviated site assessments.
How long the assessments take depends on what the inspectors find. Inspections that result in warning letters can span weeks, such as when FDA officials spent from June 23 to July 14 at a Catalent facility that Novo Nordisk acquired.
