Be Prepared for New One-Day FDA Inspections: Law Firms

As FDA rolls out a pilot program featuring abbreviated, one-day inspections of lower-risk manufacturing facilities, law firm Hogan Lovells is advising pharmaceutical and medical device companies to maintain full inspection readiness despite the streamlined format. The initiative is intended to introduce shorter, targeted facility reviews designed to complement, rather than replace, the agency’s traditional, multi-day inspections (see earlier story).

The pilot is part of an agency shift in its inspection strategy. Lately, FDA has said there has been a significant increase in unannounced inspections, particularly at overseas manufacturing facilities. In the past, FDA has criticized pre-announced inspections as ineffective and said the agency is rebalancing oversight to ensure more rigorous, surprise inspections globally. He added that artificial intelligence is being deployed to identify high-risk facilities and improve inspection targeting.

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,” the law firm’s new analysis says. “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.”

Hogan Lovells advises that facilities with an analytical or biological laboratory 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.”

The analysis notes that there will likely be more FDA scrutiny of 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.”

Meanwhile, a Foley and Lardner legal update offers these pilot key takeaways:

• Perpetual readiness over “inspection readiness” — With shorter inspection windows, facilities cannot rely on last-minute document assembly. Robust quality systems, audit-ready records, and personnel who can clearly articulate processes under time pressure will become critical.
• Pre-inspection remote assessments may expand — The model appears to rely more heavily on documentation and data review before. or instead of during, the onsite assessment. Electronic systems, data integrity, and rapid export capabilities may therefore become even more important. Institutions and facilities should ensure that documentation is up-to-date and available upon immediate request.
• Low-risk status as a strategic asset — Companies that consistently demonstrate strong compliance histories and mature pharmaceutical quality systems may be more likely to qualify for these streamlined assessments, potentially reducing operational disruption and costs. Conversely, any history of inspection findings or recurring compliance concerns may keep a facility in the traditional, “full inspection” category. Institutions and facilities should continue strengthening FDA and research compliance programs, specifically around documentation retention and completeness, and compliance with policies and procedures.
• Clinical research and medical products sites should prepare — Sponsors, Clinical Research Organizations, device, drug and biologics manufacturers should consider incorporating one-day assessment scenarios into mock inspections and internal audit exercises.
• Documentation and response strategy —  While the 15-day statutory windows for responding to a Form FDA 483 remains unchanged, facilities should prepare for heightened operational pressure. The current regulatory environment demands earlier identification of risks and a more robust audit-ready response strategy.

Foley and Lardner says the pilot may signal a "meaningful evolution in how FDA allocates inspectional resources and evaluates compliance risk. Although the initiative is framed as a streamlined assessment model for lower-risk facilities, it also reflects FDA’s broader movement toward AI-assisted oversight, data-driven enforcement, and more dynamic inspection strategies. For regulated entities, the practical implication is clear: facilities may be expected to demonstrate real-time operational compliance with far less advance preparation time and fewer opportunities to address deficiencies during a prolonged inspection. Organizations that maintain strong quality systems, accessible documentation, and a culture of continuous compliance will likely be best positioned as FDA continues modernizing its inspection framework."

Now that former commissioner Mary Makary has left the agency, there are lingering questions on whether the pilot will maintain senior leadership backing, according to the firms' analyses. They note that to date there has been no issued guidance document, compliance manual update, or Federal Register notice discussing the program.

The pilot is expected to continue through FY-2026, with additional assessments planned across inspectorates. The agency is working on evaluation metrics that include inspection duration, escalation rates, and the utility of findings in informing risk-based decision-making.