Will FDA's One-Day Inspection Pilot Stand The Test Of Time?

By John W.M. Claud, Nelson Mullins Riley & Scarborough

On May 6, 2026, the FDA announced a pilot of one-day inspectional assessments, launched in April, as a shorter, focused complement to standard multi-day inspections. The pilot spans multiple inspectorates, including human and animal foods, biologics, medical products, and clinical research programs. FDA will select facilities using risk-based criteria that it has not yet published, such as product type, prior inspection outcomes, and operational characteristics.

By late April, FDA had completed 46 assessments, most of which resulted in No Action Indicated (NAI) classifications, though some extended beyond one day when investigators identified significant observations. At the Food and Drug Law Institute (FDLI) Annual Conference, then-Commissioner Marty Makary described the initiative as a “safety screening” informed in part by data provided to FDA’s AI tool, ELSA, saying the agency could use one-day inspections at lower-risk facilities to reach more facilities overall.

Less than a week later, Makary resigned under pressure, and Kyle Diamantas, the agency’s top food official, stepped in as acting commissioner. Less than a week after that, the director of CDER was ousted. No permanent replacements have been named.

Makary arrived at FDA with genuine bipartisan support, which is no small thing for a commissioner in this polarized era. But his tenure was marked by turnover, industry frustration with uneven regulatory signals, and a series of high-profile initiatives whose operational details often lagged the announcements. Several Makary-era programs were rolled out with considerable fanfare before the operational details were fully developed, and ELSA itself was launched in June 2025 on an accelerated timetable as the agency was also absorbing workforce cuts. By the time he used the FDLI podium to unveil one-day inspections, everyone affected was aware of the news reports that Makary might be fired. Makary himself referred to his job in the past tense at the conference, saying “It’s been a great ride.”

Even before Makary’s resignation, many in the pharmaceutical industry were questioning whether FDA still offered the level of regulatory predictability that companies had long relied on. If the one-day inspection program continues under new leadership, the more practical question becomes what an investigator can realistically accomplish in a single day. In many traditional inspections, the first day is largely devoted to safety orientation, facility familiarization, and the investigator’s preliminary review of operations. Compressing an entire visit into that timeframe assumes investigators have already completed substantial record review remotely in advance, meaning a few hours on-site would depend on several days of off-site preparation.

FDA has not published the specific ELSA inputs, weighting, or thresholds that identify a facility as “low risk,” which means industry has little visibility into how selection decisions are being made. The agency also has not released detailed protocols for these assessments, and until more facilities go through the process and more outcomes become public, the precise scope of a one-day assessment will remain uncertain.

FDA investigators have traditionally relied on extensive logistical support, much of which was significantly strained by the 2025 reductions in force (RIFs). At the same time the administration reduced FDA’s workforce by roughly 20%, it also announced this pilot program, which is intended to allow investigators to reach more facilities more quickly. And the RIFs are not the only personnel issue that could impair the pilot. A separate “Simple Reform” initiative announced in late 2025 would reverse the 2017 move toward product-specific investigator specialization and return the inspectorate to a more generalist model. One-day assessments demand the opposite: an investigator who can walk into a sterile drug manufacturer, a food production line, or a biologics facility and reach reliable compliance judgments in hours rather than days.

Meanwhile, FDA’s associate commissioner of the Office of Inspections and Investigations (OII), Elizabeth Miller, used notably careful language in announcing the pilot program: “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.” Miller is a career official whose continuity at OII may be the key to the pilot’s success, but the program’s evaluation data and metrics depend on what leadership above her decides to prioritize. For example, with an executive order already directing FDA to increase inspections of foreign manufacturing plants as part of a broader push for domestic pharmaceutical production, one-day assessments offer a ready mechanism to surge foreign facility coverage quickly. Where ELSA flags risk in the absence of published guidelines, a “screening” visit can turn into a full inspection before the facility ever knew it was a target. Under this scenario, foreign facilities may pay a “quality tax” in service of a policy that is ostensibly designed to certify the best players in the game.

For well-run facilities with consistent No Action Indicated (NAI) or Voluntary Action Indicated (VAI) classification histories, a one-day assessment means less production disruption, fewer days of management attention diverted to inspection management, and a faster path to closure. For FDA, the tool could also help address the agency’s long-term struggle to reduce its examination backlog. That said, as FDA develops metrics to weigh the program’s effectiveness during the trial run, the 46 early NAIs may be less revealing than they initially appear. Early pilots are often designed to succeed, and a sample of cooperative NAI facilities may not reveal much about how the program performs under real conditions.

Mature quality operations function with systemic regularity and redundancy that keeps facilities running smoothly, puts products on the market, and ensures patient safety. At an FDA where consistency of leadership has been hard to come by, the agency will need to find some of that same kind of consistency to prevent this pilot from slipping from another flashy announcement to another dead letter.

About The Author:

John W.M. Claud is a partner at Nelson Mullins Riley & Scarborough where he handles, among other things, matters related to warnings and untitled letters, consent decrees, and internal investigations. He's a former federal prosecutor and served as an assistant director of the U.S. Department of Justice’s Consumer Protection Branch. He began his career as an assistant district attorney in Manhattan. He is a frequent public speaker on matters of government enforcement strategies under the FDCA and corporate compliance best practices.