FDA one-day inspections pilot: What to expect and how to prepare

What FDA announced

• FDA is conducting the pilot across multiple FDA inspectorates, covering human and animal foods, biologics, medical products, and clinical research programs, and is selecting facilities using risk-based criteria such as product type, prior inspection outcomes, and operational characteristics. FDA Associate Commissioner for Inspections and Investigations Elizabeth Miller—speaking at the Food and Drug Law Institute (FDLI) Annual Conference attended by Hogan Lovells lawyers—confirmed that FDA is directing one-day assessments at entities with strong compliance histories.
• Former FDA Commissioner Marty Makary also commented on the pilot’s components at a separate FDLI session. Makary described the one-day assessments as screening inspections directed at facilities that FDA’s AI flags as lower-risk, with the stated goal of enabling the agency to conduct a greater overall number of inspections.
• Overall, the pilot does not apply to higher-risk or more complex facilities that require more comprehensive inspectional coverage. Nor will the pilot replace standard inspections with one-day inspections or change enforcement policy.
• FDA has completed approximately 50 one-day assessments to date, with most classified as No Action Indicated (NAI), and with a limited number of those inspections being device related.

A screening may become a full inspection

Investigators may expand the scope or duration of an assessment if the situation calls for it, and the pilot has already demonstrated flexibility. FDA had indicated that some assessments have extended beyond one day once investigators made “significant observations"; Makary confirmed this point at FDLI Conference. Associate Commissioner Miller further confirmed at the FDLIthat a one-day assessment can be converted to a full investigation if circumstances warrant and may result in issuance of a Form 483. She also noted that whether a one-day assessment is announced in advance is discretionary—investigators may or may not provide notice.

Assessments will inform risk model development

FDA plans to use one-day assessments to gather data—including recurring compliance themes, facility-specific risk scores, and discrepancies between registered and actual operations—that will refine its risk models and focus the targeting of future oversight activities. A one-day visit resulting in an NAI outcome is therefore not simply a closed file; it generates data that may determine whether and when a facility is selected for a more comprehensive inspection.

Practical considerations for industry

Manufacturers who fit the target profile for the pilot, i.e., those that manufacture relatively low-risk products and that have not been inspected for several years, should prepare for a one-day assessment. Although the list of preparations could be long, at a minimum key personnel should review procedures for inspections, update lists of subject matter experts, tour the facility with the critical eye of an FDA investigator, and keep an opening meeting slide deck updated and at the ready. Device manufacturers should be familiar with FDA's new inspection policy, CP 7382.850, and be mindful of FDA's current focus on risk management throughout the product lifecycle, as well as executive management's role in quality system governance. Facilities with an analytical or biological laboratory, at a minimum, should self-audit for adherence to good documentation practice and data integrity principles. Generally, firms should assess the site's ability to access and present CGMP or BIMO documentation on demand; the more efficiently FDA investigators' requests for documents are fulfilled, the sooner the investigators are able to depart.

Overall, inspection readiness can be costly and time consuming, but it is typically a fraction of the time and costs needed to address FDA inspection observations. With more “FDA eyes” looking at more facilities that may not have been inspected for several years, and with investigators having the flexibility to extend an assessment, manufacturers should consider preparing with the same rigor applicable to any FDA inspection; first impressions matter more now than ever. Accuracy in establishment registration is also worth reviewing, given FDA's stated interest in identifying discrepancies between registered and actual facility operations.

What to expect going forward

FDA's one-day inspectional assessment program appears to have been a key initiative advanced during former Commissioner Makary's tenure and positioned as part of a broader effort to make inspectional activities more targeted and risk-based. The agency has described the program as a pilot that is currently underway; however, given the recent leadership transition, there are open questions as to how the program will evolve and whether it will be maintained or adjusted going forward. In addition, FDA has issued no formal guidance document, program compliance manual entry, nor Federal Register notice in connection with the pilot as of this alert's publishing.

Nevertheless, the pilot follows FDA's announcement last year that it was expanding unannounced inspections at foreign manufacturing facilities, in a signal that the agency has been moving toward broader and more flexible overseas oversight well before this pilot launched, as we previously discussed online here.

FDA said the pilot will continue through FY-2026, with additional assessments planned across inspectorates. FDA is developing evaluation metrics that include inspection duration, escalation rates, and the utility of findings in informing risk-based decision-making.

As we continue to monitor for pilot updates, feel free to reach out to any of the authors of this alert with any questions about your inspection preparedness.

Authored by Ted Lis, Jodi Scott, Mike Heyl, Gabrielle Simeck, and Chris Middendorf