backOn May 6, 2026, the Food and Drug Administration (“FDA” or “the Agency”) issued a press release officially announcing a pilot program for one-day inspectional assessments.1FDA News Release: FDA Launces One-Day Inspectional Assessments to Strengthen and Expand Oversight, dated May 6, 2026. According to the press release, FDA quietly started these one-day inspectional assessments last month. The assessments permit FDA to conduct shorter, focused assessments to complement standard FDA inspections. FDA will continue to rely on traditional, multi-day inspections in many cases, especially for initial site inspections under a pre-license or pre-approval paradigm and for-cause inspections. The one-day assessments are considered an additional tool to complement existing compliance approaches and, according to FDA’s press release, the pilot program does not represent a change in enforcement policy. Agency leadership proposed the pilot to provide for broader surveillance coverage, enabling FDA to assess more facilities and gather additional critical insights without compromising regulatory rigor. FDA is targeting lower-risk establishments for the one-day assessment, while higher-risk and more complex facilities and operations will continue to be inspected under the traditional model.
Multiple FDA inspectorates are included in the pilot, notably, human and animal foods, biologics, medical products (i.e., drugs and devices), and clinical research programs. FDA reports that 46 such assessments have been conducted. FDA’s press release did not disclose details describing the breakdown of the product categories that have been assessed. Reportedly, most of the 46 assessments confirmed the facility’s compliance and were categorized as No Action Indicated (NAI), meaning no issuance of Form FDA 483 Inspectional Observations. FDA plans to continue the pilot through fiscal year 2026 (ending September 30, 2026).
As with any inspection tool, if concerns are identified during a one-day inspectional assessment, FDA reserves the right to conduct a comprehensive inspection. Therefore, if significant objectionable concerns are identified during the one-day assessment, the investigator can extend the investigation’s duration and scope and conduct a typical inspection, spanning multiple days on-site. According to FDA’s press release, although most of the assessments confirmed compliance, a portion of them were extended beyond the one-day assessment because significant observations were identified.
The one-day assessments provide FDA with an additional inspection tool, but not all sites or situations will meet the criteria for an assessment. Specifically, the assessments are to be utilized for surveillance compliance activities and are not applicable to pre-license or pre-approval inspections supporting applications, licenses, or supplements. Pre-license and pre-approval inspections will continue to be performed in accordance with the lead center’s compliance program and will take a multi-day, multi-system inspection approach. In addition, the assessments do not apply to higher-risk or more complex facilities; these facilities will continue to be inspected in the traditional fashion. Further, we do not expect FDA to use one-day inspectional assessments in place of “for-cause” inspections or compliance follow-up inspections.
Selection Considerations
FDA reports that facilities are selected for one-day inspectional assessments using risk-based criteria, such as product type, prior inspection outcomes, and operational characteristics. In his remarks at the Food and Drug Law Institute’s Annual Conference, on the same day as FDA’s press release, FDA Commissioner Martin A. Makary, MD, MPH, announced this pilot program and revealed the use of artificial intelligence in selecting facilities for one-day inspectional assessments. In prior announcements, FDA touted the use of its internal AI program, ELSA, to identify high-priority inspection targets.2FDA News Release: FDA Launches Agency-Wide AI Tool to Optimize Performance for the American People, dated June 2, 2025. On the same day as the press announcement for the one-day inspectional assessment, FDA also announced the launch of ELSA 4.0, highlighting a significant upgrade to the AI tool, including advanced evaluation features which can be used for site compliance evaluation.3FDA News Release: FDA Expands AI Capabilities and Completes Data Platform Consolidation, dated May 6, 2026. For instance, ELSA can be used to evaluate quality metrics, including deviations and CAPAs, to identify trends that may be overlooked by an investigator; these trends may reveal a systemic concern that is not being properly addressed. There is reason to believe ELSA’s evaluation of the metrics may be guiding selection of sites for one-day assessments.
King & Spalding expects that site selection will turn on a combination of factors related to a facility’s inspection history and production operations. Such factors are likely to include:
- Date of the last inspection or remote regulatory assessment
- Historical inspection classifications (e.g., site with history of inspections classified as NAI would likely be assigned lower risk than a site with an inspection classified as Official Action Indicated (OAI))
- Risk-based evaluation of observations cited in previous inspections (e.g., data integrity observations would be assigned a higher risk level than procedural update observations)
- History of a Warning Letter or OAI inspection classifications
- Manufacturing history of given product type
- Manufacturing conditions (e.g., sterile manufacturing could be assigned higher risk than non-sterile manufacturing operations), and
- Manufacturing location (e.g., facilities in China and India have a higher propensity for significant inspection observations leading to OAI classifications and Warning Letters over facilities in U.S., Europe).
