One-Day Inspection Pilot Underway at FDA
FDA has launched a pilot program using one-day inspectional assessments as part of a broader effort to modernize its oversight model and deploy inspection resources more efficiently. The initiative is intended to introduce shorter, targeted facility reviews designed to complement, rather than replace, the agency’s traditional, multi-day inspections, according to an agency notice.
The pilot is part of an agency shift in its inspection strategy, which FDA commissioner Marty Makary discussed last month in an address to employees (see story). He said the agency is seeing a significant increase in unannounced inspections, particularly at overseas manufacturing facilities. Makary 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.
Makary said the new pilot is intended to expand the agency’s surveillance reach while maintaining regulatory standards. “One-day inspections can strengthen our inspectional approach by focusing our time and resources where they are most needed,” he said, adding that the model allows the agency to assess more facilities and gather critical compliance data with less disruption to industry operations.
As of late April, FDA has completed 46 one-day assessments. According to the agency, most resulted in “No Action Indicated” findings, meaning inspectors did not identify significant compliance issues.
The agency noted that while the assessments are designed to be completed in a single day, investigators retain discretion to extend the review if they uncover potential problems requiring deeper examination.
Beyond increasing inspection volume, FDA said the pilot is aimed at strengthening its risk-based oversight framework. Information gathered during the abbreviated inspections — including recurring compliance issues, discrepancies in facility operations, and facility-specific risk indicators — will be used to refine how the agency prioritizes future inspections.
FDA associate commissioner for inspections and investigations Elizabeth Miller said the agency is analyzing early data from the pilot to determine how the model can enhance its broader inspection strategy. “We are closely analyzing operational and compliance data from these assessments…to determine how this approach can enhance our broader inspectional strategy,” she said.
FDA emphasized that the one-day assessments are not intended to supplant traditional inspections, particularly for higher-risk or complex facilities that require more comprehensive review. Instead, the agency described the pilot as an additional tool that can provide faster feedback to lower-risk establishments while freeing up resources for more intensive inspections where needed.
Facilities selected for the pilot are chosen using risk-based criteria, including product type, compliance history, and operational characteristics. FDA said the program will continue through fiscal year 2026, with additional assessments planned. The agency is also developing performance metrics — including inspection duration, escalation rates, and the usefulness of findings in risk modeling — to evaluate the pilot’s effectiveness.