We anticipate that ELSA is evaluating past trends and data points to determine which sites are low risk and appropriate for a one-day inspectional assessment.
Another Tool in the Inspectional Toolbox
FDA acknowledges one-day inspectional assessments are part of a broader initiative to make the Agency’s inspectional resources more targeted and efficient. Currently, the Agency has multiple other inspection-related tools in its toolbox, including remote regulatory assessments that can involve records requests in advance of or in lieu of an inspection and remote livestream video observation of operations. Presumably, the Agency may utilize its remote regulatory tools to aid its evaluation of records and data to streamline the focus during a one-day inspectional assessment. With this scenario, quality records (such as deviations, investigations, and CAPAs) can be reviewed in advance to identify higher-risk concerns and items needing follow-up during the on-site assessment; such up-front documentation review would allow the investigators to be laser-focused on facility conditions while on-site, rather than spending time on paperwork evaluations.
Are Assessments Likely to Continue?
FDA Associate Commissioner for Inspections and Investigations, Elizabeth Miller, Pharm.D., has acknowledged that data collected in the one-day assessment pilot will be analyzed across operational and compliance metrics, along with trending outcomes, risk signals, and investigator feedback, to determine how the pilot can enhance the broader inspectional strategy. FDA is developing metrics to assess effectiveness, including inspection duration, escalation rates, and the utility of findings in informing risk-based decision-making. Once the metrics are established, FDA is likely to rely on ELSA to determine which sites may be targeted for a one-day assessment. Additionally, as staff shortages (especially of investigators and inspectors) continue to plague the Agency, one-day assessments are likely to become a permanent inspection tool to help the Agency meet its inspectional demands.4GAO-25-106775 FDA Should Implement Strategies to Retain Its Inspection Workforce, Published: November 13, 2024, available here.
Preparation Strategies
To reap the benefits of a one-day assessment and minimize the risk that such an assessment will be converted to a multi-day traditional inspection, manufacturers must be able to showcase their sites and personnel while responding rapidly to requests for information. They must be able to demonstrate to FDA investigators that the site is operating in substantial compliance with current good manufacturing practices and is truly a low-risk compliance concern. Highlighted below are considerations for manufacturers in advance of a potential one-day assessment.
- First Impressions Matter. When investigators enter a facility, they rapidly assess overall site conditions and operations through a facility walk-through. The initial impression will be critical in assuring the investigator that the facility is well-maintained. Key focus areas are likely to include facility and equipment cleanliness; overall facility condition, including signs of disrepair, damage, pest infestation, utility drainage, or air filter blockage; presence of accumulated debris and clutter; sample management; personnel hygiene and gowning; and data integrity practices.
- Quality-Focused Culture. In addition to the state of the facility, the adequacy of quality management and personnel training will be under intense scrutiny during the assessment. Management and subject matter experts will be expected to immediately respond to inquiries and defend best practices as investigators will not have spare time to wait for crafted responses or for the knowledgeable person to be available. Quality management should remain up-to-date on outstanding and significant quality actions, as the investigator will come prepared to discuss quality events, especially if a records request was initiated prior to the visit. Companies who lead with quality-focused culture and with sufficient resources to dedicate to quality oversight are inherently able to respond to the rapid-paced demands of an assessment and will be well-positioned to showcase the capabilities of the site.
- Act Promptly. When investigators request documentation, firms should ensure that documentation can be readily produced so as to not delay swiftness of assessment evaluation. Delays can be viewed as stalling tactics and/or as an indicator of quality management deficiencies. With only hours to conduct an assessment, if multiple or key requests cannot be provided or addressed, investigators may well extend the assessment.
To identify potential pain points within the footprint of the facility and quality management gaps, King & Spalding can coordinate an attorney-client privileged mock audit. With King & Spalding’s extensive expertise in FDA matters, we can assist manufacturers in preparing their facilities ahead of a potential one-day assessment to increase the chances that FDA is satisfied and that the assessment is completed in one day.